Originally published as JCO Early Release 10.1200/JCO.2009.21.2795 on March 2 2009

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In Reply

Mayo Clinic, Rochester, MN

Mark Kozloff

Monroe Medical Associates, Harvey, IL

We appreciate Drs Kopetz and Abbruzzese's comments on the value of observational cohort studies in general and the analysis of bevacizumab beyond progression (BBP) in the Bevacizumab Regimens: Investigation of Treatment Effects and Safety (BRiTE) study in particular.¹ As outlined in our paper, we agree that the association between outcome and BBP could have potentially been influenced by several factors not captured in our study. We do note that the effect of BBP on improved survival was strongly maintained in a detailed multivariate analysis, which included outcome of first-line therapy as well as postprogression treatment, and a landmark analysis. In addition, this effect was presented in a physician-based (as opposed to patient-based) analysis of propensity to use or not use bevacizumab beyond progression. In particular, in the multivariate analysis, neither the postprogression use of epidermal growth factor receptor inhibitors, or exposure to additional chemotherapy agents (both of which may be markers expected to identify patients with the fewest comorbidities and best performance status), were associated with survival. Moreover, the BBP and no-BBP groups exhibited similar response rates and time to progression in first-line therapy. We agree with Drs Kopetz and Abbruzzese that the magnitude of benefit associated with BBP in BRiTE, a difference of almost 12 months in overall survival, clearly warrants and requires confirmation in a prospective randomized phase III trial. Randomized trials evaluating BBP in colorectal and breast cancer are underway or planned in the United States and Europe, and we strongly support these trials. Until the results of these trials are available, oncologists will have to cautiously and critically review the results presented in our paper to inform their decision regarding the use of BBP as a treatment paradigm in their clinical practice.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Axel Grothey, Genentech (C), Sanofi-aventis (C), Bristol-Myers Squibb (C); Daniel J. Sargent, Genentech (C), Roche (C), Sanofi-aventis (C); Mark Kozloff, Genentech (C), Pfizer (C) Stock Ownership: None Honoraria: Axel Grothey, Genentech, Sanofi-aventis, Bristol-Myers Squibb; Daniel J. Sargent, Genentech, Roche, Sanofi-aventis; Mark Kozloff, Genentech, Pfizer, Sanofi-aventis Research Funding: Axel Grothey, Genentech, Sanofi-aventis, Bristol-Myers Squibb Expert Testimony: None Other Remuneration: None

REFERENCE

1. Grothey A, Sugrue MM, Purdie DM, et al: Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: Results from a large observational cohort study (BRiTE). J Clin Oncol 26:5326–5334, 2008.[Abstract/Free Full Text]

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