Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 4523
© 2006 American Society of Clinical Oncology

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Abstract

Bevacizumab with or without erlotinib in metastatic renal cell carcinoma (RCC)

Cleveland Clinic Taussig Cancer Center, Cleveland, OH; University of California at Los Angeles, Los Angeles, CA; University of Pennsylvania, Philadelphia, PA; Stanford University Medical Center, Stanford, CA; Wayne State University, Detroit, MI; University of Colorado Health Sciences Center, Aurora, CO; Our Lady of Mercy Medical Center, Bronx, NY; Genentech, Inc., South San Francisco, CA; Beth Israel Deaconess Medical Center, Boston, MA

4523

Background: Bevacizumab (B) has clinical efficacy in metastatic RCC following cytokine treatment. A single-arm Phase II trial suggested potential clinical benefit of adding erlotinib (E) to B. To further assess this combination in RCC, we conducted a multicenter, randomized, double-blind Phase 2 trial comparing B+E vs B + placebo. Methods: Eligibility criteria included: previously untreated metastatic RCC with >50% clear cell histology; previous nephrectomy; ECOG PS 0 or 1; measurable disease; serum Ca++ 10 mg/dL; LDH 1.5 ULN; Hgb 9 g/dL; and standard exclusion criteria for B. All pts received B 10 mg/kg IV q 2 wk with either E 150 mg po daily or placebo until disease progression or unacceptable toxicity. Tumors were assessed using RECIST every 8 wks. A landmark analysis was performed 9 mo after accrual of the last pt. Objective response rate (ORR) and progression-free survival (PFS) were co-primary endpoints. Secondary endpoints included response duration, overall survival, and safety. Results: 104 pts (53 B, 51 B+E) were enrolled at 20 sites from Mar 2004–Oct 2004. 65 pts have discontinued therapy. 55 have progressed (PFS HR = 0.86, CI 0.5, 1.49). Median follow-up was 9.8 mo. Median survival duration was not reached. Only 1 treatment-related death due to GI perforation occurred (on B+E). Updated safety and survival data will be presented. Conclusions: B+E and B were well tolerated. Adding E does not appear to improve efficacy from B. PFS of 8.5 months with B compares favorably with the historical PFS of 4.7 mo with interferon alpha (IFN). Results of phase III trials comparing IFN ± B are pending.

Abstract presentation from the 2006 ASCO Annual Meeting