Originally published as JCO Early Release 10.1200/JCO.2008.17.7931 on December 8 2008

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Addition of Bevacizumab to Fluorouracil-Based First-Line Treatment of Metastatic Colorectal Cancer: Pooled Analysis of Cohorts of Older Patients From Two Randomized Clinical Trials

Fairooz F. Kabbinavar, Herbert I. Hurwitz, Jing Yi, Somnath Sarkar, Oliver Rosen

From the University of California at Los Angeles, Los Angeles; Genentech Inc, South San Francisco, CA; and Duke University, Durham, NC

Corresponding author: Fairooz F. Kabbinavar, MD, Department of Medicine, Division of Hematology & Oncology, University of California at Los Angeles, 2333D PVUB MC 705907, 10945 Le Conte Ave, Los Angeles, CA 90095-7059; e-mail: fkabbina{at}mednet.ucla.edu

Purpose Colorectal cancer (CRC) occurs predominantly in older persons. To provide more statistical power to assess risk/benefit in older patients, we examined the clinical benefit of bevacizumab (BV) plus fluorouracil-based chemotherapy in first-line metastatic CRC (mCRC) treatment in patients aged 65 years, using data pooled from two placebo-controlled studies.

Patients and Methods Pooled efficacy data for 439 patients 65 years old randomized to BV plus chemotherapy (n = 218) or placebo plus chemotherapy (n = 221) in study 1 and study 2 were retrospectively analyzed on an intent-to-treat basis for overall survival (OS), progression-free survival (PFS), and objective response. Safety analysis was based on reports of targeted adverse events in treated patients.

Results Median OS with BV plus chemotherapy was 19.3 v 14.3 months with placebo plus chemotherapy (hazard ratio [HR] = 0.70; 95% CI, 0.55 to 0.90; P = .006). Patients treated with BV plus chemotherapy had a median PFS of 9.2 v 6.2 months for placebo plus chemotherapy patients (HR = 0.52; 95% CI, 0.40 to 0.67; P < .0001). The objective response rate was 34.4% with BV plus chemotherapy versus 29.0% with placebo plus chemotherapy (difference not statistically significant). Rates of BV-associated adverse events in the pooled BV plus chemotherapy group were consistent with those reported in the overall populations for the two studies.

Conclusion Analysis of pooled patient cohorts age 65 years from two similar trials in mCRC indicates that adding bevacizumab to fluorouracil-based chemotherapy improved OS and PFS, similar to the benefits in younger patients. Also, the risks of treatment do not seem to exceed those in younger patients with mCRC.

published online ahead of print at www.jco.org on December 8, 2008

Supported by Genentech.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00109070 [ClinicalTrials.gov] and NCT00109226 [ClinicalTrials.gov]

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