title: Bi-weekly Capecitabine-Oxaliplatin (XELOX) plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer -The PHOENiX Trial.
abstract: OBJECTIVE
  This phase II study assessed the efficacy and toxicity of an intermittent weekly capecitabine regimen in combination with oxaliplatin (XELOX) plus bevacizumab as a first-line treatment of metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Patients with measurable mCRC who were to receive first-line chemotherapy were enrolled onto this disease-oriented multicenter phase II trial. Patients with mCRC were required to have Eastern Cooperative Oncology Group performance status of 0 to 1, to be aged >20 years, and to have adequate organ function. Localization of tumor, toxicities, response rate, progression-free survival (PFS) and time to progression (TTP) were studied. Capecitabine dose was 2,500 mg/m(2)/day on days 1-7 (n=47) and was increased to 3,000 mg/m(2)/day (n=5) in combination with oxaliplatin (85 mg/m(2)) and bevacizumab (5 mg/kg), repeated every 2 weeks.
  
  
  RESULTS
  A total of 51 patients were enrolled from 14 institutions from December 2011 to July 2012. The median age was 66 (range=38-85) years, 29 (56.9%) had colonic cancer and 22 (43.1%) had rectal cancer in this study. Pertinent grade 3/4 toxicities were neutropenia (13.7%), peripheral neuropathy (13.7%), hypertension (13.7%), gastrointestinal perforation (3.9%), and hand-foot syndrome (5.9%). The response rate was 51% (one complete and 25 partial responses). Median PFS and TTP were 344 days and 196 days, respectively. Median overall survival has not been reached yet.
  
  
  CONCLUSIONS
  The first-line treatment of mCRC using a biweekly combination of XELOX plus bevacizumab can also be administered safely and effectively in Japan. It is suggested that this regimen is an appropriate option for the treatment of mCRC.
authors.affiliation: Surgery, Aichi cancer center, Aichi Hospital, Kuriyado Kakemachi, Okazaki City, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Matsui
authors.affiliation: Kitakyushu General Hospital, Kitakyushu, Japan n-nagata@kitakyu-hp.or.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Nagata
authors.affiliation: Department of Surgery 1, University of Occupational and Environmental Health, Fukuoka, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Hirata
authors.affiliation: Department of Surgery, Kori Hospital, Kansai Medical University, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okazaki
authors.affiliation: Department of General and Gastroenterological Surgery, Fujigaoka Hospital, Showa University, Yokohama, Japan.
authors.forename: Sumito
authors.initials: S
authors.lastname: Sato
authors.affiliation: Cancer Center, Aizawa Hospital, Matsumoto, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.
authors.forename: Homin
authors.initials: H
authors.lastname: Kim
authors.affiliation: Translational Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.affiliation: Tokaki Central Hospital, Kamigahara City, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Oncology Center, Aichi Medical University Hospital, Aichi, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mishima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000068258:Bevacizumab / Q000008:administration & dosage; D000069287:Capecitabine / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068258:Bevacizumab; D000069287:Capecitabine
keywords: Chemotherapy; XELOX; bevacizumab; bi-weekly; phase II study