Tatsuya Toyama1, Akiyo Yoshimura2, Takako Hayashi3, Naomi Kobayashi4, Kanako Saito5, Michiko Tsuneizumi6, Masataka Sawaki2, Masaya Hattori2, Takumi Nakada7, Isao Yokota8, Hiroji Iwata2. 1. 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. 2. Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. 3. Department of Breast Surgery, Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001, Japan. 4. Department of Breast Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan. 5. Department of Medical Oncology, Mie University, 2-174 Edobashi, Tsu, 514-8507, Japan. 6. Department of Breast Surgery, Shizuoka General Hospital, 4-27-1 Kita Ando, Aoi-ku, Shizuoka, 420-8527, Japan. 7. Department of Breast Surgery, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu, 500-8513, Japan. 8. Department of Biostatistics, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566, Japan.
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 worseHFS 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.
RCT Entities:
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.
Entities:
Keywords:
Breast cancer; Capecitabine; Hand–foot syndrome; Pyridoxine