520P - Overall survival according to patient subgroups: Results from a pooled analysis of 5 observational or phase IV studies of bevacizumab in metastatic...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Axel Grothey
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors A. Grothey1, D. Arnold2, E. Van Cutsem3, T. Bekaii-Saab4, M. Kozloff5, J. Bennouna6, C. Revil7, M. Donica7, N. Sommer8, B. Leutgeb9, M. Ekstrand-Olsen10, F. Hermann11, H. Hurwitz12
  • 1Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 2Medical Oncology, Klinik fuer Tumorbiologie, Freiburg/DE
  • 3Digestive Oncology, University Hospital Leuven and KU Leuven, 3000 - Leuven/BE
  • 4Medical Center, The Ohio State University, 43210 - Columbus/US
  • 5Hematology/oncology, Ingalls Hospital and University of Chicago, Harvey/US
  • 6Department Of Medical Oncology, Institut de Cancérologie de l'Ouest, 44805 - Saint-Herblain/FR
  • 7Global Medical Affairs Operations (biometrics), F. Hoffmann-La Roche, Ltd., Basel/CH
  • 8Medical Affairs, Genentech, Inc., South San Francisco/US
  • 9Gi-gu-neuro-oncology, F. Hoffmann-La Roche, Ltd., Basel/CH
  • 10Medical Department, F. Hoffmann-La Roche, Ltd., Basel/CH
  • 11Global Medical Affairs, F. Hoffmann-La Roche, Ltd., Basel/CH
  • 12Gi Oncology Unit, Duke University Medical Center, 27710 - Durham/US

Abstract

Aim

Randomized controlled trials (RCTs) have demonstrated benefits in overall survival (OS) for patients (pts) with metastatic colorectal cancer (mCRC) treated with bevacizumab (BV) in the first-line setting. While RCTs have demonstrated clinical efficacy in a wide range of pts, there is a need to examine outcomes in daily clinical practice. Herein we describe results of a pooled analysis of OS according to pt subgroups from 5 observational or phase IV studies of BV in mCRC.

Methods

Pt-level data were pooled from the BRiTE (USA), ARIES (USA), BEAT (ex-USA), CONCERT (France), and AWB (Germany) studies. The majority of the studies enrolled pts with previously untreated mCRC who received BV in combination with chemotherapy and prospectively collected data on survival and safety. Using descriptive methodology, OS in the pooled dataset was evaluated in first-line pts grouped according to age (<70 y, ≥70y) and Eastern Cooperative Oncology Group performance status (ECOG PS; 0, ≥1).

Results

The dataset included 7688 pts; OS was evaluable in 7631 patients. Median age was 62.9 y (range, 18–101); 58% of pts were male; 49% had ECOG PS 0. Median OS according to age is shown in the table. Median OS was 26.9 mo for pts with ECOG PS of 0 and 18.7 mo for pts with ECOG PS of ≥1. Median OS for males and females was 22.7 mo and 22.3 mo, respectively. OS results observed in the pooled population were generally consistent with those in each study.

Conclusions

In this large, pooled population from 5 observational or phase IV studies of BV in mCRC, median OS was generally consistent with what has been shown with BV in RCTs. Consistency among subgroup OS results was observed across individual studies, despite regional differences in care likely received by patients. Additional subgroup analyses are ongoing; the dataset may be expanded to include other observational studies.

Median OS according to age subgroup

Pooled population n = 7631 BRiTE n = 1912 ARIES n = 1550 BEAT n = 1916 CONCERT n = 476 AWB n = 1777
Median OS, mo (95% CI)
<70 y 23.7 (22.9–24.5) 21.1 (19.7–22.1) 25.1 (23.0–26.9) 23.3 (22.1–24.6) 27.5 (22.7–34.3) 25.7 (24.0–27.4)
≥70 y 19.8 (18.8–20.8) 16.3 (14.8–18.0) 19.6 (17.9–21.0) 19.8 (17.5–22.0) 24.6 (19.9–32.6) 23.0 (21.2–24.9)
All patients 22.5 (22.1–23.0) 19.5 (18.3–20.5) 23.2 (21.2–24.8) 22.7 (21.6–23.7) 26.1 (22.7–30.7) 24.8 (23.7–26.1)

Disclosure

A. Grothey: Corporate-sponsored research: Genentech, Eisai, Bayer, Eli-Lilly BBI; D. Arnold: Advisory board: Roche, compensated; E. Van Cutsem: Advisory board: Roche Corporate-sponsored research: Roche, paid to university;T. Bekaii-Saab: Other substantive relationship: Consultant to Genentech;M. Kozloff: Advisory board: Roche, Genentech Other substantive relationships: Roche, Genentech; J. Bennouna: Advisory board: Roche, Boehringer Ingelheim, Novartis, Celgene;C. Revil: Stock ownership: I bought shares from Roche from 2005 until 2012 Other substantive relationships: Roche employee, Stamford consultants AG, Dornach, Switzerland; M. Donica: Other substantive relationships: Roche; N. Sommer: Stock ownership: Roche Other substantive relationships: Genentech employee; B. Leutgeb: Other substantive relationships: Roche employee;M. Ekstrand-Olsen: Other substantive relationships: Roche employee; F. Hermann: Stock ownership: Non-voting share of Roche; H. Hurwitz: Corporate-sponsored research and compensated consultant: Genentech, Inc., F. Hoffmann-La Roche, Ltd., Pfizer, Sanofi, Regeneron, Bristol-Meyers Squibb, Eli Lilly, Merck KGA, Novartis, Incite, and Threshold Compensated consultant: GSK.