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Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study)

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Abstract

Goals of work

The aim of this study was to prospectively evaluate chemotherapy-induced peripheral neuropathy (CIPN) using a patient-based instrument, the Patient Neurotoxicity Questionnaire (PNQ) and a physician-based instrument, the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) in patients with advanced or metastatic breast cancer who were treated with weekly paclitaxel.

Materials and methods

CIPN symptoms were prospectively assessed in 35 patients using the PNQ, NCI-CTC, and the Functional Assessment of Cancer Therapy (FACT)-Taxane including neurotoxicity component (Ntx) at the baseline, and 8 and 16 weeks after starting chemotherapy.

Results

For sensory neuropathy symptoms, the reported incidence of CIPN was significantly increased during active treatment in terms of both the PNQ and NCI-CTC assessments. In contrast, there was a notable increase of patient motor neuropathy symptoms that were elucidated only by the PNQ. The PNQ grades of CIPN were widely distributed in the patient population as compared with the NCI-CTC grades for both sensory and motor neuropathy. The sensory PNQ grade was correlated with sensory NCI-CTC grade (r = 0.58) and Ntx (r = 0.51), and the motor PNQ grade was correlated with Ntx (r = 0.57).

Conclusions

The PNQ appears to be more sensitive and responsive than the NCI-CTC for CIPN; the PNQ appears to have diagnostic validity for evaluating CIPN in patients who are receiving neurotoxic chemotherapy.

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Acknowledgments

We would like to thank all patients and physicians who participated in this study, and Miss Yumiko Nomura of J-CRSU for her assistance with data management. This study was supported by the CSPOR and Comprehensive Support Project for Health Outcomes Research (CSP-HOR) developed by the Public Health Research Foundation, Tokyo, Japan.

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Authors and Affiliations

  1. Department of Surgery, Division of Clinical Trials and Research, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan

    Katsumasa Kuroi

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

    Kojiro Shimozuma

  3. Department of Biostatistics, School of Public Health, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654, Japan

    Yasuo Ohashi, Ayano Takeuchi & Toshihiko Aranishi

  4. Department of Surgery, Hiroshima City Asa Hospital, 2-1-1 Kabeminami, Asakita-ku, Hiroshima, 731-0293, Japan

    Kazufumi Hisamatsu

  5. Department of Surgery, Osaka National Hospital, 2-1-14, Honenzaka, Chuou-ku, Osaka, 540-0006, Japan

    Norikazu Masuda

  6. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, 54-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan

    Satoshi Morita

  7. Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemotocho, Matsuyama, Ehime, 791-0280, Japan

    Shozo Ohsumi

  8. BioNumerik Pharmaceuticals, Inc, Suite 1250, 8122 Datapoint Drive, San Antonio, TX, 78229, USA

    Frederick H. Hausheer

Authors
  1. Katsumasa Kuroi
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  2. Kojiro Shimozuma
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  3. Yasuo Ohashi
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  4. Kazufumi Hisamatsu
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  5. Norikazu Masuda
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  6. Ayano Takeuchi
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  7. Toshihiko Aranishi
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  8. Satoshi Morita
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  9. Shozo Ohsumi
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  10. Frederick H. Hausheer
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Corresponding author

Correspondence to Katsumasa Kuroi.

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Kuroi, K., Shimozuma, K., Ohashi, Y. et al. Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer 17, 1071–1080 (2009). https://doi.org/10.1007/s00520-008-0550-x

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  • DOI: https://doi.org/10.1007/s00520-008-0550-x

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