PICO

Chemotherapy And
Radiotherapy for Advanced
Cervical Cancer
Achmadi Sulistyo Nugroho

1st Journal

A Randomized Trial of Standard versus Partially

Hyperfractionated Radiation with or without Concurrent 5Fluorouracil in Locally Advanced Cervical Cancer
GYNECOLOGIC ONCOLOGY 69, 137145

O Objective : determine whether the addition of

concurrent 5-fluorouracil (5-FU) and/or a change

in radiation fractionation improves pelvic control
and survival or decreases complications in
advanced cervical cancer, FIGO stages IB/IIA (5
cm) to IVA inclusive.

Material and Methods

Time : January 2008 December 2010

Subject

Patient selection internal database

Patient criteria received one previous
chemotherapy line for the treatment of incurable
disease
:
Data collection retrospectively collected
Sample size : 21 patients

Material and Methods

Stratum 2
1 included
: those with
those
FIGO
with
stage
FIGO
IB/IIA
stage
orIIB
stage
disease
IIB with
with any late

Intervention

A
A variety
variety of
of topotecan
topotecan
schedules
were
schedules were prescribed
prescribed

0.75
0.75 mg/m2
mg/m2 per
per day
day
during
during 5
5 consecutive
consecutive days
days
to
to 2.0
2.0 mg/m2
mg/m2 per
per day
day
during
during 3
3 consecutive
consecutive days
days

Every
Every 21
21 days
days or
or weekly
weekly
topotecan
topotecan at
at 3.0
3.0 mg/m2
mg/m2
administered
administered at
at days
days 1,
1, 8
8
and
and 15
15 on
on 28-day
28-day cycles
cycles

Premedication
and
Premedication
and
discharge
prescription
discharge
prescription
were
were in
in accordance
accordance to
to the
the
guidelines
of
the
guidelines
of
the
Institution
Institution

Regimen
Regimen selection,
selection, dose
dose
adjustments
and
delays
adjustments and delays in
in
subsequent
subsequent cycles
cycles
by
by
the
the assistant
assistant physician,
physician,
according
to
clinical
according
to
clinical
evaluation
and
presented
evaluation and presented
toxicities.e
toxicities.e

History,
physical
History,
physical
examination
and
examination
and
laboratory
evaluations
laboratory
evaluations
were
were obtained
obtained prior
prior to
to
each
treatment
cycle.
each treatment cycle.

Outcome

Conclusion
Topotecan,
Topotecan, as
as a
a single
single agent
agent or
or in
in combination,
combination, exihibits
exihibits only
only modest
modest
activity
activity in
in a
a population
population of
of previously
previously treated
treated patients
patients with
with cervical
cervical
cancer
cancer albeit
albeit at
at a
a cost
cost of
of substantial
substantial hematologic
hematologic toxicity
toxicity

The
The limited
limited activity
activity of
of topotecan
topotecan schemas
schemas in
in secondsecond- line
line
treatment
of
cervical
cancer
and
the
associated
overtreatment of cervical cancer and the associated over- all
all toxicity
toxicity
as
shown
in
this
retrospective
study
may
not
justify
their
as shown in this retrospective study may not justify their use
use in
in
this
setting.
this setting.

Patients
Patients who
who progress
progress after
after first-line
first-line
participation
in
clinical
participation in clini- cal trials,
trials, other
other
supportive
care
measures.
supportive care measures.

treatment
treatment may
may be
be
second-line
second-line agents
agents

offered
offered
or
or best
best

2nd Journal
European Journal of Cancer 39 (2003) 24702486

Objective
Primary
the proportion of patients with progression free survival (PFS)
for at least 6 months and the frequency and severity of
adverse events

Secondary
to estimate the probability of clinical response, the
distribution of overall survival (OS), the distribution of
PFS, and the impact of potential prognostic factors on PFS
or OS.

Material and Methods

Methods

Time : April 2002 November 2006

Sample size : 50 patients

The study received local institutional review board

approval at participating institutions, and all patients
gave informed consent according to institutional and
federal guidelines before enrollment.

Material and Methods

Up-to-date information on the date of

Outcome
comparison 1

11
patients
progression
free for at least
6 months

comparison 2

5 patients
partial
respones

PFS 3.4 months

Median time
respons 6.21
months

Overall
survivor times
7.29 months

Implication
O There are two alternative neoadjuvant strategies to improve

long-term outcomes. One is a short cycle, dose intensive course

of cisplatin-based chemotherapy prior to radiotherapy. The
second is similar chemotherapy given prior to surgery (with or
without radiotherapy),

O Kesimpulan
O Pemberian NAC sebelum dilakukan

operasi memberikan manfaat yang lebih

besar daripada jika dilakukan operasi
tanpa NAC dulu atau hanya diberikan
radiasi saja.

Thank you