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A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer

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Summary

Background

This multicenter phase II study was conducted to evaluate the response and safety of a combination of docetaxel plus doxorubicin as neoadjuvant therapy for stage II, III breast cancer.

Methods

Patients with stage II or III breast cancer underwent three cycles of neoadjuvant chemotherapy with doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 every 3 weeks followed by curative surgery. Prophylactic GCSF was not used.

Results

Ninety patients were enrolled in the study and 86 were evaluable for efficacy. The median age was 43 years (range, 30–69). The mean relative dose intensity was 0.98 for docetaxel and 0.98 for doxorubicin. Breast-conserving surgery was performed in 12 (13.7%) patients. The clinical overall response rate was 86% and pathologic complete response was 10.5%. Grade 3/4 neutropenia was observed in 26% of total 258 cycles and febrile neutropenia was observed in 15.8%. Pneumonia was observed in one patient and grade 3 mucositis was observed in three patients.

Conclusion

Docetaxel and doxorubicin was an effective and well-tolerated neoadjuvant chemotherapy for stage II and III breast cancer. Clinical benefit of this treatment will be confirmed by survival data with long term follow up.

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Acknowledgement

This work was partially supported by the research grant from the Korean Breast Cancer Foundation.

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Authors and Affiliations

  1. Division of Breast Oncology, Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Republic of Korea

    Sehwan Han, Sung Bae Kim, Sook-Hyun Lim & Hee-Suk Park

  2. Department of Medicine, Asan Medical Center, Sangpagu, Seoul, Korea

    Sehwan Han

  3. Department of Surgery, Samsung Cheil Hospital, Sungkyunkwan University School of Medicine, Kangnam, Seoul, Korea

    Sung S. Kang

  4. Department of Surgery, Korea Cancer Center Hospital, Seoul, Korea

    Woo C. Noh & Nam S. Paik

  5. Chungnam National University Hospital, Taejon, Korea

    Eil S. Chang &  Jae-Ryong Kim

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  1. Sehwan Han
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  2. Sung Bae Kim
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Correspondence to Sehwan Han.

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Han, S., Kim, S.B., Kang, S.S. et al. A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer. Breast Cancer Res Treat 98, 57–61 (2006). https://doi.org/10.1007/s10549-005-9131-6

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  • DOI: https://doi.org/10.1007/s10549-005-9131-6

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