Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

Age ≥ 18 years

Overall state as per WHO (World Health Organization) ≤ 2

Life expectancy \> 3 months

Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the primary tumor or a metastasis

Unresectable metastasis (metastases) and/or inoperable patient

Patient eligible for a 1st line treatment associating 5 FU-Irinotecan (FOLFIRI) and aflibercept

At least one measurable target lesion according to RECIST criteria v1.1 not previously irradiated

Absence of prior treatment of the metastatic disease. Prior adjuvant chemotherapy completed at least 12 months before the metastatic cancer diagnosis is authorized

Satisfactory laboratory panel: Hb\> 9 g/dl, polynuclear neutrophils \> 1500 /mm3, platelets \> 100,000/mm3, total bilirubin \< 1.5 x UNL(upper normal limit), creatinine clearance \> 50 mL/min (cockcroft-Gault formula - appendix 4), PAL (alkaline phosphatase) \< 5 x UNL, AST (aspartate aminotransferase) and ALT (alanine aminotransferases) \< 5 x UNL, GGT (gamma-glutamyltransferase) \< 5 x UNL,

Proteinuria on urine dipstick \< 2+. If \> 2+ test 24-hour proteinuria, which should be \< 1 g

Significant surgical intervention within the 28 days before the start of treatment

Presence of active gastroduodenal ulcer, non-healed wound or bone fracture

Antitumor treatments other than those included in the study (chemotherapy, targeted therapy, immunotherapy)

History of malignant hemopathy or cancer except for those treated more than 5 years ago and considered healed, in situ carcinomas of the uterine cervix and treated skin cancers (except for melanoma)

Pregnant or breast-feeding women, women of childbearing age not having taken a pregnancy test, absence of effective contraception in patients (men and/or women) of childbearing age

Any contraindication of the drugs used in the study

Impossible to meet the medical follow-up requirements of the study for geographic, social or psychological reasons

What this study is about