Significant Association between Hand-Foot Syndrome and Efficacy of Capecitabine in Patients with Metastatic Breast Cancer

• Azuma Yuichiro

  Division of Medicinal Safety Science, National Institute of Health Sciences

• Hata Kojiro

  Department of Pharmacy, National Cancer Center Hospital

• Sai Kimie

  Division of Medicinal Safety Science, National Institute of Health Sciences

• Udagawa Ryoko

  Department of Pharmacy, National Cancer Center Hospital

• Hirakawa Akihiro

  Department of Management Science, Tokyo University of Science

• Tohkin Masahiro

  Division of Medicinal Safety Science, National Institute of Health Sciences

• Ryushima Yasuaki

  Department of Pharmacy, National Cancer Center Hospital

• Makino Yoshinori

  Department of Pharmacy, National Cancer Center Hospital

• Yokote Nobuaki

  Department of Pharmacy, National Cancer Center Hospital

• Morikawa Norifumi

  Department of Clinical Pharmacotherapy, Graduate School of Biomedical Sciences, Hiroshima University

• Fujiwara Yasuhiro

  Department of Breast Oncology and Medical Oncology, National Cancer Center Hospital

• Saito Yoshiro

  Division of Medicinal Safety Science, National Institute of Health Sciences

• Yamamoto Hiroshi

  Department of Pharmacy, National Cancer Center Hospital

Abstract

Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), is a promising treatment for colorectal, breast and gastric cancers, but often causes hand-foot syndrome (HFS), the most common dose-limiting toxicity. The current study was conducted to investigate the relationship between HFS and efficacy of capecitabine in 98 patients with metastatic breast cancer. Possible associations between HFS and efficacy endpoints, including time-to-treatment failure (TTF), tumor response in metastatic lesions and changes in tumor markers, were investigated retrospectively using electronic medical records. The TTF of group with HFS of grade 1 and ≥2 was significantly longer than that of group with no HFS, respectively (hazard ratio (HR), 0.39; 95% confidence interval (CI), 0.18–0.87 for group with grade 1; HR, 0.42, 95% CI, 0.19–0.90 for group with grade ≥2). Significantly higher disease control rates for the liver metastasis were observed in patients with HFS (grade 1 and greater) than in those without HFS (92.9 vs. 42.9%, p=0.009). Furthermore, prevention of increases in tumor marker levels (carcinoembryonic antigen (CEA), carbohydrate antigen 15-3 (CA15-3) and National Cancer Center-Stomach-439 (NCC-ST439)) was evident in patients with HFS. This study clearly showed a significant correlation between HFS and some efficacy markers of capecitabine therapy in patients with metastatic breast cancer, and suggests that early dose adjustment based on severity of HFS might improve efficacy. Studies are needed to explore predictive biomarkers for HFS/efficacy, so that capecitabine therapy can be further tailored to patient response.

Journal

• Biological and Pharmaceutical Bulletin

  Biological and Pharmaceutical Bulletin 35 (5), 717-724, 2012

  The Pharmaceutical Society of Japan

Keywords

• capecitabine
• hand-foot syndrome
• efficacy
• electronic medical record

Details

• CRID: 1390001204634490624
• NII Article ID: 130001872230
• NII Book ID: AA10885497
• DOI: 10.1248/bpb.35.717
• COI: 1:STN:280:DC%2BC38jgslemsw%3D%3D
• ISSN: 13475215
• ISSN: 09186158
• NDL BIB ID: 023592895
• PubMed: 22687407
• Web Site: http://id.ndl.go.jp/bib/023592895
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I023592895
• Web Site: https://www.jstage.jst.go.jp/article/bpb/35/5/35_5_717/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2012324470
• Text Lang: en
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed