title: Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recurrent disease.
abstract: This manuscript reports the consensus statements regarding recurrent ovarian cancer (ROC), reached at the fifth Ovarian Cancer Consensus Conference (OCCC), which was held in Tokyo, Japan, in November 2015. Three important questions were identified: (i) What are the subgroups for clinical trials in ROC? The historical definition of using platinum-free interval (PFI) to categorise patients as having platinum-sensitive/resistant disease was replaced by therapy-free interval (TFI). TFI can be broken down into TFIp (PFI), TFInp (non-PFI) 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. (ii) 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. (iii) What are the endpoints for clinical trials in ROC? Overall survival (OS) is the preferred endpoint for patient cohorts with an expected median OS < or = 12 months. Progression-free survival (PFS) is an alternative, and it is the preferred endpoint when the expected median OS is > 12 months. However, PFS alone should not be the only endpoint and must be supported by additional endpoints including pre-defined patient reported outcomes (PROs), time to second subsequent therapy (TSST), or time until definitive deterioration of quality of life (TUDD).
authors.affiliation: ANZGOG, Sydney, Australia-New Zealand.
authors.forename: M K
authors.initials: MK
authors.lastname: Wilson
authors.affiliation: GINECO, Paris, France.
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
authors.affiliation: JGOG, Tokyo, Japan.
authors.forename: D
authors.initials: D
authors.lastname: Aoki
authors.affiliation: NSGO, Copenhagen, Scandinavia.
authors.forename: M R
authors.initials: MR
authors.lastname: Mirza
authors.affiliation: MITO, Milano, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Lorusso
authors.affiliation: PMHC, Toronto, Canada.
authors.forename: A M
authors.initials: AM
authors.lastname: Oza
authors.affiliation: AGO, Essen, Germany.
authors.forename: A
authors.initials: A
authors.lastname: du Bois
authors.affiliation: BGOG, Leuven, Kingdom of Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.affiliation: AGO, Essen, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Reuss
authors.affiliation: GCIG, Kingston, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Bacon
authors.affiliation: ANZGOG, Sydney, Australia-New Zealand.
authors.forename: M
authors.initials: M
authors.lastname: Friedlander
authors.affiliation: GICOM, Mexico.
authors.forename: D
authors.initials: D
authors.lastname: Gallardo-Rincon
authors.affiliation: GINECO, Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Joly
authors.affiliation: KGOG, Suwon, Korea.
authors.forename: S-J
authors.initials: SJ
authors.lastname: Chang
authors.affiliation: ManGO, Turin, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Ferrero
authors.affiliation: MRC/NCRI, Gateshead, UK.
authors.forename: R J
authors.initials: RJ
authors.lastname: Edmondson
authors.affiliation: NOGGO, Dresden, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Wimberger
authors.affiliation: NSGO, Copenhagen, Scandinavia.
authors.forename: J
authors.initials: J
authors.lastname: Maenpaa
authors.affiliation: RTOG, Salt Lake City, USA.
authors.forename: D
authors.initials: D
authors.lastname: Gaffney
authors.affiliation: SGOG, Shanghai, China.
authors.forename: R
authors.initials: R
authors.lastname: Zang
authors.affiliation: JGOG, Tokyo, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Okamoto
authors.affiliation: CCTG, Vancouver, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Stuart
authors.affiliation: JGOG, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ochiai
mesh_terms: D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000473:pathology* / Q000628:therapy*; D012107:Research Design
keywords: clinical trials; ovarian cancer; recurrent disease