5th Ovarian Cancer Consensus Conference of the Gyn Cancer InterGroup: Recurrent Disease

abstract
 

1. ¹ ANZGOG, Australia-New Zealand; ²GINECO, France; ³JGOG, Japan; ⁴ NSGO, Scandinavia; ⁵MITO, Italy, ⁶PMHC, Canada; ⁷AGO, Germany; ⁸BGOG, Kingdom of Belgium; ⁹GCIG; ¹⁰GICOM, Mexico; ¹¹KGOG, Korea; ¹²ManGO, Italy; ¹³MRC/NCRI, UK; ¹⁴NOGGO, Germany; ¹⁵RTOG, USA; ¹⁶SGOG, China; ¹⁷CCTG, Canada

November 23, 2016.

This manuscript reports the consensus statements regarding recurrent ovarian cancer (ROC), reached at the 5th Ovarian Cancer Consensus Conference (OCCC), which was held in Tokyo, Japan, in November 2015. Three important questions were identified: (1) What are the subgroups for clinical trials in ROC? The historical definition of using platinum-free interval (PFI) to categorize patients as having platinum-sensitive/resistant disease was replaced by therapy-free interval (TFI). TFI can be broken down into TFIp (platinum-free interval), TFInp (non-platinum-free interval) and TFIb (biological agent-free interval). Additional criteria to consider include histology, BRCA mutation status, number/type of previous therapies, outcome of prior surgery and patient reported symptoms. (2) What are the control arms for clinical trials in ROC? When platinum is considered the best option, the control arm should be a platinum-based therapy with or without an anti-angiogenic agent or a poly (ADP-ribose) polymerase (PARP) inhibitor. If platinum is not considered the best option, the control arm could include a non-platinum drug, either as single agent or in combination. (3) What are the endpoints for clinical trials in ROC? Overall survival (OS) is the preferred endpoint for patient cohorts with an expected median OS less than or equal to 12 months. Progression-free survival (PFS) is an alternative, and it is the preferred endpoint when the expected median OS is more than 12 months. However, PFS alone should not be the only endpoint and must be supported by additional endpoints including predefined patient reported outcomes (PROs), time to second subsequent therapy (TSST), or time until definitive deterioration of quality of life (TUDD).