FOLFIRI + bevacizumab as first-line treatment in advanced colorectal cancer (ACC): Final results (prot. GOIM 2601)

e15007 Background: The addition of Bev to IFL obtained better OS and RR than chemotherapy alone. However IFL is not considered an optimal regimen and is certainly more toxic than FOLFIRI. To investigate the activity and efficacy of the addition of Bev to FOLFIRI, the GOIM started the following phase II study. Methods: seventy-two untreated pts with histologically/citologically confirmed diagnosis of colorectal cancer, with at least one measurable disease, age > 18 yrs, PS < 2 (ECOG), adequate bone marrow reserve and hepatic and renal function, with no history of cardiovascular disease, thromboembolic events or coagulative disorders and who signed informed written consent, were enrolled and received the following treatment: CPT-11 at 180 mg/m/mq on day 1, FA at 100 mg/mq as 2h infusion on days 1–2, FU at 400 mg/mq bolus on days 1–2 and FU at 600 mg/mq as 22h infusion on days 1–2 (FOLFIRI) plus Bev at 5 mg/Kg on day 1, every two weeks. A maximum of 12 cycles of chemotherapy was planned and a maintenance with Bev for 6 months was permitted. The evaluation of activity (Recist criteria) was performed every 4 cycles Results: all the enrolled pts were evaluable for activity and safety. Their main characteristics were M/F: 38/34; median PS: 0; median age 60 (range 33–73); primary site colon/rectum: 50/22 (69.4%/30.6%); main sites of disease liver: 50 (69.4%), lung: 18 (25%), lymph nodes: 19 (26.4%); synchronous/metacronous disease: 55/17 (77.7%/22.3%); multiple/single lesions: 40/32 (55.5%/44.5%).Seven (9.6%) CR, 25 (34.8%) PR, 33 (45.8%) SD and 7 PRO were observed for an ORR of 44.4% and a disease control of 90.3%. The response rate according to the main sites of disease were: liver 25/50 (50%), lung 6/18 (33.3%). The median number of administered cycle were 9 and the median TTP was 10.0 months. The main haematologic side-effects (% G3–4 NCI criteria) were: neutropenia 11%, thrombocytopenia 2.7% and anemia 4.7%, while diarrhea affected only 2.7% of pts; hypertension, thromboembolic and bleeding events were observed in 2.7%, 1.3% and 1.3% respectively. Conclusions: the addition of Bev to FOLFIRI is an active and effective first-line treatment in ACC with a good safety profile. Survival data will be presented during the meeting. No significant financial relationships to disclose.