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

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Abstract

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.

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Conflict of interest

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Authors and Affiliations

  1. Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea

    Ji Soo Park, Sun Young Rha, Joong Bae Ahn, Beodeul Kang, Hong Jae Chon, Min Hee Hong, Seungtaek Lim & Hyun Cheol Chung

  2. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea

    Ji Soo Park, Hei-Cheul Jeung, Sun Young Rha, Joong Bae Ahn, Beodeul Kang, Hong Jae Chon, Min Hee Hong, Seungtaek Lim & Hyun Cheol Chung

  3. Division of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Seoul, South Korea

    Hei-Cheul Jeung

  4. Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, South Korea

    Ji Soo Park, Hei-Cheul Jeung, Sun Young Rha, Joong Bae Ahn, Beodeul Kang, Hong Jae Chon, Min Hee Hong, Seungtaek Lim & Hyun Cheol Chung

  5. Department of Pathology, Yonsei University College of Medicine, Seoul, South Korea

    Woo Ick Yang

  6. Department of Biostatistics, Yonsei University College of Medicine, Seoul, South Korea

    Chung Mo Nam

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  1. Ji Soo Park
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  11. Hyun Cheol Chung
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Correspondence to Hyun Cheol Chung.

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Park, J.S., Jeung, HC., Rha, S.Y. et al. Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane. Cancer Chemother Pharmacol 74, 799–808 (2014). https://doi.org/10.1007/s00280-014-2551-4

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  • DOI: https://doi.org/10.1007/s00280-014-2551-4

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