NO USE OF SUNITINIB IN COLORECTAL CANCER

J Clin Oncol. 2013 Jul 15. [Epub ahead of print]

Phase III Trial of Sunitinib in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Patients With Pretreated Metastatic Breast Cancer.

Crown JP, Diéras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G,Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G.

Source

John P. Crown, Irish Cooperative Oncology Research Group, Dublin, Ireland; Véronique Diéras, Institut Curie, Paris; Thomas Bachelot, Centre Léon Bérard, Lyon; Olivier Capitain, Centre Paul Papin, Angers; Gilles Romieu, Regional Centre for the Fight Against Cancer Val d'Aurelle Paul-Lamarque, Montpellier, France; Elzbieta Staroslawska, Centrum Onkologii Ziemi Lubelskiej, Lublin; Maria Blasinska-Morawiec, Wojewodzki Szpital Specjalistyczny, im M. Kopernika, Lodz, Poland; Denise A. Yardley, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN; Neville Davidson, Broomfield Hospital, Chelmsford, United Kingdom; Hans Wildiers, Universitair Ziekenhuis (UZ) Gasthuisberg, UZ Leuven, Leuven, Belgium; Peter A. Fasching, Frauenklinik des Universitätsklinikums Erlangen, Erlangen; Cornelia Liedtke, Universitätsklinikum Münster, Münster; Rolf Kreienberg, Universitätsfrauenklinik Ulm, Ulm, Germany; Manuel Ramos, Centro Oncologico de Galicia, La Coruña, Spain; Richard Greil, Paracelsus Medical University Salzburg, Salzburg, Austria; Francesco Cognetti, Istituto Regina Elena, Rome; Jolanda Paolini, Pfizer Oncology, Milan, Italy; George Fountzilas, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Wilson H. Miller Jr, Segal Cancer Centre of Jewish General Hospital, McGill University, Montreal, Quebec, Canada; and Vanessa Tassell, Xin Huang, and Kenneth A. Kern, Pfizer Oncology, La Jolla, CA.

Abstract

PURPOSEMetastatic 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 METHODSEligibility 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).ResultsA 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. CONCLUSIONThe addition of sunitinib to capecitabine does not improve the clinical outcome of patients with MBC pretreated with anthracyclines and taxanes.