978P - ROSIA: a single-arm study in more than 1000 patients (pts) receiving front-line bevacizumab (BEV) + chemotherapy (CT) for ovarian cancer (OC)

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Ovarian Cancer
Presenter Cesar Mendiola
Authors C. Mendiola1, I. Davidenko2, N. Colombo3, J. Korach4, F. Selle5, P. Gocze6, E. Chmielowska7, P. Pautier8, D. Bollag9, A.M. Oza10
  • 1Medical Oncology Service, University Hosptial 12 De Octubre Medical oncology, 28041 - Madrid/ES
  • 2Krasnodar Regional Clinical Oncology Center, 350040 - Krasnodar/RU
  • 3European Institute of Oncology, 20141 - Milan/IT
  • 4Gynecology Oncology, The Chaim Sheba Medical Center, 52621 - Tel Hashomer/IL
  • 5Medical Oncology, Hôpital Tenon, 75020 - Paris/FR
  • 6Department Of Obstetrics And Gynaecology, University of Pecs, Pecs/HU
  • 7Oddzial Onkologii, SPZOZ Centrum Onkologii im. Prof.Lukaszczyka, 85-796 - Bydgoszcz, NAP/PL
  • 8Medecine Oncologique, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 9Pbmo, F. Hoffmann- La Roche AG, CH-4070 - Basel/CH
  • 10Dept. Of Medicine, Princess Margaret Hospital, CA-M5G 2M9 - Toronto/CA

Abstract

Background

BEV significantly improved the efficacy of front-line CT for OC in the ICON7 and GOG-0218 phase III trials. The global single-arm ROSiA study was designed to assess the safety of BEV-containing therapy, given until progression or for up to 36 cycles, in the context of routine oncology practice.

Methods

Eligible pts have FIGO stage IIb–IV or grade 3 stage I–IIa epithelial ovarian, fallopian tube or primary peritoneal carcinoma, have received no prior post-surgical therapy for OC, are aged ≥18 years and have ECOG PS 0–2. Prior neoadjuvant CT is permitted. Pts with uncontrolled hypertension, clinical signs/symptoms of GI obstruction, or a history of abdominal fistula, GI perforation or intra-abdominal abscess within the preceding 6 months are ineligible. After definitive surgery, pts receive BEV 15 mg/kg q3w (or 7.5 mg/kg at the investigator's discretion) in combination with 4–8 cycles of CT (paclitaxel [175 mg/m2 d1 q3w or 80 mg/m2 qw) + q3w carboplatin [AUC 5 or 6]). BEV is continued at the same dose as a single agent until disease progression (PD), unacceptable toxicity or for up to 36 cycles. The primary objective is to assess safety (CTCAE v4.03). Secondary endpoints include progression-free survival, overall response rate by RECIST and/or CA-125 response criteria, duration of response and overall survival. The study includes exploration of potential correlations of plasma, tumour and genetic biomarkers with BEV efficacy and toxicity.

Results

Between Dec 2010 and Apr 2012, ∼1000 pts were enrolled from 35 countries, predominantly Spain (n = 180), Italy (n = 110) and France (n = 101). Baseline characteristics were available from 677 pts as of 30 Jan 2012. Most pts had stage III/IV OC (stage I/II/III/IV: 7%/11%/60%/18%). The majority (93%) received paclitaxel q3w and 94% received BEV at a dose of 15 mg/kg; 14% had received prior neoadjuvant CT. Baseline characteristics from the entire population of ∼1000 pts will be reported, together with details of CT and BEV schedules selected.

Conclusions

ROSiA should provide valuable new information on the safety of BEV for up to 36 cycles and in pts who have received neoadjuvant CT, as well as enabling extensive translational research.

Disclosure

N. Colombo: NC has received honoraria for advisory boards and speaker engagements from Roche. F. Selle: FS acts as a Consultant for Roche and PharmaMar. P. Pautier: PP has served on Advisory Boards for Roche and Ipsen. D. Bollag: DB is an employee and holds stocks in F Hoffmann-La Roche Ltd. A.M. Oza: AO has received research funding from Roche. All other authors have declared no conflicts of interest.