title: [Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer(JO19380)].
abstract: FOLFOX plus Bevacizumab (BEV) is one of he current standard treatments for unresectable colorectal cancer. In Europe and the United States, XELOX is a regimen which replaced 5-FU/LV of FOLFOX with capecitabine (XEL), an oral prodrug of fluorouracil. Benefits of XELOX and FOLFOX are reported to be same in Europe and United States. XELOX + BEV is recommended as treatment option in various guidelines. However, the safety and effectiveness data were from overseas and unconfirmed in Japan. Therefore, we carried out a JO19380 study to evaluate the effectiveness and safety XELOX + BEV on Japanese patients in a domestic phase I/II clinical trial. A total of 64 patients were registered in this study. The response rate was 72%, the progression free survival was 11 months, and the median survival time was 27.4 months with XELOX + BEV. The common grade 3/4 toxicities were sensory neurotoxicity (17%) and neutropenia (16%). The effectiveness and safety equivalents of overseas reports were confirmed in Japanese patients. They suggested that XELOX + BEV has the potential to become one of the standard treatments for unresectable colorectal cancer in Japan. In the trial, long-term disease control with XEL-BEV was reported in patients who discontinued oxaliplatin because of adverse events. Continuous treatment with XEL + BEV after XELOX + BEV is considered to be significant first-line therapy for colorectal cancer based on that report.
authors.affiliation: Showa University School of Medicine, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sato
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Doi
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hamamoto
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Mizunuma
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takiuchi
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D010071:Oxaloacetates
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D010071:Oxaloacetates; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil