| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
Symptom Management and Supportive Care |
aUniversity of California at Los Angeles (UCLA) School of Medicine, Los Angeles, California, USA; bGenentech, Inc., South San Francisco, California, USA; cCenter on Outcomes, Research and Education, Evanston Northwestern Healthcare Research Institute, Evanston, Illinois, USA; dDuke University, Durham, North Carolina, USA
Key Words. Colorectal cancer • Quality of life • Fluorouracil • Monoclonal antibodies • Bevacizumab • Angiogenesis inhibitors
Correspondence: Fairooz Kabbinavar, M.D., Division of Hematology/Oncology, UCLA School of Medicine, 10945 LeConte Avenue, Suite 2333D, Los Angeles, California 90095-7059, USA. Telephone: 310-206-3921; Fax: 310-267-0151; e-mail: fkabbina{at}mednet.ucla.edu
Received January 2, 2008; accepted for publication July 18, 2008; first published online in THE ONCOLOGIST Express on September 5, 2008.
Disclosure: Employment/leadership position: Joel F. Wallace, Genentech; Eric Holmgren, Genentech; Jing Yi, Genentech; Intellectual property rights/inventor: None; Consultant/advisory role: David Cella, Genentech; Herbert I. Hurwitz, Genentech, Roche, Sanofi-Aventis, Bristol-Myers Squibb, Exelixis; Honoraria: None; Research funding: The two bevacizumab clinical trials described in this report were sponsored by Genentech, Inc., South San Francisco, CA; analysis support was provided by Genentech, Inc., South San Francisco, CA. Ownership interest: Jing Yi, Genentech; Eric Holmgren, Genentech; Joel F. Wallace, Genentech; Expert testimony: None; Other: None. The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the authors, planners, independent peer reviewers, or staff managers.
Purpose. To compare the time to deterioration in health-related quality of life (HRQoL) in patients with previously untreated metastatic colorectal cancer receiving a 5-fluorouracil (5-FU)-based chemotherapy regimen with or without the addition of bevacizumab (BV) in two randomized, placebo-controlled studies.
Patients and Methods. Prespecified HRQoL endpoints in the phase II (Study 2192) and phase III (Study 2107) studies were time to deterioration in HRQoL, measured by the Functional Assessment of Cancer Therapy–Colorectal (FACT-C) Colorectal Cancer Subscale (CCS), Trial Outcome Index (TOI-C), and FACT-C total score. Time to deterioration in HRQoL was evaluated for patients with baseline and postbaseline assessments, using the stratified log-rank test.
Results. In the pivotal phase III trial, HRQoL baseline and postbaseline CCS scores were available for 127 patients receiving irinotecan, 5-FU, and leucovorin (LV) (IFL) and 122 patients receiving IFL plus BV. The time to deterioration in HRQoL did not differ significantly between treatment groups as measured by the CCS, TOI-C, or FACT-C total score. In the phase II study, baseline and postbaseline CCS scores were available for 77 and 89 patients receiving 5-FU and LV and 5-FU and LV plus BV, respectively. In that study, the time to deterioration in HRQoL was similar between groups as measured by the CCS and TOI-C scores, but was significantly longer in the 5-FU and LV plus BV arm than in the 5-FU and LV plus placebo arm for the FACT-C total score.
Conclusions. When added to 5-FU chemotherapy, BV significantly prolonged overall survival and progression-free survival without compromising HRQoL.
| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| THE ONCOLOGIST | STEM CELLS | CME | ALPHAMED PRESS JOURNALS |
