880PD - Pazopanib versus placebo in women without progression after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary per...

Date 28 September 2014
Event ESMO 2014
Session Gynaecological cancers
Topics Anti-Cancer Agents & Biologic Therapy
Ovarian Cancer
Presenter Hiroyuki Nomura
Citation Annals of Oncology (2014) 25 (suppl_4): iv305-iv326. 10.1093/annonc/mdu338
Authors H. Nomura1, L. Hanker2, M. Fabbro3, J. Rau4, Y. Kim5, J.A. Arranz Arija6, M. Friedlander7, G. Ferrandina8, P. Vuylsteke9, N. Colombo10, S. Malander11, B.J. Monk12, E. Petru13, P. Calvert14, T. Herzog15, C. Barrett16, M. Jobanputra17, Q. Wang18, G. Elser19, A. du Bois20
  • 1Department Of Obstetrics And Gynecology, Keio University, 160-8582 - Shinjuku ku/JP
  • 2Department Of Gynecology & Obstetrics, University of Schleswig-Holstein, Luebeck/DE
  • 3Oncology, Institut regional du Cancer, Montpellier/FR
  • 4Coordinating Center For Clinical Trials, Philipps-University of Marburg, Marburg/DE
  • 5Dept. Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 6Servicio De Oncologia Medica, Hospital General Univ. Gregorio Marañon, 28007 - Madrid/ES
  • 7Oncology, ANZGOG and Prince of Wales Clinical School, University of New South Wales, Sydney/AU
  • 8Gynecologic Oncology, Catholic University, Rome/IT
  • 9Medical Oncology, Hopital Sainte-Elizabeth Namur, Namur/BE
  • 10Oncology, European Institute of Oncology, Milan/IT
  • 11Department Of Oncology, University Hospital, Lund/SE
  • 12Division Of Gynecologic Oncology, Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center, Phoenix/US
  • 13Klinische Abteilung Für Gynäkologie, Medical University of Graz, Graz/AT
  • 14Oncology, All-Ireland Cooperative Oncology Research Group, Dublin/IE
  • 15Division Of Gynecologic Oncology, Columbia University Medical Center, 10032 - New York/US
  • 16Clinical Research, GlaxoSmithKline Pharmaceuticals, Uxbridge/GB
  • 17Oncology Global Business, GlaxoSmithKline, Uxbridge/GB
  • 18Oncology Biometrics And Epidemiology, GlaxoSmithKline Pharmaceuticals, Collegeville/US
  • 19Ago Study Group, AGO Study Group, Wiesbaden/DE
  • 20Department Of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte, Essen/DE

Abstract

Aim

We previously reported results from AGO-OVAR16 (NCT00866697), a randomized, double-blind, placebo-controlled phase 3 trial that evaluated the efficacy, safety, and tolerability of pazopanib maintenance therapy in patients without disease progression after first-line chemotherapy for AEOC (du Bois et al, ASCO 2013; abstract LBA5503). Patients in the pazopanib arm had longer progression-free survival (PFS) versus those in the placebo arm (HR = 0.766; 95% CI: 0.643, 0.911; P = .0021; medians 17.9 vs 12.3 months, respectively). The first interim analysis for overall survival (OS) after 190 deaths (20% of the study population) revealed no difference between arms (HR = 0.994; 95% CI: 0.747, 1.321). In this report we present updated results from the planned second interim OS analysis after 335 events (36% of the study population; 61% of events required for the final OS analysis, which will be performed after 551 events).

Methods

Eligible patients had histologically confirmed AEOC, FIGO stage II-IV, and no evidence of disease progression after surgery and ≥ 5 cycles of platinum-taxane chemotherapy. Patients were randomized 1:1 to receive pazopanib 800 mg once daily or placebo for up to 24 months. The primary endpoint was PFS by RECIST. Secondary endpoints included OS, safety, and quality of life.

Results

A total of 940 patients were randomized. At this second interim analysis of OS, 172 patients (36%) in the pazopanib arm and 163 patients (35%) in the placebo arm had died (HR = 1.076; 95% CI: 0.868, 1.333; P = .4985). The majority of deaths in each arm were attributed to the cancer under study. Additional subgroup analyses are ongoing and will be presented.

Conclusions

Results from this updated OS analysis are consistent with the first interim analysis. Although maintenance therapy with pazopanib in AEOC significantly prolonged PFS in the overall study population, no difference in OS was observed in the planned second interim OS analysis.

Disclosure

J.A. Arranz Arija: I have received honorarium for participating in advisory boards organized by GSK. I have received honorarium for participating as speaker in meetings organized by GSK. I do not have other economic relationships nor interest with GSK; N. Colombo: I have to declare participation in advisory boards; B.J. Monk: I have received honoraria for Advisory Boards. GSK supports research done at my institution and the payments do not go to me; T. Herzog: Consultant via advisory boards: Az, Roche, merk, morphotek No other as no speaker bureaus stock etc; C. Barrett and M. Jobanputra: I am employed by GlaxoSmithKline and hold GSK stock; Q. Wang: I'm a GSK employee and own GSK stocks. I do not have anything else to disclose; A. Du Bois: Consultant/advisor for Roche, Pharmamar, Amgen, and MSD Honoraria received from Roche, Johnson & Johnson, Pharmamar and MSD. All other authors have declared no conflicts of interest.