Asco Gi Avastin 2009

([email protected]) patients Fonction All de survie

Patients Fonctions de survie

Number

How to answer the question : FOLFIRI BEVACIZUMAB, what results ? Use DATABASE from OMIT :

 Created in 2003 by Regional representatives of French Ministery of Health

 Collectiong data from both private and public hospitals  Developping discussion about clinical practice  Data patients treated with FOLFIRI BEVACIZUMAB

Evaluate efficacy and tolerance of this regimen in a cohort of non

Objective response rate % (nb) Stable disease % (nb) Progressive disease % (nb) Stop treatment because side effects

125 33% (41) 18% (23) 33% (41)

> 70 years

100

25

16% (16)

20% (5) 36% (9)

125 patients treated in 2006 Metastatic colorectal cancer in first line therapy Same protocol for all patients : BEVACIZUMAB : 5mg/kg biweekly

Progression free survival during treatment

Survie cumulée

Progression free survival 30

plus de 70 ans -censuré

e moins de 70 ans ,2 cu m de 70 ans moins ulé 0,0 -censuré

0

10

20

30

moins de 70 ans moins de 70 ans -censuré

0

Months Temps jusqu'à progression

10

20

30

Months

Temps jusqu'à progression avastan

Patientsde> 70 or < 70 years Fonctions survie

1,1

1,1

1,0

1,0

,9

,9

,8 ,7 ,6 ,5 ,4

Fonction de survie

,3

Censuré 10

20

30

Age > 70 years

,8

Age ,7

plus de 70 ans

Age plus de 70 ans

,6

40

< 70 years -censuré

,5

moins de 70 ans ,4

moins de 70 ans -censuré

,3 0

20

40

60

80

100

Durée de survie (en mois)Months

The median of overall survival is 29 months IC 95% [23,84 - 33,89].

Resecability liver metastasis

25% (32)

28% (28)

16% (4)

Resecability other metastasis

6% (7)

7% (7)

0

We observe a difference between patients > 70 or < 70 years but isn’t statistically significant (p > 0,05). Concerning the whole cohort, the 6 months-overall survival rate is 91%, the 18 months-overall survival rate is 62%.

 30% continued FOLFIRI or FOLFOX BEVACIZUMAB and 7% Folfiri alone  8 gastrointestinal toxicities (diarrhea, pain)

   

,5

Durée de survie (en mois)Months

16% (4)

doses

 Survival and 2nd line treatment

plus de 70 ans Su ,4 -censuré rvi

patients Fonction deAll survie

28% (7)

selected patients in usual clinical practice :

 % objective response  Resecability  Tolerance: side effects, hypertension, bleeding, adaptations

,6

plus de 70 ans

sion during BEVACIZUMAB.

0

16% (20)

,6 plus de 70 ans

patients > 70 (13,38 months) or < 70 years (18,6 months) for progres-

< 70 years

32% (32)

20

Age < 70 years

Age

[11,09 - 19,71]. We observe a significant difference (p < 0,05) between Patients

18% (18)

,7

Censuré ,3 10

,8

Age

Fonction de ,4 survie

,3

Age > 70 years

1,0

The median of progression free survival is 15,4 months IC 95%

Patients

34% (34)

,4

,8

Survie cumulée

All patients

,5

,9

Months Temps jusqu'à progression (en mois)

 36% of patients had had adjuvant chemotherapy

concerning ederly patients with age more than 70 years.

,6

0

20% of the patients were > 70 years

data are focused on FOLFIRI BEVACIZUMAB in first line UMCC especially

,7

1,0

Overall survival

to FOLFIRI (IFL equivalent European schedule). Very scarce prospective

,8

Survie cumulée

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

,9

Survie cumulée

Progression free survival

 61% M - 39% F  Mean age : 61 years [43-83] IC 95% [59-62]

1,0

Overall survival

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

1,2

1,1

1,1

In a phase III pivotal trial in patients with UMCC, BEVACIZUMAB

> 70 or < Fonctions 70 yearsde survie

   

1 ischemic stroke 1 thrombopenia 1 anaphylactic stroke

    

4 occlusions

Second line :

1 thrombosis

    

1 phlebitis 1 faint 1 dyspnea

1 epistaxis and rectal bleeding

21% : had no second line (remission, toxicity, stable disease, death) 30% : cetuximab irinotecan/Folfiri 14% : Folfox 2% : radiotherapy 3% : capecitabin based regimen

Association with so-called FOLFIRI regimen : irinotecan : 180 mg/m² biweekly + 5-FU : 400 mg/m² (bolus) and 2400 mg/m² (infusion 46h) + folic acid : 400 mg/m²

 45 private and public hospitals  Criteria for initial unresectability of metastatic lesions was based on investigators' evaluations during local Committee (surgeons and oncologists).

 Data analysis by OMIT

Acknowledgments For Private and public hospitals in Bretagne and Pays de la Loire: For clinicians, pharmacists, Directors CHU Brest, CH La Roche, Clinique Pasteur Brest, CLCC René Gauducheau Nantes, CLCC Paul Papin Angers, Clinique Océane Vannes, Centre Catherine Sienne Nantes, Clinique Armoricaine de Radiologie St Brieuc, Centre Jean Bernard Le Mans, CLCC Eugène Marquis Rennes, CH Laval, CH St Malo, Polyclinique Océan St Nazaire, CH Landerneau, Polyclinique Maine Laval, CHU Nantes, CH St Brieuc, CH Lannion, CH Le Mans, CH Morlaix, CH Lorient, CH Château Gontier, CH Quimper, CH Vannes, Polyclinique Parc Cholet, CH Douarnenez, Polyclinique Sud Quimper Sory Traoré Biostastisticien, Brigitte Lemarquand Scientific researcher

We present here the results from the french OMIT database concerning the use of Folfiri bevacizumab. This schedule is clearly feasible in non selected patients and especially in ederly patients. For all patients, there is a high rate of resection in UMCC in usual practice with a good response rate and a median of overall survival of 29 months. This study is ongoing with expected results about 330 patients.