(jean-philippe.metges@chu-brest.

fr)
Fonction All patients
de survie Patients
Fonctions de survie > 70 or < Fonctions
70 yearsde survie
1,1 1,1 1,2

Progression free survival

Progression free survival

Progression free survival

1,0 1,0
1,0 Age
> 70 years

during treatment
,9 ,9

,8
,8 ,8
Age
Age
Age
,7 ,7 ,6
< 70 years
plus de 70 ans plus de 70 ans

In a phase III pivotal trial in patients with UMCC, BEVACIZUMAB ,6 ,6 plus de 70 ans
Su ,4 plus de 70 ans

Survie cumulée

Survie cumulée
-censuré
rvi -censuré
,5 ,5
e

increased overall survival (OS) by 30% when added to first-line IFL

moins de 70 ans moins de 70 ans
cu ,2
,4 Fonction de
,4 survie
m de 70 ans
moins moins de 70 ans

 61% M - 39% F ,3 Censuré ,3 ulé 0,0

-censuré -censuré

chemotherapy (CT). Due to higher incidence of side effects, IFL switched

0 10 20 30 0 10 20 30 0 10 20 30

Months Months Months

 Mean age : 61 years [43-83] IC 95% [59-62]
Temps jusqu'à progression (en mois) Temps jusqu'à progression Temps jusqu'à progression avastan

to FOLFIRI (IFL equivalent European schedule). Very scarce prospective The median of progression free survival is 15,4 months IC 95%
20% of the patients were > 70 years
data are focused on FOLFIRI BEVACIZUMAB in first line UMCC especially [11,09 - 19,71]. We observe a significant difference (p < 0,05) between
concerning ederly patients with age more than 70 years.
 36% of patients had had adjuvant chemotherapy
patients > 70 (13,38 months) or < 70 years (18,6 months) for progres-
Patients Patients sion during BEVACIZUMAB.
All patients
< 70 years > 70 years

How to answer the question : FOLFIRI BEVACIZUMAB, what results ? Number 125 100 25
Fonction deAll patients
survie Patientsde>
Fonctions 70 or < 70 years
survie

Use DATABASE from OMIT :

1,1 1,1

Objective response rate % (nb) 33% (41) 34% (34) 28% (7) 1,0 1,0

 Created in 2003 by Regional representatives of French Ministery ,9 ,9

Overall survival
Age

Overall survival
,8 ,8 > 70 years
of Health Stable disease % (nb) 18% (23) 18% (18) 20% (5) ,7 ,7
Age

plus de 70 ans

 Collectiong data from both private and public hospitals ,6 ,6 Age

plus de 70 ans

Survie cumulée
Survie cumulée
< 70 years
-censuré
,5 ,5

 Developping discussion about clinical practice Progressive disease % (nb) 33% (41) 32% (32) 36% (9) ,4 Fonction de survie ,4
moins de 70 ans

moins de 70 ans

 Data patients treated with FOLFIRI BEVACIZUMAB

,3 Censuré ,3 -censuré
0 10 20 30 40 0 20 40 60 80 100

Stop treatment because Durée de survie (en mois)Months Durée de survie (en mois)Months
16% (20) 16% (16) 16% (4)
side effects
The median of overall survival is 29 months IC 95% [23,84 - 33,89].
We observe a difference between patients > 70 or < 70 years but isn’t
Evaluate efficacy and tolerance of this regimen in a cohort of non Resecability liver metastasis 25% (32) 28% (28) 16% (4) statistically significant (p > 0,05).
selected patients in usual clinical practice : Concerning the whole cohort, the 6 months-overall survival rate is 91%,
 % objective response Resecability other metastasis 6% (7) 7% (7) 0 the 18 months-overall survival rate is 62%.
 Resecability
 Tolerance: side effects, hypertension, bleeding, adaptations
doses  30% continued FOLFIRI or FOLFOX BEVACIZUMAB and 7% Folfiri alone
 Survival and 2nd line treatment  8 gastrointestinal toxicities  4 occlusions Second line :
(diarrhea, pain)  1 thrombosis  21% : had no second line (remission, toxicity, stable disease, death)
 1 ischemic stroke  1 phlebitis  30% : cetuximab irinotecan/Folfiri
 1 thrombopenia  1 faint  14% : Folfox
 125 patients treated in 2006
 1 anaphylactic stroke  1 dyspnea  2% : radiotherapy
 Metastatic colorectal cancer in first line therapy
 1 epistaxis and rectal bleeding  3% : capecitabin based regimen
 Same protocol for all patients : BEVACIZUMAB : 5mg/kg biweekly
 Association with so-called FOLFIRI regimen :
irinotecan : 180 mg/m² biweekly + 5-FU : 400 mg/m² (bolus) Acknowledgments We present here the results from the french OMIT database concerning the
For Private and public hospitals in Bretagne and Pays de la Loire: use of Folfiri bevacizumab. This schedule is clearly feasible in non selected
and 2400 mg/m² (infusion 46h) + folic acid : 400 mg/m²
For clinicians, pharmacists, Directors
 45 private and public hospitals CHU Brest, CH La Roche, Clinique Pasteur Brest, CLCC René Gauducheau Nantes, CLCC patients and especially in ederly patients. For all patients, there is a high
Paul Papin Angers, Clinique Océane Vannes, Centre Catherine Sienne Nantes, Clinique
 Criteria for initial unresectability of metastatic lesions was based rate of resection in UMCC in usual practice with a good response rate and
Armoricaine de Radiologie St Brieuc, Centre Jean Bernard Le Mans, CLCC Eugène
on investigators' evaluations during local Committee (surgeons Marquis Rennes, CH Laval, CH St Malo, Polyclinique Océan St Nazaire, CH Landerneau, a median of overall survival of 29 months.
Polyclinique Maine Laval, CHU Nantes, CH St Brieuc, CH Lannion, CH Le Mans, CH
and oncologists). Morlaix, CH Lorient, CH Château Gontier, CH Quimper, CH Vannes, Polyclinique Parc This study is ongoing with expected results about 330 patients.
Cholet, CH Douarnenez, Polyclinique Sud Quimper
 Data analysis by OMIT Sory Traoré Biostastisticien, Brigitte Lemarquand Scientific researcher