Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer

John P. Crown, Véronique Diéras, Elzbieta Staroslawska, Denise A. Yardley, Thomas Bachelot, Neville Davidson, Hans Wildiers, Peter A. Fasching, Olivier Capitain, Manuel Ramos, Richard Greil, Francesco Cognetti, George Fountzilas, Maria Blasinska-Morawiec, Cornelia Liedtke, Rolf Kreienberg, Wilson H. Miller, Vanessa Tassell, Xin Huang, Jolanda PaoliniKenneth A. Kern, Gilles Romieu*

*Corresponding author for this work
78 Citations (Scopus)

Abstract

Purpose: Metastatic breast cancer (MBC) remains an incurable illness in the majority of cases, despite major therapeutic advances. This may be related to the ability of breast tumors to induce neoangiogenesis, even in the face of cytotoxic chemotherapy. Sunitinib, an inhibitor of key molecules involved in neoangiogenesis, has an established role in the treatment of metastatic renal cell and other cancers and demonstrated activity in a phase II trial in MBC. We performed a randomized phase III trial comparing sunitinib plus capecitabine (2,000 mg/m2) with single-agent capecitabine (2,500 mg/m2) in patients with heavily pretreated MBC. Patients and Methods: Eligibility criteria included MBC, prior therapy with anthracyclines and taxanes, one or two prior chemotherapy regimens for metastatic disease or early relapse after a taxane plus anthracycline adjuvant regimen, and adequate organ function and performance status. The primary end point was progression-free survival, for which the study had 90% power to detect a 50% improvement (from 4 to 6 months). Results: A total of 442 patients were randomly assigned. Progression-free survival was not significantly different between the treatment arms, with medians of 5.5 months (95% CI, 4.5 to 6.0) for the sunitinib plus capecitabine arm and 5.9 months (95% CI, 5.4 to 7.6) for the capecitabine monotherapy arm (hazard ratio, 1.22; 95% CI, 0.95 to 1.58; one-sided P = .941). There were no significant differences in response rate or overall survival. Toxicity, except for hand-foot syndrome, was more severe in the combination arm. Conclusion: The addition of sunitinib to capecitabine does not improve the clinical outcome of patients with MBC pretreated with anthracyclines and taxanes.

Original languageEnglish
JournalJournal of Clinical Oncology
Volume31
Issue number23
Pages (from-to)2870-2878
Number of pages9
ISSN0732-183X
DOIs
Publication statusPublished - 10.08.2013

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