Τίτλος:
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
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Monk, B.J.
Poveda, A.
Vergote, I.
Raspagliesi, F.
Fujiwara, K.
Bae, D.-S.
Oaknin, A.
Ray-Coquard, I.
Provencher, D.M.
Karlan, B.Y.
Lhommé, C.
Richardson, G.
Rincón, D.G.
Coleman, R.L.
Marth, C.
Brize, A.
Fabbro, M.
Redondo, A.
Bamias, A.
Ma, H.
Vogl, F.D.
Bach, B.A.
Oza, A.M.
Περιοδικό:
Gynecologic Oncology
Εκδότης:
Academic Press Inc.
Λέξεις-κλειδιά:
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
DOI:
10.1016/j.ygyno.2016.07.112
