Please use this identifier to cite or link to this item: https://doi.org/10.1007/s10549-010-0788-0
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dc.titlePhase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer
dc.contributor.authorBarrios, C.H.
dc.contributor.authorLiu, M.-C.
dc.contributor.authorLee, S.C.
dc.contributor.authorVanlemmens, L.
dc.contributor.authorFerrero, J.-M.
dc.contributor.authorTabei, T.
dc.contributor.authorPivot, X.
dc.contributor.authorIwata, H.
dc.contributor.authorAogi, K.
dc.contributor.authorLugo-Quintana, R.
dc.contributor.authorHarbeck, N.
dc.contributor.authorBrickman, M.J.
dc.contributor.authorZhang, K.
dc.contributor.authorKern, K.A.
dc.contributor.authorMartin, M.
dc.date.accessioned2014-11-26T09:59:59Z
dc.date.available2014-11-26T09:59:59Z
dc.date.issued2010-05
dc.identifier.citationBarrios, C.H., Liu, M.-C., Lee, S.C., Vanlemmens, L., Ferrero, J.-M., Tabei, T., Pivot, X., Iwata, H., Aogi, K., Lugo-Quintana, R., Harbeck, N., Brickman, M.J., Zhang, K., Kern, K.A., Martin, M. (2010-05). Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Research and Treatment 121 (1) : 121-131. ScholarBank@NUS Repository. https://doi.org/10.1007/s10549-010-0788-0
dc.identifier.issn01676806
dc.identifier.urihttp://scholarbank.nus.edu.sg/handle/10635/110766
dc.description.abstractThis multicenter, randomized, open-label phase III trial (planned enrollment: 700 patients) was conducted to test the hypothesis that single-agent sunitinib improves progression-free survival (PFS) compared with capecitabine as treatment for advanced breast cancer (ABC). Patients with HER2-negative ABC that recurred after anthracycline and taxane therapy were randomized (1:1) to sunitinib 37.5 mg/day or capecitabine 1,250 mg/m2 (1,000 mg/m 2 in patients >65 years) BID on days 1-14 q3w. The independent data-monitoring committee (DMC) determined during the first interim analysis (238 patients randomized to sunitinib, 244 to capecitabine) that the trial be terminated due to futility in reaching the primary endpoint. No statistical evidence supported the hypothesis that sunitinib improved PFS compared with capecitabine (one-sided P = 0.999). The data indicated that PFS was shorter with sunitinib than capecitabine (median 2.8 vs. 4.2 months, respectively; HR, 1.47; 95% CI, 1.16-1.87; two-sided P = 0.002). Median overall survival (15.3 vs. 24.6 months; HR, 1.17; two-sided P = 0.350) and objective response rates (11 vs. 16%; odds ratio, 0.65; P = 0.109) were numerically inferior with sunitinib versus capecitabine. While no new or unexpected safety findings were reported, sunitinib treatment was associated with higher frequencies and greater severities of many common adverse events (AEs) compared with capecitabine, resulting in more temporary discontinuations due to AEs with sunitinib (66 vs. 51%). The relative dose intensity was lower with sunitinib than capecitabine (73 vs. 95%). Based on these efficacy and safety results, sunitinib should not be used as monotherapy for patients with ABC. © 2010 Springer Science+Business Media, LLC.
dc.description.urihttp://libproxy1.nus.edu.sg/login?url=http://dx.doi.org/10.1007/s10549-010-0788-0
dc.sourceScopus
dc.subjectAdvanced breast cancer
dc.subjectCapecitabine
dc.subjectSunitinib malate
dc.subjectTyrosine kinase inhibitor
dc.typeArticle
dc.contributor.departmentCANCER SCIENCE INSTITUTE OF SINGAPORE
dc.description.doi10.1007/s10549-010-0788-0
dc.description.sourcetitleBreast Cancer Research and Treatment
dc.description.volume121
dc.description.issue1
dc.description.page121-131
dc.description.codenBCTRD
dc.identifier.isiut000276758200012
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