@article{3100816,
    title = "Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2",
    author = "Monk, B.J. and Poveda, A. and Vergote, I. and Raspagliesi, F. and Fujiwara, K. and Bae, D.-S. and Oaknin, A. and Ray-Coquard, I. and Provencher, D.M. and Karlan, B.Y. and Lhommé, C. and Richardson, G. and Rincón, D.G. and Coleman, R.L. and Marth, C. and Brize, A. and Fabbro, M. and Redondo, A. and Bamias, A. and Ma, H. and Vogl, F.D. and Bach, B.A. and Oza, A.M.",
    journal = "Gynecologic Oncology",
    year = "2016",
    volume = "143",
    number = "1",
    pages = "27-34",
    publisher = "Academic Press Inc.",
    issn = "0090-8258, 1095-6859",
    doi = "10.1016/j.ygyno.2016.07.112",
    keywords = "paclitaxel;  placebo;  trebananib;  antineoplastic agent;  hybrid protein;  paclitaxel;  trebananib, adult;  aged;  anemia;  artery thrombosis;  Article;  ascites;  blurred vision;  cancer combination chemotherapy;  cancer survival;  controlled study;  diabetic ketoacidosis;  digestive system perforation;  drug withdrawal;  edema;  female;  generalized edema;  human;  hypertension;  intention to treat analysis;  long term survival;  lung embolism;  major clinical study;  median survival time;  multicenter study (topic);  neutropenia;  ovary carcinoma;  overall survival;  phase 3 clinical trial (topic);  pleura effusion;  priority journal;  progression free survival;  randomized controlled trial (topic);  recurrent disease;  rhinopharyngitis;  sepsis;  side effect;  treatment outcome;  venous thromboembolism;  weight gain;  wound healing impairment;  ascites;  clinical trial;  complication;  disease free survival;  double blind procedure;  middle aged;  mortality;  Ovarian Neoplasms;  phase 3 clinical trial;  randomized controlled trial;  tumor recurrence;  very elderly, Adult;  Aged;  Aged, 80 and over;  Antineoplastic Combined Chemotherapy Protocols;  Ascites;  Disease-Free Survival;  Double-Blind Method;  Female;  Humans;  Middle Aged;  Neoplasm Recurrence, Local;  Ovarian Neoplasms;  Paclitaxel;  Recombinant Fusion Proteins",
    abstract = "Purpose Trebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2). Patients and methods Women with recurrent disease (platinum-free interval < 12 months) were randomized to receive intravenous paclitaxel 80 mg/m2 (3 weeks on/1 week off) plus intravenous trebananib 15 mg/kg or placebo, weekly. OS in the intent-to-treat population was a key secondary endpoint. Exploratory analysis of PFS-2 was conducted according to guidance by the European Medicines Agency. Results Median OS was not significantly improved with trebananib compared with placebo (19.3 versus 18.3 months; HR, 0.95; 95% CI, 0.81–1.11; P = 0.52) in the intent-to-treat population (n = 919). In subgroup analysis, trebananib improved median OS compared with placebo (14.5 versus 12.3 months; HR, 0.72; 95% CI, 0.55–0.93; P = 0.011) in patients with ascites at baseline (n = 295). In the intent-to-treat population, trebananib significantly improved median PFS-2 compared with placebo (12.5 versus 10.9 months; HR, 0.85; 95% CI, 0.74–0.98; P = 0.024). The incidence and type of adverse events in this updated analysis was consistent with that described in the primary analysis; no new safety signals were detected. Conclusions OS was not significantly longer in the intent-to-treat population, although there was an improvement in OS in patients with ascites receiving trebananib. PFS-2 confirmed that the PFS benefit associated with trebananib was maintained through the second disease progression independent of the choice of subsequent therapy. © 2016 Elsevier Inc."
}