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Data do not support sunitinib/capecitabine combo for advanced breast cancer
ASCO 2010 Annual Meeting
CHICAGO — A phase 3 clinical trial failed to demonstrate the superiority of treatment using sunitinib plus capecitabine compared with capecitabine alone for patients with previously treated advanced breast cancer.
John Crown, MD, consultant medical oncologist at St Vincent’s Hospital in Dublin, presented data from the trial, which sought to investigate the antiangiogenic agent, sunitinib (Sutent, Pfizer), in combination with chemotherapy.
Patients were randomly assigned sunitinib plus capecitabine (n=221) or capecitabine alone (n=221). The two arms were equally balanced for all eligibility criteria. Endpoints were PFS, overall response rate, OS, quality of life and safety.
Median PFS for the sunitinib/capecitabine arm was 5.5 months vs. 5.9 months for the capecitabine arm (HR=1.224; 95% CI, 0.95-1.58). Median OS for the sunitinib/capecitabine arm was 16.4 months vs. 16.5 months for the capecitabine arm (HR=0.995; 95% CI, 0.76-1.3). Overall response rate was 18.6% for the combination arm vs. 16.3% for the capecitabine arm.
“In general, hematologic toxicity was more frequent and severe in the combination arm of the study,” Crown said.
Non-hematologic toxicity was more common and high grade in the combination arm, he said.
“Some toxicities resulted in treatment discontinuation or modification of dose,” he said. In the combination arm, 48% of patients had treatment discontinuation and 80% had dosing modification; in the capecitabine alone arm, it was 18% and 66%, respectively.
Crown reported that the study did not meet its primary endpoint and that sunitinib plus capecitabine is not recommended for second- or third-line treatment. –by Joan-Marie Stiglich, ELS
For more information:
- Crown J. #LBA1011. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.
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