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

被引：74

作者：

Monk, Bradley J. ^{[1
]}

Poveda, Andres ^{[2
]}

Vergote, Ignace ^{[3
]}

Raspagliesi, Francesco ^{[4
]}

Fujiwara, Keiichi ^{[5
]}

Bae, Duk-Soo ^{[6
]}

Oaknin, Ana ^{[7
]}

Ray-Coquard, Isabelle ^{[8
]}

Provencher, Diane M. ^{[9
]}

Karlan, Beth Y. ^{[10
]}

Lhomme, Catherine ^{[11
]}

Richardson, Gary ^{[12
]}

Rincon, Dolores Gallardo ^{[13
]}

Coleman, Robert L. ^{[14
]}

Marth, Christian ^{[15
]}

Brize, Arija ^{[16
]}

Fabbro, Michel ^{[17
]}

Redondo, Andres ^{[18
]}

Bamias, Aristotelis ^{[19
]}

Ma, Haijun ^{[20
]}

Vogl, Florian D. ^{[21
]}

Bach, Bruce A. ^{[21
]}

Oza, Amit M. ^{[22
]}

机构：

[1] Univ Arizona, Canc Ctr Dign Hlth, St Josephs Hosp & Med Ctr, Dept Obstet & Gynecol, Phoenix, AZ USA

[2] Fdn Inst Valenciano Oncol, Area Clin Oncol Ginecol, Valencia, Spain

[3] Katholieke Univ Leuven, European Union, Dept Obstet & Gynecol, Univ Hosp Leuven,Leuven Canc Inst, Leuven, Belgium

[4] Fdn IRCCS, Gynecol Oncol Unit, Ist Nazl Cura & Studio Tumori, Milan, Italy

[5] Saitama Med Univ, Dept Gynecol Oncol, Int Med Ctr, Hidaka, Saitama, Japan

[6] Samsung Med Ctr, Dept Obstet & Gynecol, Seoul, South Korea

[7] Vail dHebron Univ Hosp, Vall dHebron Inst Oncol, Barcelona, Spain

[8] Univ Lyon 1, Ctr Leon Berard, Lyon, France

[9] Ctr Hosp Univ Montreal, Div Gynecol Oncol, Montreal, PQ, Canada

[10] Cedars Sinai Med Ctr, Womens Canc Program, Samuel Oschin Comprehens Canc Ctr, Los Angeles, CA 90048 USA

[11] Inst Gustave Roussy, Dept Med, Villejuif, France

[12] Cabrini Hosp, Acad Haematol & Oncol, Malvern, Vic, Australia

[13] Inst Nacl Cancerol, Subdirecc Med Interna, Mexico City, DF, Mexico

[14] Univ Texas MD Anderson Canc Ctr, Dept Gynecol Oncol & Reprod Med, Houston, TX 77030 USA

[15] Med Univ Innsbruck, Univ Klin Gynakol & Geburtshilfe, Innsbruck, Austria

[16] Riga Eastern Clin Univ Hosp, Latvian Oncol Ctr, Riga, Latvia

[17] Reg Canc Inst Montpellier, Montpellier, France

[18] Hosp Univ La Paz Idi Paz, Madrid, Spain

[19] Natl & Kapodistrian Univ Athens, Alexandra Hosp, Dept Clin Therapeut, Athens, Greece

[20] Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA

[21] Amgen Inc, Global Dev Oncol, Thousand Oaks, CA 91320 USA

[22] Univ Toronto, Princess Margaret Hosp, Dept Med, Toronto, ON M5S 1A1, Canada

来源：

GYNECOLOGIC ONCOLOGY | 2016年 / 143卷 / 01期

关键词：

Trebananib; TRINOVA-1; Recurrent epithelial ovarian cancer; Overall survival; Ascites; Time to second disease progression; ADVANCED EPITHELIAL OVARIAN; MALIGNANT ASCITES; FALLOPIAN-TUBE; DOUBLE-BLIND; CLINICAL-TRIAL; END-POINTS; BEVACIZUMAB; ANGIOGENESIS; CHEMOTHERAPY; THERAPY;

D O I：

10.1016/j.ygyno.2016.07.112

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpbse. 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 interit-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/m(2) (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. (C) 2016 Elsevier Inc. All rights reserved.

引用

页码：27 / 34

页数：8

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