Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: first-line interventions

The consensus statements regarding first-line therapies in women with ovarian cancer, reached at the Fifth Ovarian CancerConsensus Conference held in Tokyo, Japan, in November 2015 are reported. Three topics were reviewed and the following statements are recommended: (i) Surgery: the subgroups that should be considered in first-line ovarian cancerclinical trials should be (a) patients undergoing primary debulkingsurgery and (b) patients receiving neo-adjuvant chemotherapy. The amount of residual disease following surgery should further stratify patients into those with absent gross residual disease and others. (ii) Control armsfor chemotherapy: for advanced stage ovarian cancerthe standard is intravenous 3-weekly carboplatinand paclitaxel. Acceptable alternatives, which should be stratified variables in trials when more than one regimen is offered, include weekly paclitaxelplus 3-weekly carboplatin, the addition of bevacizumab to 3-weekly carboplatinand paclitaxel, and intraperitoneal therapy. (iii) Trial Endpoints: overall survival is the preferred primary endpoint for first-line clinical trials with or without a maintenance component. Progression-free survival (PFS) is an alternative primary endpoint, but if PFS is chosen overall survival must be measured as a secondary endpoint and PFS must be supported by additional endpoints, including predefined patient reported outcomesand time to first or second subsequent therapy. For neoadjuvant therapy, additional ‘ windowof opportunity’ endpoints should be included.