TY - JOUR
TI - 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
AU - Monk, B.J.
AU - Poveda, A.
AU - Vergote, I.
AU - Raspagliesi, F.
AU - Fujiwara, K.
AU - Bae, D.-S.
AU - Oaknin, A.
AU - Ray-Coquard, I.
AU - Provencher, D.M.
AU - Karlan, B.Y.
AU - Lhommé, C.
AU - Richardson, G.
AU - Rincón, D.G.
AU - Coleman, R.L.
AU - Marth, C.
AU - Brize, A.
AU - Fabbro, M.
AU - Redondo, A.
AU - Bamias, A.
AU - Ma, H.
AU - Vogl, F.D.
AU - Bach, B.A.
AU - Oza, A.M.
JO - Gynecologic Oncology
PY - 2016
VL - 143
TODO - 1
SP - 27-34
PB - Academic Press Inc.
SN - 0090-8258, 1095-6859
TODO - 10.1016/j.ygyno.2016.07.112
TODO - 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
TODO - 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.
ER -