title: Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.
abstract: BACKGROUND
  OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear.
  
  
  METHODS
  within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup.
  
  
  RESULTS
  Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months).
  
  
  CONCLUSIONS
  This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).
authors.affiliation: Area of Gynecologic Oncology, Valencian Institute of Oncology, Valencia, Spain. Electronic address: apoveda@fivo.org.
authors.forename: A
authors.initials: A
authors.lastname: Poveda
authors.affiliation: Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.
authors.forename: S
authors.initials: S
authors.lastname: Tjulandin
authors.affiliation: Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.
authors.forename: B
authors.initials: B
authors.lastname: Kong
authors.affiliation: Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Roy
authors.affiliation: Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.
authors.forename: S
authors.initials: S
authors.lastname: Chan
authors.affiliation: Chemotherapy Department, Oncology Center, Wroclaw, Poland.
authors.forename: E
authors.initials: E
authors.lastname: Filipczyk-Cisarz
authors.affiliation: Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.
authors.forename: H
authors.initials: H
authors.lastname: Hagberg
authors.affiliation: Department of Cancer Medicine, The Royal Mardsen Hospital, Sutton, Surrey, UK.
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
authors.affiliation: Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Colombo
authors.affiliation: Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Lebedinsky
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.
authors.forename: T
authors.initials: T
authors.lastname: Parekh
authors.affiliation: Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Gómez
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.
authors.forename: Y C
authors.initials: YC
authors.lastname: Park
authors.affiliation: Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Alfaro
authors.affiliation: Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Monk
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004149:Dioxoles / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000009:adverse effects; D000077606:Trabectedin; D016896:Treatment Outcome
chemical_list: D004149:Dioxoles; D009944:Organoplatinum Compounds; D044005:Tetrahydroisoquinolines; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000077606:Trabectedin