The consensus statements regarding first-line therapies in women with ovarian cancer, reached at the Fifth Ovarian Cancer Consensus 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 cancer clinical trials should be (a) patients undergoing primary debulking surgery 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 arms for chemotherapy: for advanced stage ovarian cancer the standard is intravenous 3-weekly carboplatin and paclitaxel. Acceptable alternatives, which should be stratified variables in trials when more than one regimen is offered, include weekly paclitaxel plus 3-weekly carboplatin, the addition of bevacizumab to 3-weekly carboplatin and 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 outcomes and time to first or second subsequent therapy. For neoadjuvant therapy, additional 'window of opportunity' endpoints should be included.
ContributorsKaram, A. Ledermann, J. A. Kim, J. W. Sehouli, J. Lu, K. Gourley, C. Katsumata, N. Burger, R. A. Nam, B. H. Bacon, M. Ng, C. Pfisterer, J. Bekkers, R. L. M. Casado Herraez, A. Redondo, A. Fujiwara, H. Gleeson, N. Rosengarten, O. Scambia, G. Zhu, J. Okamoto, A. Stuart, G. Ochiai, K. participants of the 5th Ovarian Cancer Consensus, Conference
Disease Category: Cancer
Disease Name: Ovarian cancer
Age Range: Unknown
Sex: Female
Nature of Intervention: Drug
- Members of a clinical trial network.
- Pharmaceutical industry representatives
- Researchers
- COS for clinical trials or clinical research
- Consensus conference