Overall survival results of ICON6: A trial of chemotherapy and cediranib in relapsed ovarian cancer.

• DOI: 10.1200/jco.2017.35.15_suppl.5506
• Publication Date: 2018-09-06T15:46:45Z
• Authors: Jonathan A. Leder...; Andrew C. Embleton; Timothy Perren; Gordon C. Jayson; Gordon J. S. Rustin; Stanley B. Kaye; Hal W. Hirte; Amit M. Oza; Michelle Margaret...; Michael Friedlander; Antonio Gonzalez ...; Elizabeth Clark; Babasola O Popoola; Laura Farrelly; Ann Marie Swart; Adrian Cook; Richard S. Kaplan; Mahesh K B Parmar
• Keywords: Clinical endpoint; Log-rank test

5506 Background: ICON6 is a three-arm double-blind, placebo-controlled phase 3 trial of cediranib in platinum-sensitive relapsed ovarian cancer (NCT00532194). The primary analysis (Ledermann et al Lancet 2016) showed significant (p < 0.0001), 2.3 month extension progression-free survival (PFS) using with chemotherapy and as maintenance compared to placebo. We present the final overall (OS) results. Methods: was originally designed recruit 2000 patients OS endpoint. AstraZeneca discontinued development Sep 2011, leading an unplanned redesign prior analysis. sample size reduced outcome became PFS, comparing two arms, placebo (A) given (C). In arm B followed by maintenance. Analysis PFS performed on 456 receiving 20mg dose cediranib. At analysis, 52% had died; this mature after 85% died. Results: at median 25.6 months follow up; 102/118 (86%) died A 140/164 (85%) C. 19.9 (95% CI: 17.4, 26.5) C 27.3 (24.8, 33.0). Using logrank test Hazard Ratio estimate 0.85 (0.66, 1.10) favour = 0.21). Evidence non-proportionality curves observed 0.0029), so we measured Restricted Mean Survival Time alternative median. Over 6 years, there 4.8 (-0.1, 9.8) increase time death A, from 29.4 34.2 months. mean for (32.0 months) consistent benefit increased use Conclusions: Cediranib has demonstrated effect increasing PFS. shows improvement 7.4 months, incremental use. previously published coupled highlights potential value recurrent cancer. Further exploration setting underway. Clinical information: NCT00532194.