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A B S T R A C T S

Poster Abstracts
First Annual Chicago Supportive Oncology Conference
Chicago, Illinois
October 6–8, 2005

Pain Mean NRS pain score


SATIVEX
5.68
TETRANABINEX
5.77
PLACEBO
6.05
P VALUEa

Abstract PA-1 (ITT, Baseline)


Cannabis-Based Medicines in the Treatment Change in NRS pain –1.37 –1.01 –0.69 0.0142
score (ITTb)
of Cancer Pain: A Randomized, Double-
Change in NRS pain –1.41 –0.94 –0.59 0.0047
Blind, Parallel Group, Placebo-Controlled, score (per protocolb)
Comparative Study of the Efficacy, Safety, and Change in NRS pain –1.55 –1.18 –0.71 0.0090
Tolerability of Sativex and Tetranabinex in score (completed patientsb)
Patients With Cancer-Related Pain P value for comparison of Sativex versus placebo; banalysis of covariance
a

NRS = numerical rating scale; ITT = intent to treat


Jeremy R. Johnson1, Stephen Wright2
1
Severn Hospice, Bicton Heath, Shrewsbury, United Kingdom; 0.02 [Wilcoxon]; appetite: P = 0.02 [ANCOVA]) and a similar
2
GW Pharma Ltd, Salisbury, United Kingdom trend for Tetranabinex. Both medicines were well tolerated.
CONCLUSIONS: A combination of CBD and THC appeared
BACKGROUND: This study compared the efficacy and tolerability to be more effective than THC alone. Further studies with a
of two cannabis-based medicines with placebo in the relief of cannabis-based medicine are indicated.
cancer pain. METHODS: Patients with cancer pain not wholly
alleviated with strong opioid treatment were treated for a
period of 14–21 days in addition to their ongoing strong opioid
analgesic. Patients self-titrated their study medication: each Abstract PA-2
100 µL oromucosal spray of Sativex delivered 2.7 mg delta-9- Assessment of Pain, Other Symptoms,
tetrahydrocannabinol (THC) and 2.5 mg of cannabidiol (CBD). Performance Status and Quality of Life in
Each 100 µL spray of Tetranabinex (a high THC content Children With Non-Hodgkin’s Lymphoma (NHL)
extract) delivered 2.7 mg THC. The primary outcome was the 1
Eleonora Mess, 2Wojciech Leppert, 1Adriana Borodzicz-Cedro,
change from baseline in numerical rating scale (NRS) pain score 3
Krzysztof Szmyd
at the end of 14–21 days of treatment. Secondary endpoints
Palliative Care Nursing Department, Public Health Faculty,
were Brief Pain Inventory Short Form, quality of life (European
Medical Academy, Wrocław, Poland1; Department of Palliative
Organization for Research and Treatment of Cancer Quality- Medicine, Poznan University of Medical Sciences, Poznan,
of-Life Questionnaire C-30), and 0–10 NRS scores for sleep Poland2; Department of Paediatric Bone Marrow Transplantation,
disturbance, nausea, memory, appetite, and concentration. Oncology and Hematology, Wrocław Medical University,
RESULTS: In all, 177 patients were randomized (n = 60 [Sativex], Wrocław, Poland3
n = 58 [Tetranabinex], n = 59 [placebo]). The NRS pain
score results appear in the table. There were no significant BACKGROUND: To evaluate the incidence of pain and other
differences in the usage of escape medication (number of symptoms, performance status, and global quality of life (QOL)
days on which escape was used [intent-to-treat]: Sativex vs in children diagnosed with NHL. METHODS: The study was
placebo, P = 0.91; Tetranabinex vs placebo, P = 0.41). There performed in 25 children (10 boys and 15 girls, aged 9–16 years)
were no statistically significant differences in the secondary diagnosed with NHL. The trial lasted from December 2004
endpoints in favor of Sativex or Tetranabinex, although there until June 2005. Patients answered questionnaires; interviews
was evidence of small, but statistically significant, reductions were conducted with children and their parents. Pain was
in concentration and appetite for Sativex (concentration: P = assessed with a visual analogue scale with colors from 0 = no
J Support Oncol 2005;3(suppl 3):XX–XX © 2005 Elsevier Inc. All rights reserved. pain (brightest color) to 9 = unbearable pain (darkest color)

VOLUME 3, NUMBER 5, SUPPLEMENT 3 ■ SEPTEMBER/OCTOBER 2005 www.SupportiveOncology.net 21


2005 Chicago Supportive Oncology Conference

and subsequently was classified into three groups: weak pain in postural control and physical mobility. Future studies to
intensity (0–3), moderate (4–6), or strong (7–9). Another develop interventions to help patients with CIPN are planned.
28 symptoms were assessed using the Rotterdam Symptom Some of these recommendations have included: use of adaptive
Checklist (RSC). Performance status was assessed by the equipment such as button hooks and elastic laces, referral to
Karnofsky scale (0%–100%). Global QOL was assessed by a physical therapy for balance and mobility assessment and training,
questionnaire. RESULTS: Pain intensity assessment: weak (72%), and management of neuropathic pain. These problems can be
moderate (20%), and strong (8%). The most frequent symptoms addressed appropriately by multidisciplinary approaches.
reported were fatigue (68%), loss of energy and weakness (56%),
abdominal pain (52%), oral lesions (52%), irritation (48%), and
worrying (48%). Karnofsky performance status: 20% (n = 3),
50% (n = 2), 60% (n = 9), 70% (n = 2), 80% (n = 2), 90%
(n = 2), and 100% (n = 5). Global QOL: very good (16%), Anemia/Fatigue
good (40%), rather good (20%), average (16%), rather poor Abstract PA-4
(4%), and very poor (4%). CONCLUSIONS: Weak and moderate
Patient-Reported Fatigue in Three Sunitinib
pain correlated well with the number of children with rather
Malate (SU11248) Phase II Trials for the
good, good, or very good global QOL. Strong pain in 2 children
Treatment of Advanced Renal Cell Carcinoma,
correlated with the 2 children reporting rather poor or very
Gastrointestinal Stromal Tumor, and
poor global QOL. The number of children (n = 22) reporting
Neuroendocrine Tumor
performance status as either moderate (50%–60%) or good
(70%–100%) correlated with the percentage of children with Jennifer L. Beaumont1, David Cella1, Jim Z. Li2, Xin Huang2,
very good, good, and rather good QOL (n =19; 76%). Paul Bycott2, Charles Baum2 and the SU11248 GIST, RCC, and
NET study teams
1
Center on Outcomes, Research and Education (CORE),
Evanston Northwestern Healthcare, Evanston, Illinois; 2Pfizer
Abstract PA-3
Inc., San Diego, California
Evaluation and Treatment Recommendations
for Taxane-Induced Peripheral Neuropathy in
Women with Breast Cancer B ACKGROUND : Sunitinib malate is an oral multitargeted
tyrosine kinase inhibitor with both antiangiogenic and
Meredith Wampler1,2, Ernest Rosenbaum1, Christine Miaskowski3 direct antitumor activities. This analysis describes patient-
1
University of California, San Francisco; 2Graduate Program in reported fatigue data from three phase II trials of sunitinib
Physical Therapy, San Francisco State University; 3Department for the treatment of metastatic renal cell carcinoma (RCC),
of Physiological Nursing, University of California, San Francisco malignant gastrointestinal stromal tumor (GIST), and advanced
unresectable neuroendocrine tumor (NET). Clinical results
BACKGROUND: A major problem in cancer treatment is the from these trials have been reported elsewhere. Fatigue was
development of chemotherapy-induced peripheral neuropathy further assessed after phase I trials had shown this to be a
(CIPN). Identifying feasible and valid measures of peripheral dose-limiting toxicity. METHODS: Sunitinib was administered
neuropathy will lead to practical solutions for the symptoms once daily in repeated cycles of 4 weeks on treatment, 2 weeks
and functional limitations associated with CIPN. This study off. Patient-reported fatigue was assessed weekly using the
reviewed the clinical assessment and explored the treatment of Functional Assessment of Chronic Illness Therapy-Fatigue
CIPN. METHODS: A pilot study at the University of California, (Fatigue) scale (scores: 0–52, higher scores = less fatigue) in the
San Francisco Comprehensive Cancer Center evaluated first 4 cycles (6 months). We report data from 63 patients in the
20 women with breast cancer who were taking taxane RCC trial, 55 in the GIST trial, and 102 in the ongoing NET
chemotherapy. Measures included several measures of CIPN, trial (n = 220). RESULTS: Baseline mean Fatigue scores of RCC,
postural control (balance), physical performance, pain, and GIST and NET patients were 40.4, 37.6, and 39.8, respectively,
quality of life. RESULTS: The most significant findings in this all lower (ie, reflecting more fatigue) than the general US
study were 1) 70% of the women experienced pain, yet only population’s average of 43.6. Baseline fatigue correlated with
45% were taking pain medications; 2) the most intense qualities baseline ECOG performance scores in all trials: patients with a
of the pain were numbness, tingling, unpleasantness, and better performance score reported less fatigue. During the first
aching; 3) impairments in balance and physical performance 4 cycles of therapy, the mean fatigue changes from baseline
were significant; and 4) the modified total neuropathy score scores ± SD in each trial were –2.2 ± 7.8 (RCC), 2.2 ± 8.8
correlated with measures of quality of life, balance, and physical (GIST) and –1.8 ± 8.1 (NET), all smaller than the established
performance. CONCLUSIONS: Peripheral neuropathy is a common minimally important difference of 3 points for the Fatigue scale.
side effect of taxane chemotherapy and frequently is not properly The changes from baseline scores did not differ with response to
evaluated. A majority of patients in this study were found to therapy in the 3 trials. Within treatment cycles, the mean scores
have occult, painful sensory neuropathies as well as impairments decreased slightly (reflecting more fatigue) during the 4 weeks

22 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

on treatment and increased (reflecting less fatigue) during the Abstract PA-6
2 weeks off treatment. This pattern generally was consistent in The Effectiveness of Darbepoetin Alfa
all 4 cycles and for all 3 trials. CONCLUSIONS: Patient-reported Administered Every 3 Weeks on Clinical
outcome data indicate that sunitinib did not cause a significant Outcomes in Elderly Patients With
clinically meaningful change in patient-reported fatigue in these Chemotherapy-Induced Anemia
3 trials. However, within treatment cycles, patients reported
Ralph Boccia1, Peter Silberstein2, Simon Tchekmedyian3, Dianne
slightly more fatigue while on treatment and less fatigue while Tomita4, Greg Rossi4, and Greg Otterson5 on behalf of the
off treatment. Aranesp Synchronicity (20030206) Study Group
1
Center for Cancer and Blood Disorders, Bethesda, Maryland;
2
Creighton University, Omaha, Nebraska; 3Pacific Shores Medical
Group, Huntington Beach, California; 4Amgen Inc., Thousand
Abstract PA-5 Oaks, California; 5Ohio State University, Columbus, Ohio
Communication Regarding Chemotherapy-
Induced Anemia and Related Fatigue: BACKGROUND: Chemotherapy-induced anemia (CIA) is common
Recommendations From an Observational in patients receiving chemotherapy with adverse effects on clinical
Linguistic Study outcomes and quality of life. METHODS: We present an exploratory
analysis from a large, multicenter, open-label, 16-week study of
D. Blum, D. Cella, B. Davidson, H. Hamilton, L. Nail,
the effectiveness of every-3-week (Q3W) darbepoetin alfa 300 µg
R. Waltzman
in cancer patients with CIA. RESULTS: Results are presented for
BACKGROUND: Many instruments exist for determining the elderly (≥ 65 years [mean 73.7 years; n = 724]) and younger (<
impact of chemotherapy-induced anemia and related fatigue on 65 years [mean 52.1 years; n = 769]) patients. Most patients were
patient quality of life, but few studies analyze how healthcare female (52% and 69%, respectively). The most frequent cancer
providers actually discuss anemia and fatigue with patients. type varied: gastrointestinal (27%) in elderly and breast cancer
METHODS: Letters of invitation were mailed to over 1,000 (41%) in younger patients. Mean (SD) baseline hemoglobin
community-based oncologists; of these, 15 met the criteria levels were identical (10.1 [0.7] g/dL in both groups). Similar
and agreed to participate in this research. Thirty-six patients percentages of patients in each group had a baseline hemoglobin
undergoing chemotherapy were videorecorded during regularly level < 10 and ≥ 10 g/dL (31% and ~60%, respectively). A high
scheduled visits. Post-visit interviews were conducted separately percentage of patients (95% CL) achieved target hemoglobin
with patients and physicians and/or allied health professionals. (11–13 g/dL): 79% (76, 82) in both groups, with 73% of patients
Interviews were transcribed and analyzed using sociolinguistic in each group subsequently maintaining these levels. Red blood
techniques. RESULTS: In all, 52% of visits were spent discussing cell transfusion requirements were reduced from months 1 to 4:
side effects and symptoms; 31% on hematologic issues (anemia 11% to 3% in elderly and 12% to 4% in younger patients. Mean
and related fatigue, blood counts, growth factors, etc). However, (95% CL) change in Functional Assessment of Cancer Therapy-
most discussions of fatigue/anemia lacked specificity and the Fatigue scores (baseline to week 16) differed by age: 2.9 (1.7,
time reference necessary to determine impact on patients’ 4.0) in elderly, and 6.4 (5.3, 7.6) in younger patients. The safety
lives. For example, the word “normal” or a surrogate was used profile was as expected for this patient population. CONCLUSIONS:
in 67% of visits, but without clarity to its reference (ie, without Darbepoetin alfa Q3W appears to be well tolerated and effective
reference to “normal symptom for someone with cancer,” for treating CIA in both elderly and younger patients. However,
“normal side effect for chemotherapy,” etc). Physician inquiries elderly patients experienced less improvement in quality of life
regarding fatigue also tended to be too brief to elicit patients’ scores than younger patients.
chief concerns. On average, less than one question/visit
relating to fatigue/anemia was asked of the patient. No fatigue-
assessment instrument was used or referenced, in whole or in
part, in any visit. CONCLUSIONS: Chemotherapy-induced anemia Abstract PA-7
and related fatigue were discussed, but not with the specificity Status of Anemia Management in Community
required to understand impact on quality-of-life. Community- Oncology
based oncologists are encouraged to modify their vocabulary (eg,
Barry Fortner, Ling Zhu, Lee S. Schwartzberg
use “expected” in lieu of “normal”) and consider incorporating
a simple instrument to improve communication. Accelerated Community Oncology Research Network, Memphis,
Tennessee
BACKGROUND: Despite available treatments and management
guidelines for chemotherapy-induced anemia, evidence suggests
a significant portion of patients continue to go untreated or
inadequately treated. This study is a pilot project aimed at
describing the status of anemia management in relation to

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2005 Chicago Supportive Oncology Conference

published guidelines and standards. METHODS: For each clinic, two the tablet during the 12-hour observation period, the time to
chart samples of 25 chronologically consecutive cancer patients achievement of measurable drug concentration was about 20
presenting to community oncology clinics on July 1, 2004, and minutes shorter for the 8-mg ondansetron oral spray versus 8-
September 1, 2004, were abstracted for quality parameters relating mg Zofran tablet. Also, at 20 minutes post dose, the oral spray
to the target visit. RESULTS: Results are from 977 patients (20 formulation significantly increased the total amount of drug
clinics) receiving chemotherapy. Patients were 60% female; mean delivered and the mean ondansetron plasma concentration relative
(SD) age of 62 (13) years; 78% Caucasian; 42% on Medicare; to the conventional oral tablet. CONCLUSIONS: Ondansetron oral
heterogeneous on cancer, stage, and chemotherapy; presenting for spray was safe and well tolerated.
visits involving a range of services (lab 70%, physician 51%, nurse
48%, chemotherapy 63%, erythropoietic therapy [either epoetin
alfa or darbepoetin alfa] 21%, growth factor 11%). Mean (SD)
hemoglobin (Hgb) was 11.8 (1.6) g/dL. Fifty-two percent (n = Abstract PA-9
506) of patients were receiving an erythropoietic agent, of which Post-Marketing Surveillance Data
11% were receiving iron supplementation (2% IV). Five percent Demonstrate a Favorable Safety Profile
of patients (n = 49) had received a red blood cell transfusion in of Palonosetron for Prevention of
the 4 weeks prior. Hemoglobin level by anemia severity, use of Chemotherapy-Induced Nausea and Vomiting
erythropoietin by anemia severity, description of anemia course, (CINV) in Clinical Practice
erythropoietin type and schedule, erythropoietin initiation by
Michael T. Cullen, Jr.1, Mary M. McGuiggan1, Mario Bertazzoli2
hemoglobin level severity, and rate of fatigue severity assessment
by type of visit were analyzed. CONCLUSIONS: Anemia was a
1
MGI Pharma Inc., Bloomington, Minnesota; 2Helsinn
Healthcare SA, Lugano, Switzerland
frequent problem for patients receiving chemotherapy. These data
will be important to collect on an ongoing basis to establish and BACKGROUND: Palonosetron hydrochloride (Aloxi) is a selective
maximize clinical outcomes in actual clinical practice. serotonin subtype 3 (5-HT3) receptor antagonist differentiated
from other 5-HT3 receptor antagonists by its high receptor
binding affinity and extended plasma half-life (~40 hours).
Palonosetron injection 0.25 mg is indicated in the United
States (US) for the prevention of acute and delayed nausea and
Emesis vomiting associated with moderately emetogenic chemotherapy
and the prevention of acute nausea and vomiting associated
Abstract PA-8
with highly emetogenic chemotherapy. The safety profile of
Enhanced Pharmacokinetic Profile of palonosetron demonstrated in the pivotal trials was similar to
Ondansetron Oral Spray other 5-HT3 receptor antagonists. Headache and constipation
Greg Berk1, Arkady Rubin2, Gavin Choy1 are the most frequently reported adverse reactions in this class.
1
Hana Biosciences, Inc., South San Francisco, California; Since the product has been launched, over 1.8 million vials
2
NovaDel Pharma, Inc., Flemington, New Jersey of Aloxi have been distributed. METHODS: An extensive post-
marketing surveillance (PMS) review was completed to evaluate
BACKGROUND: Ondansetron, a potent, highly selective, competitive Aloxi’s safety profile in the post marketing exposed patient
antagonist of 5-HT3 receptors, is the active ingredient of Zofran, the population for the reporting period from September 2003 up to
most broadly prescribed antiemetic. Ondansetron is approved for and including April 24, 2005. All spontaneous adverse events
the prevention of nausea and vomiting associated with emetogenic reported, including any adverse events from ongoing clinical
cancer chemotherapy or radiotherapy and for the prevention of trials, were collected and processed in the Helsinn Global Safety
postoperative nausea and vomiting. It is currently available in Database (ARGUS by Relsys Incorporated, US). RESULTS: PMS
tablet, orally disintegrating tablet, oral solution, and intravenous data from September 2003–April 2005 included 88 case reports.
formulations. We report the development of ondansetron oral Of these 88 spontaneous adverse event reports, 14 (16%) were
spray, a multidose oral spray dosage form of ondansetron that may considered serious, and 74 (84%) were considered nonserious.
offer certain advantages over the currently available formulations. The most frequently reported adverse events included headache
METHODS: This oral spray achieves therapeutic drug levels by (n = 16), hypersensitivity reactions (n = 8), and injection site
delivering small droplets of concentrated drug solutions over the reactions (n = 11). No instance of QT interval prolongation and
oral mucosa, which has a rich blood supply and has been found to one nonserious case of constipation were reported. In addition,
be permeable for the purpose of drug delivery. The pharmacokinetic only 22 cases of lack of efficacy were reported (0.0012%). With
profile of 8 mg of ondansetron oral spray was compared with an over 1.8 million doses distributed, these spontaneous PMS data
8-mg Zofran tablet in a pilot pharmacokinetic study conducted showed a favorable safety profile with very few cases reported
in 9 healthy adult male volunteers. RESULTS: Although the mean (n = 88, 0.0049%). CONCLUSIONS: With over 1.8 million doses
maximum plasma concentration and bioavailability as measured administered, PMS data confirmed a favorable safety profile for
by the area under the curve for the spray did not exceed that of palonosetron in clinical practice.

24 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

Abstract PA-10 hyoscine derivatives (second step); and finally levomepromazine


Control of Chemotherapy-Induced Nausea and octreotide (third step). METHODS: Clinical assessment of 420
Remains Suboptimal Despite Widespread Use patients with advanced cancer that suffered from chronic nausea
of Multiple-Day Ondansetron, Dolasetron, or and/or vomiting induced by different causes, including 95 patients
Granisetron Antiemetic Therapy diagnosed with inoperable bowel obstruction. The intensity of
symptoms was assessed by verbal scale, from 0 (lack of NV) to 3
Jane Hickok, Gary Morrow, Joseph A. Roscoe
(strong NV). Symptoms were assessed three times: 1) beginning
University of Rochester Cancer Center, Rochester, New York of care, 2) during symptomatic treatment, and 3) the last week of
BACKGROUND: Despite improvement in control of vomiting with life. Treatment was beneficial if there was a decrease from strong-
short-acting 5-HT3 receptor antagonists, nausea continues to or-moderate to mild-or-none NV, maintenance of mild NV, or
be a significant problem for patients receiving chemotherapy. complete disappearance of symptoms. Treatment was a failure
Short-acting 5-HT3 receptor antagonists appear to be prescribed when there was an increase in NV or when moderate or strong
widely on the days following chemotherapy for patients receiving NV was maintained. RESULTS: In all patients, beneficial effects
moderately emetogenic chemotherapy (MEC), despite high-level were seen in patients from beginning of care to symptomatic
evidence that they are not very effective for control of delayed treatment (n = 344; 82%) and from the treatment period to
nausea. METHODS: In total, 2,068 nurses were surveyed at the the last week of life (n = 357; 85%). In patients with inoperable
2005 Oncology Nursing Society 30th Annual Congress regarding bowel obstruction, beneficial effects were seen in patients from
perceptions of antiemetic prescribing in their clinical practices. beginning of care to symptomatic treatment (n = 56; 59%),
For comparison, nausea incidence rates for days 2 and 3 also were and from the treatment period to the last week of life (n = 49;
reported from a recently completed randomized clinical trial in 51%). CONCLUSIONS: Treatment of NV according to the proposed
which 226 patients received dexamethasone on day 1 and a short- three-step antiemetic ladder was beneficial in over 80% treated
acting 5-HT3 receptor antagonist on days 1–3 following MEC that patients. However, in over 15% of patients with gastrointestinal
included doxorubicin. RESULTS: The survey data demonstrated obstruction, control of NV was unsatisfactory, indicating a need
that 77% of practices routinely prescribe oral 5-HT3 receptor for more intensive treatment and more effective therapy methods
antagonists after day 1 of chemotherapy to prevent delayed in this group of patients.
nausea and vomiting. Results from the clinical trial showed that
the rate of delayed nausea in patients receiving a short-acting oral
5-HT3 on days 2 and 3 was almost 80%. CONCLUSIONS: For patients
receiving doxorubicin-based chemotherapy, daily administration Abstract PA-12
of short-acting 5-HT3 receptor antagonists on days 2 and 3 did Improving the Functional Status of Patients
not control nausea in the vast majority of patients. It is unclear With Cancer by More Effectively Preventing
why this practice pattern continues when better agents may be Chemotherapy-Induced Nausea and Vomiting
available to control this potentially debilitating side effect of (CINV): A Comparison of Palonosetron (PALO)
common chemotherapy. vs Ondansetron (OND) or Dolasetron (DOL)
Carl de Moor, 2Regina S. Cunningham
1

Children’s Hospital Boston, Harvard Medical School, Boston,


Massachusetts1; The Cancer Institute of New Jersey, New
Abstract PA-11
Brunswick2
The Use of the Three-Step Antiemetic
Ladder in the Treatment of Chronic BACKGROUND: More effective prevention of CINV at treatment
Nausea and Vomiting and in the Course initiation can improve the functional status of patients with
of Inoperable Bowel Obstruction in cancer and reduce consumption of caregiver resources. In two
Patients With Advanced Cancer pooled, phase III, randomized trials (n = 754), PALO 0.25 mg
demonstrated superior prevention of CINV compared with
1
Wojciech Leppert, 2Sławomir Paweł Wozniak, 1Jacek Łuczak
OND 32 mg or DOL 100 mg in patients receiving moderately
Department of Palliative Medicine, Poznan University of Medical emetogenic chemotherapy (MEC). METHODS: The Functional
Sciences, Poznan, Poland1; Palliative Care Department, Down Living Index-Emesis (FLIE) instrument assessed the impact of
Silesian Oncology Centre, Wrocław, Poland2
CINV on daily life activities in the first 24 hours (acute) and on
BACKGROUND: Nausea and vomiting (NV) are frequent symptoms days 2–4 (delayed) after chemotherapy. The FLIE is a validated,
in patients with advanced cancer. We submit results of using the patient-reported instrument with 9 questions in two domains
three-step antiemetic ladder concerning treatment of chronic (nausea and emesis), with responses scored on a 100-mm, 7-
NV in patients with and without inoperable gastrointestinal point visual analog scale (VAS) anchored by “none/not at all”
obstruction. For patients with inoperable bowel obstruction, (7) and “a great deal” (1). Higher VAS scores indicated less
we propose metoclopramide and dexamethasone (first step); impact on functioning, and “No impact on daily life” (NIDL)
followed by haloperidol, dimenhydrinate, promethazine, and was defined as an average score > 6. RESULTS: Significantly

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2005 Chicago Supportive Oncology Conference

ACUTE DELAYED and overall (0–120 hr) no emesis and complete response (CR:
PALO OND/DOL P VALUE PALO OND/DOL P VALUE no emesis, no rescue) rates. RESULTS: See table. CONCLUSIONS:
NIDL (% Patients) In challenging emetogenic situations such as with AC or HEC,
Nausea 66.9a 57.2 0.006 64.8a 53.7 0.001 PALO provides better overall protection from emesis than a
Emesis 79.1 72.6 0.077 79.4a 71.3 0.005 first-generation agent. Research supported by MGI Pharma,
Total 72.8a 63.6 0.006 70.4a 58.8 0.001 Inc. and Helsinn Healthcare, SA.
Mean FLIE Scores
Nausea 81.6a 76.2 0.011 81.7a 74.9 0.001
Emesis 87.1a 83.0 0.037 89.6a 84.6 0.003 AC HEC
PALO OND OR DOL PALO + DEX OND + DEX
Total 84.4a 79.5 0.014 85.6a 79.7 0.001
(n = 131) (n = 132) P VALUE (n = 150) (n = 147) P VALUE
a
PALO superior to OND/DOL; Mean scores adjusted for age, gender, alcohol, and prior che- No emesis (% patients)
motherapy experience and regimen. NIDL = no impact on daily life; FLIE = Functional Living
Index-Emesis Acute 73%a 50% < 0.001 75%a 59% 0.003
Overall 57%a 31% < 0.001 53%a 33% < 0.001
more PALO-treated patients reported NIDL and had higher CR (% patients)
FLIE scores. A further evaluation of the FLIE scores by quartile Acute 63%a 47% 0.013 65% 55% 0.125
revealed the greatest differences to be in patients with the most Overall 47%a 24% 0.001 41%a 25% 0.005
interference in daily functioning (see table). CONCLUSIONS: a
PALO superior to OND/DOL. AC = anthracycline-cyclophosphamide; HEC = highly emeto-
genic chemotherapy; CR = complete response
These FLIE analyses suggest that improved control of CINV
with PALO allows more patients to maintain their functional
status after MEC. This more effective antiemetic should result
in improved patient quality of life and should ease management
for oncology care providers. Abstract PA-14
Cost Comparison of Palonosetron to Short-
Acting Serotonin Receptor Antagonists (SRAs)
for the Prevention of Acute and Delayed
Abstract PA-13 Chemotherapy-Induced Nausea and Vomiting
Single-Dose Palonosetron is Superior to (CINV)
Single-Dose Ondansetron or Dolasetron Lee S. Schwartzberg1, Gordon J. Vanscoy2
in Preventing Emesis in Patients Receiving 1
The West Clinic, Memphis, Tennessee; 2University
Highly Emetogenic Chemotherapy (HEC) or Pharmacotherapy Associates, LLC, Monroeville, Pennsylvania
Anthracycline-Cyclophosphamide (AC)-Based
Chemotherapy for Breast Cancer BACKGROUND: Palonosetron (PALO) offers improved acute
and prolonged CINV control versus short-acting SRAs and
Hope S. Rugo1, Steven M. Grunberg2
can provide a cost-effective alternative for patients, medical
1
University of California San Francisco Comprehensive Cancer practitioners and payers. Efficacy of PALO and analysis of both
Center, San Francisco; 2University of Vermont, Burlington upfront and downstream costs are considerations in an overall
BACKGROUND: Acute chemotherapy-induced emesis is the economic model from a payer perspective. METHODS: Complete
greatest predictor for emesis in the subsequent days or cycles. response (CR, no emesis, no rescue) rates for ondansetron,
Palonosetron 0.25 mg (PALO), has demonstrated superior, dolasetron or granisetron (OND/DOL/GRAN) given on day
prolonged efficacy versus first-generation agents in patients 1, with SRA follow-up for the delayed period (days 2–5), were
receiving a variety of emetogenic chemotherapy agents. Emesis compared with CR rates for day 1 PALO (with no follow-up)
resulting from AC-based chemotherapy and highly emetogenic from literature. An economic model comparison was made
agents like cisplatin is difficult to manage and results in between patients receiving 1-day PALO versus 3-day OND
decreased quality of life for many patients. Acute antiemetic (IV Day 1, twice daily oral follow-up) therapy. Total costs
protection with PALO could improve the overall management were estimated as total antiemetic costs plus total medical and
of these challenging chemotherapeutic situations. METHODS: pharmacy costs associated with extreme CINV events for 6
Efficacy of single-dose PALO versus single-dose ondansetron months. Drug acquisition costs were based on average wholesale
32 mg (OND) or dolasetron 100 mg (DOL) was evaluated price (AWP) discounted at 20% for Day 1 intravenous drug and
in the subset of women with breast cancer receiving their wholesale acquisition cost (WAC) for oral follow-up therapy.
first cycle of AC chemotherapy in two multicenter, double- It was assumed that 4% of PALO- and 11% of first-generation
blind, randomized, controlled trials. Efficacy of PALO + 5-HT3 receptor antagonist-treated patients would experience
dexamethasone (DEX) versus OND + DEX was evaluated in an extreme event, per published literature. Estimated direct
patients receiving HEC in a third trial. Patients received PALO medical (including pharmacy) costs associated with these
or OND/DOL (± DEX) prior to chemotherapy, with no follow- events were included in the model (Shih et al, J Clin Oncol
up antiemetics. Efficacy measurements included acute (0–24 hr) 2005, Abstract 6053). RESULTS: PALO results in 18%–19%

26 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

higher acute and delayed CR rates than OND/DOL/GRAN (P Abstract PA-16


< 0.01). A net savings of $1.0M for every 1,000 patients could Oral Mucositis Incidence and Severity
be obtained when using 1-day PALO instead of 3-day OND Reduced With AES-14: Results of a Phase III
therapy. The net savings ranged from $0.9M to $1.1M for every Pivotal Trial in Patients with Breast Cancer
1,000 patients regardless of the first-generation SRA chosen.
Douglas E. Peterson1, Robert G. Petit II2
CONCLUSIONS: The use of PALO instead of short-acting SRAs
not only provided patients with improved CINV control, but
1
University of Connecticut Health Center, Farmington; 2MGI
Pharma Inc., Bloomington, Minnesota
reduced the overall costs to payers of managing these distressing
side effects, also impacting practices and society. BACKGROUND: Oral mucositis (OM) is a common toxicity
secondary to high-dose chemotherapy (CT) and can cause
CT-dose limitation in patients. This randomized, double-blind,
placebo controlled, phase III crossover study evaluated the efficacy
and safety of L-glutamine administered via a proprietary oral drug
Mucositis delivery system (UpTec) in breast cancer patients receiving
anthracycline-based CT regimens. The primary objective was
Abstract PA-15
to compare incidence and severity of moderate-severe (World
Palifermin Is Safe and Well Tolerated in Health Organization [WHO] grade ≥ 2) OM during AES-14
Patients With Hematologic Malignancies (HM) versus placebo treatment. METHODS: A total of 326 of 2,084
Undergoing High-Dose Chemoradiotherapy subjects developed WHO grade ≥ 2 OM during the screening CT
(HD-CRT) Followed By Allogeneic cycle. These 326 subjects were randomized in a 1:1 ratio to receive
Hematopoietic Stem Cell Transplantation AES-14 (n = 163) or placebo (n = 163), administered as a 5 mL
(Allo-HSCT) dose three times a day during their next CT cycle (Treatment
B. Blazar1, D. Weisdorf1, T. DeFor1, A. Goldman1, S. Silver1, Cycle 1). Patients then received the alternate treatment during
J.L.M. Ferrara2 the next cycle of CT (Treatment Cycle 2). Efficacy was assessed
University of Minnesota, Minneapolis1; University of Michigan, by evaluation of the oral mucosa using WHO Toxicity Criteria
Ann Arbor2 and the Oral Mucositis Assessment Scale. Safety was assessed by
adverse events, physical examination, and laboratory evaluations.
BACKGROUND: Palifermin reduces the incidence and duration RESULTS: Primary efficacy analysis focused on Treatment Cycle
of severe oral mucositis (OM) in patients with HM receiving 1 data only, due to a significant carryover effect in Treatment
myelotoxic therapy requiring HSCT. In the allogeneic transplant Cycle 2. Incidence of WHO grade ≥ 2 OM was significantly
setting, graft-versus-host disease (GVHD) is the limiting reduced for AES-14 treated patients (38.7%) compared with
complication. Palifermin’s safety, tolerability, and effect on placebo (49.7%; P = 0.026). Incidence of WHO grade ≥ 3 OM
acute GVHD were evaluated in a phase 1 trial of HM patients was significantly lower in AES-14 treated subjects (1%; 2/163)
requiring allo-HSCT. METHODS: Patients were randomized (1 versus the placebo cohort (7%; 11/163; P = 0.0047). The
placebo: 2 palifermin) to one of three sequential cohorts (stage carryover effect favored AES-14, whereby those who received
1, 2, or 3), receiving 3 doses of study drug before HSCT and AES-14 during Treatment Cycle 1 had a lower than expected
3, 6, or 9 doses post-HSCT. Safety evaluation included 100- rate of OM when they received placebo in Treatment Cycle 2.
day and 1-year survival/relapse rates. Secondary endpoints Incidence of study drug treatment-emergent adverse events was
included the incidence of OM. RESULTS: 100 patients were comparable in both cohorts. CONCLUSIONS: AES-14 significantly
randomized to stage 1, 2, or 3. Twenty patients (2 placebo,18 reduced incidence of clinically significant OM associated with
palifermin) discontinued the study. Of these, 6 patients (2 anthracycline-based CT and could be administered safely. Study
placebo, 4 palifermin) experienced a total of 11 dose-limiting has been supported by Aesgen Inc. (until September 2004) and
toxicities (DLTs). Discontinuations and DLTs were most MGI Pharma Inc. (October 2004—present).
common in patients who received at least 6 doses of study
drug after engraftment (day 0). Eighteen patients (5 placebo,
13 palifermin) died prior to day 100, primarily due to HSCT
complications. No significant differences in the time to absolute
neutrophil count or platelet engraftment, or on survival, relapse
rates, or acute GVHD were observed. Palifermin appeared to
have a beneficial effect on OM. CONCLUSIONS: Palifermin is
generally safe and well-tolerated in the allo-HSCT setting,
did not have negative effects GVHD or survival rates, and
appeared to have a beneficial effect on OM.

VOLUME 3, NUMBER 5, SUPPLEMENT 3 ■ SEPTEMBER/OCTOBER 2005 www.SupportiveOncology.net 27


2005 Chicago Supportive Oncology Conference

Abstract PA-17 survival, and secondary malignancy incidences were similar and
No Difference on Long-Term Disease not unexpected for this pt population. CONCLUSIONS: Palifermin
Outcomes Between Patients With use had no impact on long-term disease outcomes, including
Hematologic Malignancies (HM) Treated with survival, in the HSCT setting.
Palifermin in the Autologous Hematopoietic
Stem Cell Transplant (HSCT) Setting
P. Stiff1, C. Emmanouilides2, U. Gayko3, Mon-Gy Chen3,
R. Spielberger4 Abstract PA-18
1
Cardinal Bernardin Cancer Center, Maywood, Illinois; 2UCLA
A Patient Self-Reported Daily Questionnaire
Medical Center, Los Angeles, California; 3Amgen Inc, Thousand Is a Feasible and Valid Tool in Oral Mucositis
Oaks, California; 4City of Hope National Medical Center, in Patients With Hematologic Malignancies
Duarte, California Undergoing High-Dose Chemoradiotherapy
(CRT) with HSCT
BACKGROUND: Oral mucositis (OM), a debilitating side effect
Patrick J. Stiff1, William I. Bensinger2, Christos Emmanouilides3,
of myelotoxic chemoradiotherapy, is often associated with Z. John Lu4, Alessandra Cesano4, Ricardo Spielberger5
significant pain and increased risk of complications. Palifermin, 1
Loyola University, Maywood, Illinois; 2Fred Hutchinson Cancer
shown to reduce the incidence and duration of severe OM in
Research Center, Seattle, Washington; 3UCLA David Geffen
HM patients receiving myelotoxic therapy and HSCT, should School of Medicine, Los Angeles, California; 4Amgen, Inc.,
not interfere with treatment outcomes, since the KGF receptor Thousand Oaks, California; 5City of Hope National Medical
is absent in HM. We report the long-term disease outcomes of Center, Duarte, California
palifermin-treated patients. METHODS: Patients participating in
4 trials (phase I–III and pharmacokinetic/pharmacodynamic) Background: Oral mucositis (OM) is a frequent complication of
and receiving one or more doses of investigational drug enrolled CRT and often is rated as the most debilitating treatment-related
into an ongoing, long-term follow-up study evaluating survival, side effect. In a pivotal phase 3 clinical trial of palifermin conducted
progression-free survival (PFS), and secondary malignancies. in the HSCT setting, patients (placebo = 106, palifermin = 106)
Patients were assessed at 6-month intervals during the first year were asked to assess their OM severity and functional limitations
and annually thereafter until death or loss to follow-up. The (swallowing, eating, drinking, talking, sleeping) through a self-
Kaplan-Meier (K-M) method provided estimates of the safety reported daily questionnaire (Oral Mucositis Daily Questionnaire
endpoints. Data reported here are as of August 2004. RESULTS: In [OMDQ]) while physicians used the World Health Organization
all, 650 patients (408 palifermin, 242 placebo) participated in the (WHO) clinical scale for measuring OM severity (WHO-OM).
parent trials; 538 patients enrolled in the long-term study. Median The feasibility and validity of the OMDQ were evaluated and are
follow-up was similar (23.8 months palifermin; 23.1 months reported here. METHODS: OMDQ feasibility was measured by daily
placebo), and the overall survival curves were superimposable compliance rate. Pearson correlation coefficients were computed
(Figure). In each group 26% of patients died, with most of the to measure test-retest reliability, internal consistency reliability,
deaths occurring within months 3–12 of randomization. PFS and discrimination validity. RESULTS: The mean daily compliance
was similar, with 6% of patients in each group experiencing a rate for OMDQ completion over the entire study period was at
secondary malignancy (the most common were myelodysplastic least 84% in both treatment groups. The Pearson correlation
syndromes and acute lymphocytic leukemia/ acute myelogenous coefficients ranged from 0.6–0.9, 0.5–0.8; and 0.3–0.6 for test-
leukemia). Based on these data, overall survival, progression-free retest reliability, internal consistency reliability, and discriminative
Kaplan-Meier Survival Curves for Palifermin and WHO and OMDQ Scores
Placebo Patients
100% 3.5
WHO mucositis grade, OMDQ score

3.0 WHO grade


80%
Percent survival

2.5 OMDQ score

60% 2.0

40% 1.5
Palifermin (n = 241)
1.0
Placebo (n = 409)
20%
0.5

0% 0.0
12 24 36 48 60 –12 –8 –4 0 4 8 12 16 20 24 28 32
Study month Study day
WHO = World Health Organization; OMDQ = Oral Mucositis Daily Questionnaire

28 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

validity, respectively. Figure 1 shows the distributions over time Abstract PA-20
of the average daily scores from the OMDQ (mouth and throat Patterns of Care and Incidence of
soreness) and WHO-OM. Although the shapes of the distribution Neutropenia-Related Complications During
curves were similar, there was a significant temporal difference. Chemotherapy and the Use of Pegfilgrastim
Patients reported onset, peak, and resolution of oral pain earlier and Filgrastim in Community Practice:
(1 to 3 days) than did their physicians, who were using the clinical Results of the ACCEPT Study
assessments. CONCLUSIONS: A daily diary could be used as a valid
Luis T. Campos1, Mitchell H. Folbe2, Veena Charu3,
alternative to clinical measurements of OM in clinical settings Jennifer Malin4, Beiying Ding4, Roger Dansey4
where the latter might be impractical. 1
Oncology Consultants, P.A., Houston, Texas; 2Medical
Oncology, Troy, Michigan; 3Pacific Cancer Medical Center, Inc.,
Anaheim, California; 4Amgen Inc., Thousand Oaks, California
BACKGROUND: We conducted a retrospective study comparing
Neutropenia patterns of care and neutropenia-related complications among
patients receiving pegfilgrastim in 2003 and patients receiving
Abstract PA-19
filgrastim in 2001. METHODS: Consecutive medical records (n
Pegfilgrastim Use in Older Patients (> 60 = 829, filgrastim; n = 1922, pegfilgrastim) were abstracted for
Years) Maintains Dose Intensity of Dose- adult chemotherapy patients from a random sample of 99 US
Dense Adjuvant Chemotherapy for Early- oncology practices, obtaining characteristics, treatment, and
Stage Breast Cancer neutropenia-related complications data. RESULTS: The most
R.E. Birhiray, R.T. Schmidt, J. Powell, R.M. Harwood common tumor types were breast (51%), lung (19%), and
Hematology-Oncology of Indiana, PC, Indianapolis, Indiana non-Hodgkin’s lymphoma (18%). There were no significant
differences in age (mean, 58 and 60 years for pegfilgrastim
BACKGROUND: Long-term survival in early-stage breast cancer and filgrastim, respectively) or prior neutropenia or febrile
(ESBC) correlates positively with > 85% relative dose neutropenia (4% and 5%, respectively). Pegfilgrastim was
intensity (RDI) and dose density of adjuvant chemotherapy initiated in cycle 1 in 62% of patients and used in cycle 2 by
(Bonnadonna,1995; Citron, 2003). A recent national survey 84%. Filgrastim was initiated in cycle 1 in 54% of patients and
reported that nearly 75% of patients receive < 85% RDI. used in cycle 2 by 78%. Growth factor was initiated within
Increased age and no first-cycle colony-stimulating factor 72 hours of chemotherapy in 86% of cycles for pegfilgrastim
have been identified as independent predictors for reduced patients but only 48% of cycles for filgrastim patients. Among
RDI (Lyman, 2003). This retrospective case study evaluates patients receiving filgrastim in cycle 1, treatment was initiated
pegfilgrastim use in the first and subsequent cycles to support > 10 days after chemotherapy in 49% of patients versus 6%
dose-dense chemotherapy for breast cancer in patients > of pegfilgrastim patients. Filgrastim patients experienced more
60 years. METHODS: Patients > 60 years with ESBC treated neutropenia-related complications. CONCLUSIONS: Patients
over a 2-year period with dose-dense adjuvant chemotherapy receiving pegfilgrastim were more likely to receive growth factor
(doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every within 72 hours of chemotherapy and had a lower incidence
2 weeks followed by paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 of neutropenia-related complications compared with patients
every 2 weeks) and pegfilgrastim (6 mg/cycle) were identified receiving filgrastim.
by chart review. RDI, treatment delays, neutropenic fevers,
and other toxicities were assessed. RESULTS: Fifteen patients NEUTROPENIA-RELATED PEGFILGRASTIM FILGRASTIM
COMPLICATIONS (% [95% CL]) (n = 1,922) (n = 829) P VALUE
were evaluated. Median (range) age was 66 (60–78) years, and
Febrile neutropenia 6% (5, 7) 10% (8, 12) 0.0004
all patients had a performance status of 1. In total, 119 of 120
Hospitalization for 4% (3, 4) 6% (4, 8) 0.01
planned chemotherapy cycles were administered (one withheld febrile neutropenia
due to peripheral neuropathy), and RDI was 94.8%. Dose delays Anti-infective treatment 24% (22, 26) 32% (29, 35) < 0.0001
occurred in 2 patients (1 pneumonia, 1 peripheral neuropathy). for infection
Four patients had four episodes of neutropenic fever over 119 CL = confidence limits
cycles (3.4%). These patients subsequently received antibiotic
prophylaxis without reoccurrence. Anemia (hemoglobin level
< 11 g/dL) occurred in 12 patients, all requiring erythropoietin
support. Other toxicities included nausea and vomiting, hand
and foot syndrome (docetaxel), peripheral neuropathy, bone
pain, facial cellulitis, mucositis, pneumonia, and headaches.
CONCLUSIONS: In this small case study, patients > 60 years with
ESBC were successfully administered dose-dense adjuvant
chemotherapy with pegfilgrastim support.

VOLUME 3, NUMBER 5, SUPPLEMENT 3 ■ SEPTEMBER/OCTOBER 2005 www.SupportiveOncology.net 29


2005 Chicago Supportive Oncology Conference

Abstract PA-21 are due to neutropenic events, mostly occurring in cycle 1. The
Pegfilgrastim in All Cycles Reduces ANC Registry documented cycle 1 febrile neutropenia rates of
Chemotherapy-Induced Neutropenia in Older 8% in patients receiving chemotherapy with community colony-
Patients stimulating factor support. This community-based study in cancer
patients receiving myelosuppressive chemotherapy evaluates the
W. Ershler1, T. Pluard2, N. Angel3, S. Shahin4, J. Green4,
R. Dansey4, L. Balducci5 impact of first-and-subsequent cycle pegfilgrastim on neutropenic
events. METHODS: This open-label, single-arm study enrolled 2,252
1
Institute for Advanced Studies in Aging, Washington, DC;
adult patients (319 sites) with cancers other than leukemia or
2
Missouri Cancer Care PC, Saint Charles, Missouri; 3Oncology
Center at Providence Park, Mobile, Alabama; 4Amgen Inc., myelodysplastic syndrome patients, including patients with major
Thousand Oaks, California; 5Moffitt Cancer Center and comorbid illnesses not generally eligible for clinical trials. Patients
Research Institute, Tampa, Florida received pegfilgrastim 6 mg about 24 hours post chemotherapy
in each cycle. Endpoints include neutropenic complications and
BACKGROUND: Chemotherapy-induced neutropenia is common in chemotherapy dose reductions and delays. Point estimates (95%
older patients. As a result, older patients often receive reduced- confidence limits (CL]) are provided. RESULTS: First-cycle data from
dose chemotherapy, limiting effectiveness. This study evaluated 874 patients (201 sites) are available. In all, 76% of patients were
first-cycle pegfilgrastim in reducing neutropenic complications women, and most had breast cancer (51%). The mean (SD) age
of chemotherapy among older patients. METHODS: Patients ≥ was 58.6 (12.9), 48% of patients had early-stage (I–II) disease, 21%
65 years old receiving chemotherapy for lung, breast, or ovarian received prior chemotherapy, 15% received prior radiotherapy,
cancer or non-Hodgkin’s lymphoma (NHL) were randomized to and 26% had significant comorbidities. See table for neutropenia-
receive either pegfilgrastim 6 mg in all cycles or no pegfilgrastim related events. Serious adverse events were consistent with those
in cycle 1 with subsequent use determined by physician. Results observed in patients receiving myelosuppressive chemotherapy.
are presented only for solid tumors. RESULTS: In total, 686 patients CONCLUSIONS: Community-practice patients receiving first-
were included in the primary analysis set, 343 per treatment group. and-subsequent cycle pegfilgrastim and myelosuppressive
Median age was 72 years (range, 65–88); 66% were female. The chemotherapy experienced few neutropenic complications and
most commonly administered chemotherapies were carboplatin alterations in chemotherapy dose and schedule.
with paclitaxel (36%), etoposide (15%) or docetaxel (12%), and
INCIDENCE (95% CL)
doxorubicin with cyclophosphamide (15%). In the physician NEUTROPENIA-RELATED EVENTS (n=874)
discretion arm, 42% of patients received pegfilgrastim, most often Cycle 1 febrile neutropenia 2% (1%, 4%)
due to grade 3/4 neutropenia in a previous cycle (62%). Overall Cycle 1 neutropenia-related IV antibiotics use 2% (1%, 3%)
incidence of febrile neutropenia (absolute neutrophil count < Cycle 1 neutropenic hospitalizations 2% (1%, 3%)
1,000/µL and temperature ≥ 38°C) was significantly lower for Cycle 2 reported dose reductions (all reasons) 6% (5%, 8%)
patients receiving pegfilgrastim in all cycles (4%) than for those Neutropenia-related dose reductions 2% (1%, 3%)
receiving no pegfilgrastim in cycle 1 (10%; P = 0.0014). Patients Cycle 2 reported dose delays (all reasons) 5% (4%, 7%)
receiving pegfilgrastim in all cycles had a lower incidence of grade Neutropenia-related dose delays < 1% (0%, 1%)
3/4 neutropenia (30% vs 80%), chemotherapy dose reduction
(7% vs 14%), hospitalization for neutropenia-related events (5%
vs 9%), anti-infective use (12% vs 29%), and serious adverse
events (26% vs 35%) compared with patients in the other group.
CONCLUSIONS: Pegfilgrastim used from the first chemotherapy Abstract PA-23
cycle onward offered patients advantages in terms of reducing Neutropenia and Anxiety in Advanced Non-
neutropenic complications, thus improving clinical outcomes. Small Cell Lung Cancer (NSCLC) Patients:
Initial Report of a Randomized, Controlled,
Pilot Trial Using Pegfilgrastim to Reduce
Neutropenia Complications
Abstract PA-22 F. Smith1, L. Wagner2, M. Kandahari3, S. Shahin3, J. Malin3,
Impact of First and Subsequent Cycle R. Dansey3, J. Crawford4
Pegfilgrastim on Neutropenic Events in 1
Sibley Memorial Hospital, Washington, DC; 2Northwestern
Patients Receiving Myelosuppressive University, Feinberg School of Medicine, Chicago, Illinois;
Chemotherapy: Preliminary Results of FIRST, a 3
Fairfax Hospital Cancer Center, Fairfax, Virginia; 3Amgen,
Prospective Community-Based Study Thousand Oaks, California; 4Duke University Medical Center,
Durham, North Carolina
Howard Ozer1, Beiying Ding2, Roger Dansey2
1
University of Oklahoma Cancer Center, Oklahoma City; BACKGROUND: Potential chemotherapy side effects may adversely
2
Amgen Inc., Thousand Oaks, California
impact patients’ physical, social, and mental well-being
BACKGROUND: Most alterations to chemotherapy dose and schedule (eg, anxiety). This study evaluated the association between

30 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

chemotherapy-induced neutropenia and quality-of-life changes life-years was calculated by transforming QOL data (Functional
using the Hospital Anxiety and Depression Scale (HADS) and Assessment of Cancer Therapy-General [FACT-G]) responses to
other measures. METHODS: Stage IIIB/IV NSCLC patients receiving utilities using an algorithm derived from cancer patients. RESULTS:
carboplatin AUC 5/6 with paclitaxel 175–225 mg/m2 or docetaxel Based on 67 patients with complete FACT-G and BMI at baseline
75 mg/m2 randomized to first-and-subsequent-cycle pegfilgrastim and 2 months, oxandrolone resulted in a net cost savings of $895
or no pegfilgrastim in cycle 1 with subsequent cycle use according per patient and an improvement in the FACT-G based mean
to physician discretion. Complete blood counts and HADS were utility score of 0.034 ± 0.09 (P = 0.008) versus no treatment.
administered on day 1 of cycles 1 to 3, and at expected cycle 1 CONCLUSIONS: Oxandrolone was a dominant strategy resulting in
and 2 ANC nadir. Endpoints included neutropenia incidence cost savings and gains in health-related QOL after more than
and change in HADS-anxiety (HADS-A) subscale (ranging 2 months versus no treatment. Sensitivity analysis resulted in
from 0 [not anxious] to 21 [most anxious]). RESULTS: In all, 149 an incremental cost-utility ratio for oxandrolone of $3,427
patients were treated, mean (SD) age 65.0 (11.4), 60% male, 52% per quality adjusted life month within 2 months of treatment,
carboplatin-paclitaxel. Grade 3/4 neutropenia incidence (95% becoming a dominant strategy from 3 months onwards, with net
CL) in cycles 1 and 2 was 5% (2%, 13%) for patients receiving cost savings averaging $606 per patient per month.
first-and-subsequent-cycle pegfilgrastim and 43% (31%, 55%)
for patients receiving physician-discretion pegfilgrastim. Over
70% of patients completed all HADS-A items at each timepoint.
Exploratory analyses of HADS-A change scores from baseline Abstract PA-25
to end of cycle 1 and 2 are presented in the table. CONCLUSIONS: A Pilot Limited Institutional Study to Evaluate
Neutropenia was markedly reduced, and initial analysis suggested the Safety and Tolerability of Immunocal,
anxiety may have been reduced for patients receiving first-and- a Nutraceutical Cysteine Delivery Agent in
subsequent-cycle pegfilgrastim. the Management of Wasting in High-Risk
FIRST-CYCLE
Childhood Cancer Patients
PEGFILGRASTIM PHYSICIAN DISCRETION
Steven J. Melnick1, Paul Rogers2, Nancy Sacks3, Thomas A.
Mean (95% CL) HADS-A 7.15 (5.88, 8.42) 7.02 (6.05, 7.98) Kwyer4, Jacqueline Halton5, Eric Sandler6, Enrique Escalon7,
cycle 1 baseline n = 59 n = 65
Elena J. Ladas8
HADS-A mean change (95% CL) from cycle 1 baseline to end of:
Cycle 1 –1.69 (–2.81, –0.58) –0.40 (–1.17, 0.37)
1
Department of Pathology and Laboratories, Miami Children’s
n = 59 n = 65 Hospital. Miami, Florida; 2Division of Paediatric Haematology/
Cycle 2 –1.65 (–2.88, –0.43) –0.34 (–1.32, 0.64) Oncology & Bone Marrow Transplantation, C&W Hospital
n = 55 n = 50 and University of BC, Vancouver, British Columbia, Canada;
HADS = Hospital Anxiety and Depression Scale; CL = confidence limits
3
Division of Oncology, Children’s Hospital of Philadelphia,
Philadelphia, Pennsylvania; 4Division of Otolaryngology,
Department of Surgery, Medical University of Ohio, Toledo,
5
Children’s Hospital of Eastern Ontario, Ottawa, Ontario,
Canada; 6Nemours Children’s Clinic-Jacksonville Hematology/
Involuntary Weight Loss Oncology; Jacksonville, Florida; 7Division of Hematology/
Oncology, Miami Children’s Hospital, Miami, Florida;
Abstract PA-24
8
Integrative Therapies Program for Children with Cancer,
Cost-Utility Analysis: Oxandrolone Versus No Columbia University, New York, New York
Treatment for Cancer-Related Weight Loss B ACKGROUND : This pilot study, conducted through the
Hind T. Hatoum , A. Simon Pickard
1,2 2 Nutrition subcommittee of the Children’s Oncology Group
1
Hind T. Hatoum & Company, Chicago, Illinois; 2University of (COG), evaluated the safety and tolerability of Immunocal, an
Illinois, College of Pharmacy, Chicago undenatured whey-protein derivative that provides glutathione
precursors. Depletion of reduced glutathione (GSH) in various
BACKGROUND: Cancer-related involuntary weight loss (IWL) organs including the immune system is a common finding in
adversely impacts cancer outcomes and quality of life (QOL). cachexia, reduced immune function, and poor wound healing,
Studies have demonstrated oxandrolone to be effective, which are among the serious consequences cancer patients
resulting in improved weight and QOL scores and associated endure due to their disease and/or therapy. The study was a
cost savings. We performed a cost-utility analysis of oxandrolone 90-day, two-dose evaluation of Immunocal (0.5 g/kg vs 1.0
treatment versus no treatment in cancer-related IWL from a g/kg) added to the standard institutional nutritional regimen.
payer perspective. METHODS: Data from an open-label trial of METHODS: Twelve patients with high-risk solid tumors were
oxandrolone 10 mg twice daily in cancer patients were used. Direct enrolled from three institutions. Clinical and biochemical
medical care costs were derived from predicted hospitalization data were assessed at baseline and on days 45 and 90. RESULTS:
and discharge to long term care based on body mass index (BMI) Immunocal was successfully administered by one or more of
change. Incremental cost-effectiveness using quality adjusted three routes (oral, gastric tube, and nasogastric tube) and was

VOLUME 3, NUMBER 5, SUPPLEMENT 3 ■ SEPTEMBER/OCTOBER 2005 www.SupportiveOncology.net 31


2005 Chicago Supportive Oncology Conference

generally well tolerated. Compliance ranged from 55%–100% anorexia must a) compensate for the loss of the unconscious
(7 patients with > 88%). All but 2 patients gained weight impetus to eat and b) acknowledge that patients physically
ranging from 7.3%–26.9% from the prestudy weight. Though capable of oral intake can nevertheless experience an absolute
not statistically significant, GSH levels increased in 83% of inability to eat.
patients, whereas oxidized glutathione levels decreased in
83%. Other observations include the amelioration of severe
mucositis in 2 patients and abatement of nausea and vomiting
in 2 patients. CONCLUSIONS: The findings indicated Immunocal
could be given safely and was well tolerated in the majority of Quality Care
pediatric cancer patients. The results are being used to establish Abstract PA-27
end-points for a double-blind placebo controlled trial to be
Psychosocial Outcomes of Prostate Cancer
submitted to the COG scientific committee to evaluate of the
Survivors on Androgen-Deprivation Therapy
efficacy of Immunocal in high-risk cancer patients.
Sylvie Aubin
Department of Psychiatry and Behavioral Medicine, University of
Washington, Seattle
Abstract PA-26
Psychosocial and Dietary Management of B ACKGROUND : Prostate cancer is the most common solid
Anorexia by Patients with Advanced Cancer tumor in men. Following primary therapy, more than 20% of
men experience a biochemical relapse. Androgen-deprivation
Jeremy E. Shragge1,2, Kärin Olson2, Wendy Wismer1,
therapy (ADT) is commonly used to treat biochemical relapse
Vickie Baracos3
but significantly affects quality of life (QOL). Research has
1
Department of Agricultural, Food and Nutritional Sciences, investigated the physical effects of ADT extensively, yet minimal
2
International Institute for Qualitative Methodology, and
studies examine psychosocial effects of ADT. This study evaluated
3
Department of Oncology, University of Alberta, Edmonton,
Alberta, Canada. the impact of intermittent use of ADT on QOL domains of
physical stamina/vitality and sexual function. Participants (n
BACKGROUND: Anorexia (loss of appetite) figures prominently = 32) with biochemical relapse and no evidence of metastases
in the numerous stresses and losses that cancer patients face were treated with leuprolide and flutamide on an intermittent
near the end of life. Malnutrition attendant to anorexia may basis of 9 months of followed by an “off” period. METHODS:
undermine tolerance to treatment, strain patient-family Self-report questionnaires included the Southwest Oncology
relationships, and hasten patient death. The primary objective of Group Intermittent Androgen Suppression Quality of Life
this qualitative study was the creation of a theoretic framework Questionnaire administered prior to ADT and after 9 months of
that would integrate the strategies used by patients to manage treatment. RESULTS: The median age was 66 years (range, 51–71).
the dietary and psychosocial consequences of anorexia. Results showed significant pre- to post-ADT decrease in physical
METHODS: Grounded Theory methodology was employed to stamina/vitality. Men reported feeling more worn out and tired.
guide and analyze tape-recorded, open-ended interviews with In addition, results showed an increase in the number of men
anorectic patients with advanced cancer (n = 9). RESULTS: We reporting a lack of sexual activities, decreased sexual desire,
discovered that preparation and consumption of meals lost most and worsening of their overall sexual function. CONCLUSIONS:
of their pleasurable qualities for patients. In addition, patients Significant results stressed the importance of assessing changes
craved specific foods rarely, experienced little spontaneous in stamina, fatigue, and sexuality of men treated with ADT.
food ideation, and suffered varying degrees of early satiety. The Results also suggested the need to assess non-functional aspects
unconscious impetus to eat (hunger) was greatly diminished if of sexuality, such as intimacy, to determine if it also is negatively
not totally lost. Whereas anorexia was not in itself necessarily impacted by ADT. The study results improved our knowledge of
distressful to patients, its logical, long-term consequences (ie, the effects of ADT on QOL and may help design interventions
weakness and starvation) were. “Establishing control” over both to address side effects.
the impetus to eat and the maintenance of adequate caloric
intake emerged as the core category. Despite appetite loss,
patients would often attempt food by resolving that they “had to
eat” in order to survive. When the conscious impetus to eat (“I
have to eat”) was overridden by the compelling desire to avoid
nausea and emesis (“I just can’t eat”), patients often were left
feeling conflicted and frustrated. In some instances, however,
patients were content with small meals that did not precipitate
distressing physical symptoms. C ONCLUSIONS : Nutritional
interventions developed to ameliorate the consequences of

32 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY


Poster Abstracts

Abstract PA-28 compares PCM1.0 with a new expanded version, PCM2.0, and
The Use and Delivery of Emergency Drug Kits with a structured interview by expert oncology nurse. METHODS:
(EDKs) at the Birmingham VA Medical Center: A Cancer patients (n = 75) completed PCM1.0 and PCM2.0 in
Multidisciplinary Quality Improvement Project counterbalanced order and also were interviewed by one of three
Using the Plan-Do-Study-Act (PDSA) Cycle expert oncology nurses. Validity was examined at the item level
using nursing interview results as the gold standard. Problems
Joseph T. Chan1,2, Heather D. Au1, J. Andrew Carr1, James T.
Coleman1, Debra Cook-Rice1,and Frank Amos Bailey1,2 were judged as being either present or absent and, if present,
were rated for severity on a 0–10 severity scale. Interjudge
1
Birmingham VA Medical Center, Birmingham, Alabama;
reliability between nursing interviewers was established for 30
2
University of Alabama at Birmingham Center for Palliative
Care, Birmingham cases using tape recordings of interviews. Item correlations and
paired t test were used to assess comparability of rated severity.
BACKGROUND: The Birmingham VA Medical Center’s Palliative Kappa was used to assess agreement for presence/absence
Care Service provides an emergency drug kit (EDK) to veterans of any single problem at the item level. Receiver operating
enrolled in hospice to alleviate anticipated terminal symptoms. characteristics (ROC) analysis was computed for all 87 items
The EDK contains lorazepam, morphine sulfate, promethazine, and related statistics were reported.
scopolamine, furosemide, haloperidol and gatifloxacin. Prescription
adherence to an EDK including morphine sulfate and the
complete delivery of the EDK have not been consistent, which
is a barrier to symptom control at the end of life. We evaluated Abstract PA-30
the effectiveness of a multidisciplinary intervention based on Patient-Reported Symptom Complaints
the following outcome measures: (a) provider adherence to Associated with 5-Fluorouracil (5-FU) +
an EDK prescription; (b) inclusion of morphine sulfate, and Irinotecan (IRI) or Oxaliplatin (OXALI) in
(c) complete delivery of the EDK. METHODS: This is a pre-post Colorectal Cancer (CRC)
intervention trial based on a Plan-Do-Study-Act (PDSA) cycle.
Barry Fortner1, Kimary Kulig2, Ling Zhu1, Samuel Wagner2,
The intervention involved strategies from medical, information Johnetta Blakely3, Lee Schwartzberg3
technology, nursing, and pharmacy disciplines. Before- and after- 1
Accelerated Community Oncology Research Network, Memphis,
implementation outcome measures data were abstracted from
Tennessee; 2Pfizer Outcomes Research, New York, New York,
the medical records of deceased veterans enrolled in hospice. 3
The West Clinic, Memphis, Tennessee
Monthly results will be tracked on a run chart for 6–12 months
and statistically analyzed. PRELIMINARY RESULTS: Pre-intervention BACKGROUND: Although toxicities have been documented in
records of deceased veterans were reviewed from January to March CRC clinical trials, less has been done to explore patient-reported
2003. Of the 36 veterans, 83% were prescribed an EDK, only severity of these same toxicities in actual clinical practice.
67% of which included morphine sulfate. EDKs were completely Medicare’s recent emphasis on quality of supportive care further
delivered 65% of the time. Post-intervention outcome measures highlights the need to understand and treat these symptoms.
for the past 4 months have shown an upward trend, approaching This study describes results of preliminary analyses in CRC
100% for the month of July. CONCLUSIONS: A multidisciplinary chemotherapy patients through use of a validated patient report
quality improvement project based on a PDSA cycle can be an tool. METHODS: A database generated from two large community
effective intervention to the use and delivery of EDKs. oncology practices was accessed, and CRC patients who

5-FU + OXALI 5-FU + IRI


MODERATE SEVERE MODERATE SEVERE
SYMPTOM n (%) n (%) n (%) n (%)
Abstract PA-29 Fatigue, tiredness, or 43 (38.05) 38 (33.63) 18 (31.58) 9 (15.79)
Item Validation of Patient Care Monitor weakness
Version 2 (PCM2.0) Using Nursing Interview Rash or dry skin or 28 (24.78) 10 (8.85) 9 (15.79) 2 (3.51)
and PCM1.0 itching
Daytime sleepiness 34 (30.09) 15 (13.27) 10 (17.54) 6 (10.53)
Barry V. Fortner, Lee S. Schwartzberg, Arthur C. Houts Physical pain 30 (26.55) 24 (21.24) 12 (21.05) 9 (15.79)
Supportive Oncology Services, Memphis, Tennessee; The West Nausea or vomiting 28 (24.78) 21 (18.58) 15 (26.32) 5 (8.77)
Clinic, Memphis Tennessee Trouble w/ diarrhea 33 (29.20) 28 (24.78) 17 (29.82) 13 (22.81)
or constipation
BACKGROUND: The PCM1.0 assessment system brought state-of- Trouble sleeping 42 (37.17) 23 (20.35) 13 (22.81) 9 (15.79)
the-art technology to assessing cancer patients in community Numbness or tingling 35 (30.97) 21 (18.58) 9 (15.79) 4 (7.02)
oncology, where over 80% of all cancer patients in the United Burning in hands or 24 (21.24) 7 (6.19) 4 (7.02) 2 (3.51)
States are assessed and treated. PCM1.0 is a psychometrically feet
reliable and valid measure of patient symptoms, functioning, and Fever or chills 15 (13.27) 7 (6.19) 5 (8.77) 1 (1.75)
QOL. The system is tablet-computer based. This investigation

VOLUME 3, NUMBER 5, SUPPLEMENT 3 ■ SEPTEMBER/OCTOBER 2005 www.SupportiveOncology.net 33


2005 Chicago Supportive Oncology Conference

completed at least one Cancer Care Monitor (CCM), a patient to change in PSR (P = 0.001 and 0.003, respectively) at 6 weeks.
report measure including 38 physical cancer-related symptoms, CONCLUSIONS: Based on distribution- and anchor-based methods,
were eligible. CCM scores reported within 28 days of a 5-FU + minimally important differences were estimated as 5–7 points for
IRI or OXALI administration between 8/1/03 and 7/31/04 were the BrS and 3–4 points for the FBrSI. The BrS and FBrSI may
selected. Patients indicated severity on an 11-point Likert scale (0 be useful endpoints in the assessment of therapies for recurrent
= No problem; 1–3 = Mild; 4–6 = Moderate; 7–9 = Severe; 10 high-grade glioma.
= As bad as possible). RESULTS: In all, 57 IRI patients (mean age,
57 years; male = 63%) and 113 OXALI patients (mean age, 58
years; male = 50%) contributed 9 and 10 CCM administrations
per patient, respectively. Frequencies of selected symptoms are in Abstract PA-32
the table. CONCLUSIONS: A wide range of high-severity symptoms The Life Tape Project, An Existential
were reported at even greater frequencies than in clinical trials Intervention for Cancer Patients: A Progress
relying on clinician-rated toxicity. A patient self-report tool is Report
valuable for longitudinal assessment of frequency and severity of
Ernest Rosenbaum1, Robert W. Garlan2, Alison L. Siegel3, Shelly
symptoms and can emphasize the need for quality supportive care. Henderson4, Naama Hirschberger5, Lisa D. Butler6, David
Our ongoing study will delineate treatment-specific differences Spiegel6
in symptom reporting. 1
Department of Medical Oncology and the Comprehensive
Cancer Center, University of California, San Francisco;
2
Private Practice, San Jose, California; 3Breast Cancer Clinic
and Resource Center, University of California, San Francisco;
Abstract PA-31 4
Pacific Graduate School of Psychology, Palo Alto, California;
Validation of the Functional Assessment of The Sharett Institute of Oncology, Hadassah University
Cancer Therapy-Brain (FACT-Br) Questionnaire Medical Center, Jerusalem, Israel; 6Department of Psychiatry &
and FACT-Br Symptom Index (FBrSI) in Behavioral Sciences, Stanford University School of Medicine,
Patients with Recurrent High-Grade Gliomas Stanford, California;

Angel Nickolov1, Jennifer L. Beaumont1, David Victorson1, Amy


BACKGROUND: Confronting cancer, most patients struggle with
H. Peterman2, David Cella1, Astra M. Liepa3, Howard A. Fine4
their mortality and threats to their emotional equilibrium and
1
Center for Outcomes, Research and Education (CORE), that of their families. Families may become closer, but, frequently,
Evanston Northwestern Healthcare, Evanston, Illinois;
communication difficulties and isolation increase. The Life Tapes
2
University of North Carolina, Charlotte, North Carolina; 3Eli
Lilly and Company, Indianapolis, Indiana; 4 Neuro-Oncology Project (LTP) is an intervention involving a 2-hour video-recorded
Branch, National Cancer Institute, National Institutes of Health, life history, that is designed to help patients and their families
Bethesda, Maryland confront this existential crisis. Previous observation and pilot data
suggest that patients receive substantial benefits from participation.
BACKGROUND: The Functional Assessment of Cancer Therapy- Preliminary results from a new study, designed to quantify and
Brain (FACT-Br) has been validated previously in a mixed sample extend these observations, are reported. METHODS: Patients
of patients with diagnosis of primary brain tumors. The FACT-Br completed baseline questionnaires before the LTP interview and
Symptom Index (FBrSI) was later developed in coordination with follow-up packets 2 and 10 weeks after. Measures included, among
the National Comprehensive Cancer Network through interviews others, the FACT-G for Quality of Life (QOL) and a measure of
with expert providers to determine the most important symptom perceived benefits of participation covering eight themes suggested
targets when treating advanced cancer. METHODS: The FACT-Br, by previous research. A final semistructured interview probed
including FBrSI, was administered to patients with recurrent high- possible unwanted effects. RESULTS: The results for the first follow-
grade gliomas participating in a phase II trial of enzastaurin for up (n = 23 to date) indicated that QOL improved significantly,
the purpose of validating the questionnaire in this population. It and substantial benefits (endorsing “very” or “extremely true
was administered prior to start of therapy, at 3 weeks, at 6 weeks, for me”) were reported by a majority of participants. The most
and then every 6 weeks thereafter while on therapy. RESULTS: frequently endorsed items related to themes of Imparting Personal
In this preliminary sample, 71% of patients had a diagnosis of Philosophy (74% of participants), Reducing Existential Dread
glioblastoma multiforme and 70% had a Karnofsky performance (70%), Gaining Perspective and Meaning (65%), and Improved
status rating (PSR) of ≥ 90% at baseline. The FACT-Br data Communication (57%). Final interviews revealed no unwanted
were available for 82 patients at baseline, 65 at 3 weeks and 45 effects. CONCLUSIONS: The LTP provideda powerful, safe, and
at 6 weeks. The 23-item Brain Subscale (BrS) and 15-item FBrSI accessible intervention that can improve family communication
demonstrated good internal consistency with Cronbach’s alphas and connectedness, promote personal growth, and reduce
at the three assessments of 0.85–0.88 and 0.76–0.86, respectively. existential anxiety through the creation of “symbolic immortality.”
Both scales differentiated patients by PSR at all assessments (all P Requiring minimal equipment and time, the LTP would make an
< 0.05). The BrS and FBrSI both demonstrated responsiveness excellent addition to any supportive care program.

34 www.SupportiveOncology.net THE JOURNAL OF SUPPORTIVE ONCOLOGY