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A randomized phase II study evaluating pyridoxine for the prevention of hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer.
Breast Cancer 2018; 25(6):729-735BC

Abstract

BACKGROUND

Pyridoxine, an activated form of vitamin B6 used to treat allergic dermatitis, may prevent capecitabine-associated hand-foot syndrome (HFS), although evidence of the benefit of prophylactic pyridoxine is lacking. The aim of this open-label, multicenter, randomized phase II study was to determine whether prophylactic pyridoxine could delay the onset of capecitabine-induced HFS in patients with advanced or metastatic breast cancer.

METHODS

Patients received either concomitant pyridoxine (60 mg per day; pyridoxine group), or no pyridoxine but treatment with capecitabine-containing regimens (no pyridoxine group). Study treatment was administered until the development of grade 2 or worse HFS or disease progression. The primary endpoint was the time to onset of grade 2 or worse HFS from the start of protocol treatment.

RESULTS

A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively [hazard ratio = 0.75 (80% confidence interval 0.50-1.13), one-sided P = 0.18].

CONCLUSIONS

Prophylactic pyridoxine was not shown to have an effect on the onset of capecitabine-associated HFS in this study.

Authors+Show Affiliations

Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. t.toyama@med.nagoya-cu.ac.jp.Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.Department of Breast Surgery, Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001, Japan.Department of Breast Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan.Department of Medical Oncology, Mie University, 2-174 Edobashi, Tsu, 514-8507, Japan.Department of Breast Surgery, Shizuoka General Hospital, 4-27-1 Kita Ando, Aoi-ku, Shizuoka, 420-8527, Japan.Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.Department of Breast Surgery, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu, 500-8513, Japan.Department of Biostatistics, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566, Japan.Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29948956

Citation

Toyama, Tatsuya, et al. "A Randomized Phase II Study Evaluating Pyridoxine for the Prevention of Hand-foot Syndrome Associated With Capecitabine Therapy for Advanced or Metastatic Breast Cancer." Breast Cancer (Tokyo, Japan), vol. 25, no. 6, 2018, pp. 729-735.
Toyama T, Yoshimura A, Hayashi T, et al. A randomized phase II study evaluating pyridoxine for the prevention of hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer. Breast Cancer. 2018;25(6):729-735.
Toyama, T., Yoshimura, A., Hayashi, T., Kobayashi, N., Saito, K., Tsuneizumi, M., ... Iwata, H. (2018). A randomized phase II study evaluating pyridoxine for the prevention of hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer. Breast Cancer (Tokyo, Japan), 25(6), pp. 729-735. doi:10.1007/s12282-018-0879-z.
Toyama T, et al. A Randomized Phase II Study Evaluating Pyridoxine for the Prevention of Hand-foot Syndrome Associated With Capecitabine Therapy for Advanced or Metastatic Breast Cancer. Breast Cancer. 2018;25(6):729-735. PubMed PMID: 29948956.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized phase II study evaluating pyridoxine for the prevention of hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer. AU - Toyama,Tatsuya, AU - Yoshimura,Akiyo, AU - Hayashi,Takako, AU - Kobayashi,Naomi, AU - Saito,Kanako, AU - Tsuneizumi,Michiko, AU - Sawaki,Masataka, AU - Hattori,Masaya, AU - Nakada,Takumi, AU - Yokota,Isao, AU - Iwata,Hiroji, Y1 - 2018/06/08/ PY - 2018/02/02/received PY - 2018/06/06/accepted PY - 2018/6/28/pubmed PY - 2019/3/21/medline PY - 2018/6/28/entrez KW - Breast cancer KW - Capecitabine KW - Hand–foot syndrome KW - Pyridoxine SP - 729 EP - 735 JF - Breast cancer (Tokyo, Japan) JO - Breast Cancer VL - 25 IS - 6 N2 - BACKGROUND: Pyridoxine, an activated form of vitamin B6 used to treat allergic dermatitis, may prevent capecitabine-associated hand-foot syndrome (HFS), although evidence of the benefit of prophylactic pyridoxine is lacking. The aim of this open-label, multicenter, randomized phase II study was to determine whether prophylactic pyridoxine could delay the onset of capecitabine-induced HFS in patients with advanced or metastatic breast cancer. METHODS: Patients received either concomitant pyridoxine (60 mg per day; pyridoxine group), or no pyridoxine but treatment with capecitabine-containing regimens (no pyridoxine group). Study treatment was administered until the development of grade 2 or worse HFS or disease progression. The primary endpoint was the time to onset of grade 2 or worse HFS from the start of protocol treatment. RESULTS: A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively [hazard ratio = 0.75 (80% confidence interval 0.50-1.13), one-sided P = 0.18]. CONCLUSIONS: Prophylactic pyridoxine was not shown to have an effect on the onset of capecitabine-associated HFS in this study. SN - 1880-4233 UR - https://www.unboundmedicine.com/medline/citation/29948956/A_randomized_phase_II_study_evaluating_pyridoxine_for_the_prevention_of_hand_foot_syndrome_associated_with_capecitabine_therapy_for_advanced_or_metastatic_breast_cancer_ L2 - https://dx.doi.org/10.1007/s12282-018-0879-z DB - PRIME DP - Unbound Medicine ER -