Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane

Ji Soo Park, Hei Cheul Jeung, Sun Young Rha, Joong Bae Ahn, Beodeul Kang, Hong Jae Chon, Min Hee Hong, Seungtaek Lim, Woo Ick Yang, Chung Mo Nam, Hyun Cheol Chung

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Purpose: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results: Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95 % CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.

Original languageEnglish
Pages (from-to)799-808
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Issue number4
Publication statusPublished - 2014 Aug 9


All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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