title: Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1).
abstract: To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women with recurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstrated that trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) compared with placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% confidence interval 0.57-0.77; P < 0.001).
  
  
  
  HRQoL was assessed with the Functional Assessment of Cancer Therapy-Ovary [FACT-O; comprising FACT-G and the ovarian cancer-specific subscale (OCS)] and EuroQOL EQ-5D instruments before treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture model was used to evaluate the influence of patient dropout on FACT-O and OCS scores over time.
  
  
  
  Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment. At baseline, scores for all instruments were similar for both arms. At 25 weeks, mean ± SD changes from baseline were negligible, with mean ± SD changes typically <1 unit from baseline: -2.4 ± 16.6 in the trebananib arm and -1.6 ± 15.2 in the placebo arm for FACT-O, -0.71 ± 5.5 in the trebananib arm and -0.86 ± 4.9 in the placebo arm for OCS, and -0.02 ± 0.22 in the trebananib arm and 0.02 ± 0.19 in the placebo arm for EQ-5D. Distribution of scores was similar between treatment arms at baseline and over the course of the study. In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores. Edema had limited effect on either FACT-O or OCS scores in patients with grade ≥2 edema or those with grade 1 or no edema.
  
  
  
  Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved without compromising HRQoL.
  
  
  
  NCT01204749.
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan. Electronic address: fujiwara@saitama-med.ac.jp.
authors.forename: K
authors.initials: K
authors.lastname: Fujiwara
authors.affiliation: University of Arizona Cancer Center at Saint Joseph's Hospital and Medical Center, Phoenix, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Monk
authors.affiliation: Gustave Roussy, Villejuif, France.
authors.forename: C
authors.initials: C
authors.lastname: Lhommé
authors.affiliation: Department of Gynecologic Oncology, University of Texas MD Anderson Cancer Center, Houston, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Coleman
authors.affiliation: Hematology & Chemotherapy, Riga East Clinical University Hospital, Riga, Latvia.
authors.forename: A
authors.initials: A
authors.lastname: Brize
authors.affiliation: Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Oaknin
authors.affiliation: Department of Medicine, Centre Léon Bérard and University Claude Bernard, Lyon.
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.affiliation: Medical Oncology, Institut Régional du Cancer Montpellier, Montpellier, France.
authors.forename: M
authors.initials: M
authors.lastname: Fabbro
authors.affiliation: Department of Obstetrics and Gynecology, Centre Hospitalier de L'Université de Montreal Notre-Dame, Montreal, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Provencher
authors.affiliation: Department of Clinical Therapeutics, Alexandra Hospital, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Bamias
authors.affiliation: University Hospitals-KU Leuven, Leuven Cancer Institute, Leuven, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.affiliation: Medical Oncology, Ente Ospedaliero Ospedali Galliera, Genova, Italy.
authors.forename: A
authors.initials: A
authors.lastname: DeCensi
authors.affiliation: Amgen Inc., Thousand Oaks, USA.
authors.forename: K
authors.initials: K
authors.lastname: Zhang
authors.affiliation: Amgen Inc., Thousand Oaks, USA.
authors.forename: F D
authors.initials: FD
authors.lastname: Vogl
authors.affiliation: Amgen Inc., Thousand Oaks, USA.
authors.forename: B A
authors.initials: BA
authors.lastname: Bach
authors.affiliation: Surgery, Fondazione IRCCS Istituto Nazionale per la Cura e lo Studio dei Tumori, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Raspagliesi
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009389:Neovascularization, Pathologic / Q000188:drug therapy* / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage*; D015990:Placebo Effect; D011788:Quality of Life; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; D017239:Paclitaxel; C551398:trebananib
keywords: edema; health-related quality of life; recurrent ovarian cancer; trebananib