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Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial

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Abstract

Purpose

To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node-positive breast cancer patients treated with taxane-containing regimens.

Methods

We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline–cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX.

Results

PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P = .003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P = .669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments.

Conclusions

Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable.

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Acknowledgments

We thank all the patients, investigators, and clinical research specialists who participated in this study. We also thank Ms. Michiko Kato and Ms. Yumiko Nomura for their helpful assistance in creating this study report.

Conflict of interest

This study was funded by the Comprehensive Support Project for Oncology Research (CSPOR) and for Health Outcomes Research (CSP-HOR) of the Public Health Research Foundation (PHRF; Tokyo, Japan). All corporate and personal sources of financial support to PHRF are listed in the CSPOR website (http://www.csp.or.jp/cspor/kyousan.html). The pharmaceutical manufacturers/distributors who had provided financial contribution as a corporate sponsor took no part in this study other than providing information relevant to proper use of the study drugs. All decisions concerning the planning, implementation, and publication of this study were made by the executive committee of this study. I certify that I have no conflict of interest relevant to this manuscript.

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Authors and Affiliations

  1. Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, 1-1-1 Noji-Higashi, Kusatsu, Shiga, 525-8577, Japan

    Kojiro Shimozuma

  2. Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan

    Yasuo Ohashi, Ayano Takeuchi & Toshihiko Aranishi

  3. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan

    Satoshi Morita

  4. Division of Clinical Trials and Research, Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan

    Katsumasa Kuroi

  5. Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

    Shozo Ohsumi

  6. Division of Breast Oncology, Niigata City General Hospital, Niigata, Japan

    Haruhiko Makino

  7. Breast and Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan

    Noriyuki Katsumata

  8. Kitasato University Hospital, Sagamihara, Kanagawa, Japan

    Masaru Kuranami

  9. Saitama Cancer Center, Saitama, Japan

    Kimito Suemasu

  10. Arche Clinic, Saitama, Japan

    Kimito Suemasu

  11. Hamamatsu Oncology Center, Hamamatsu, Shizuoka, Japan

    Toru Watanabe

  12. BioNumerik Pharmaceuticals Inc., San Antonio, TX, USA

    Frederick H. Hausheer

Authors
  1. Kojiro Shimozuma
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  2. Yasuo Ohashi
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  3. Ayano Takeuchi
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  4. Toshihiko Aranishi
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  5. Satoshi Morita
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  6. Katsumasa Kuroi
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  7. Shozo Ohsumi
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  8. Haruhiko Makino
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  9. Noriyuki Katsumata
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  10. Masaru Kuranami
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  11. Kimito Suemasu
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  12. Toru Watanabe
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  13. Frederick H. Hausheer
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Corresponding author

Correspondence to Kojiro Shimozuma.

Additional information

This study was presented in part at the 27th San Antonio Breast Cancer Symposium, Dec. 8–11, 2004, San Antonio and the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2–6, 2006, Atlanta.

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Shimozuma, K., Ohashi, Y., Takeuchi, A. et al. Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial. Support Care Cancer 20, 3355–3364 (2012). https://doi.org/10.1007/s00520-012-1492-x

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  • DOI: https://doi.org/10.1007/s00520-012-1492-x

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