Results of ICON7: a phase III randomised Gynaecologic Cancer InterGroup trial of concurrent bevacizumab and chemotherapy followed by maintenance bevacizumab, versus chemotherapy alone in women with newly diagnosed epithelial ovarian (EOC), primary peritoneal (PPC) or fallopian tube cancer (FTC). Medical Research Council Cancer Trials Unit, presented on behalf of the GCIG ICON7 collaborators
Session type: Clinical Trials Showcase
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor. Evidence of activity and acceptable toxicity provided the basis for its investigation in a phase III trial.
Women with newly diagnosed advanced (stage IIb-IV) EOC, PPC or FTC or high-risk early (FIGO stage I or IIa (grade 3 or clear cell) were randomised (1:1) to 6 cycles of 3 weekly chemotherapy (carboplatin AUC 6 and paclitaxel 175mg/m2) alone, or chemotherapy plus bevacizumab (7.5mg/kg) for 6 cycles followed by maintenance bevacizumab alone continued to a maximum of 18 cycles, or until protocol defined disease progression. The primary outcome measure was RECIST defined progression free survival (PFS). Secondary outcome measures include response, overall survival, safety, and quality of life (QoL) assessed by EORTC QLQ 30 OV28. To show a 28% improvement in median PFS from 18 to 23 months (90% power, 2 sided significance level of 5%) 684 progressions or deaths were required.
Dec 2006 to Feb 2009, 1528 women (90% with epithelial ovarian cancer) were randomised from 294 centres in 7 GCIG groups. Baseline characteristics were well balanced with median age (57 years), ECOG performance status 0/1 (46%/48%), high risk early disease (9%), histology (69% serous, 8% endometrioid, 8% clear cell). 67%, 20% and 13% of patients had stage I-III optimally debulked, I-III suboptimally debulked and stage IV disease respectively. Data were mature for the primary analysis with a final clean data set in Jun 2010. Results of the effect of bevacizumab on PFS along with treatment details, safety and QoL analyses will be available for submission on 25 August 2010.
ICON7 is an MRC/NCRI led trial which will provide important data on the role of bevacizumab in the treatment of ovarian cancer.