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- W5038423 abstract "895 Background: The objective of this phase II study is to determine the efficacy and safety of the combination chemotherapy of gemcitabine and capecitabine, in patients with MBC previously treated with anthracycline- and taxane-containing regimens. Methods: Eligibility criteria included MBC with previous exposure to anthracycline and taxane; performance status (ECOG criteria) 0–2; age ≥ 20; adequate cardiac, pulmonary, hepatic, renal and bone marrow functions. Patients were given intravenous gemcitabine 1,000 mg/m2 (days 1 and day 8) and oral capecitabine 1,000 mg/m2 twice daily (days 1–14) every 3 weeks. According to Simon’s two stage phase II design, it was planned to enroll 48 patients hoping 40% response rate unless the study had to be terminated early due to poor response rate (≤3/13) at the first stage evaluation. Results: Between Mar. 2003 and Feb. 2004, a total of 14 patients received 73 cycles of treatment (median, 5 cycles/patient). Twelve patients received this regimen as a second-line treatment, and two as a third-line treatment for MBC. At the first stage evaluation, the response rate was 21.4% (95% CI, 0∼42.8%) in the intention-to-treat population (partial response 3, stable disease 5, progressive disease 5, not evaluated 1). The median response duration was 4.3 months (range, 2.1∼4.7+ months). Considering responders and patients with stable disease persisting more than 6 months, the clinical benefit rate was 42.9%. With a median follow-up of 10 months, median progression-free survival was 4.2 months (range, 1∼8.4+ months). Toxicities included grade III/IV neutropenia in 26% and 3%, and grade II/III hand-foot syndrome in 19% and 6% of cycles, respectively. Other non-hematologic toxicities were minimal and manageable. The median dose intensity of gemcitabine and capecitabine was 95.8% (range, 54∼100%), and 100% (range, 75∼100%), respectively. Conclusions: Although the combination of gemcitabine and capecitabine was well tolerated, its activity was less than expected in MBC patients previously treated with both anthracyclines and taxanes. Thus, this study had to be terminated early as planned. No significant financial relationships to disclose." @default.
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- W5038423 date "2005-06-01" @default.
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- W5038423 title "Phase II study of gemcitabine and capecitabine in patients with metastatic breast cancer pretreated with anthracyclines and taxanes" @default.
- W5038423 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.895" @default.
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