ICON7 Final overall survival results in the GCIG phase III randomized trial of bevacizumab in women with newly diagnosed ovarian cancer

SUMMARY: ICON7 is a randomized phase III trial in which the safety and efficacy of combining AVASTIN® (Bevacizumab) with standard chemotherapy was evaluated in patients with Newly Diagnosed Ovarian Cancer. One thousand five hundred and twenty eight (n=1528) patients with high-risk (grade 3 or clear cell histology) stage I-IIa or stage IIb-IV epithelial ovarian, primary peritoneal or fallopian tube cancer, were randomized to receive either 6 cycles of combination chemotherapy with PARAPLATIN® (Carboplatin) AUC of 5 or 6 and TAXOL® (Paclitaxel) 175mg/m2 given every 3 weeks or the same chemotherapy regimen given concurrently with AVASTIN® (Bevacizumab) 7.5mg/kg, every 3 weeks for 5 or 6 cycles followed maintenance AVASTIN® for 12 additional cycles or until disease progression, whichever was the earlier. The median age was 57 years. Approximately 33% of the patients randomized were considered poor prognosis group, at high risk for progression. At the first interim analysis, the addition of AVASTIN® to standard chemotherapy, followed by maintenance AVASTIN® demonstrated improved Progression Free Survival (PFS) compared to standard chemotherapy alone (19 vs17.3 months, P=0.0041). In the planned Final analysis, at a median follow up of 49 months, the PFS superiority in the AVASTIN® group was maintained, similar to the first analysis but there was no improvement in the median Overall Survival (OS) between the two treatment groups. However, in the predefined high-risk, poor prognostic subgroup of patients, AVASTIN® improved OS by 4.8 months, without any major adverse events. The authors concluded that the addition of AVASTIN® to standard chemotherapy can translate into clinically meaningful survival benefit, for patients with high risk disease. Oza AM, Perren TJ, Swart AM, et al. European Cancer Congress. Abstract 6. Presented on September 29, 2013.