title: Multicenter phase II study of FOLFIRI plus bevacizumab after discontinuation of oxaliplatin-based regimen for advanced or recurrent colorectal cancer (CR0802).
abstract: BACKGROUND
  To investigate the efficacy and safety of FOLFIRI plus bevacizumab regimen with irinotecan (180 mg/m(2)) in patients with advanced or recurrent colorectal cancer who were of the wild-type or heterozygous group for UGT1A1*28 and *6 polymorphisms and discontinued to oxaliplatin-based regimen, prospectively.
  
  
  METHODS
  The study population consisted of patients who had discontinued oxaliplatin-based regimen for any reason. The primary endpoint was the response rate. FOLFIRI and bevacizumab regimen [irinotecan: 180 mg/m(2), 5-fluorouracil infusion: 2400 mg/m(2), 5-fluorouracil bolus: 400 mg/m(2), levofolinate calcium: 200 mg/m(2), bevacizumab: 5 mg/kg] was repeated every 2 weeks for up to 24 cycles.
  
  
  RESULTS
  Ninety-four patients were enrolled; 93 patients were evaluated on safety, 94 patients on efficacy. The response rate was 10.1% (95% confidence interval (CI): 4.7-18.3%). The median time to treatment failure, progression-free survival, and overall survival were 4.1 months (95% CI: 2.8-4.8 months), 5.4 months (95% CI: 4.1-6.2 months), and 14.5 months (95% CI: 11.8-17.0 months), respectively. The treatment-related death was 1.1%, and the early death ≤30 days after the last study treatment was 1.1%. The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue. All these adverse events and other adverse events were controllable.
  
  
  CONCLUSIONS
  FOLFIRI plus bevacizumab regimen with an initial irinotecan dose of 180 mg/m(2) exhibited an adequate antitumor effect and was confirmed to be manageable and tolerable in Japanese patients with advanced or recurrent colorectal cancer, who had discontinued oxaliplatin-based regimen.
  
  
  BACKGROUND
  UMIN000001817 .
authors.affiliation: Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. m.suenaga@jfcr.or.jp.
authors.forename: Mitsukuni
authors.initials: M
authors.lastname: Suenaga
authors.affiliation: National Hospital Organization Shikoku Cancer Center, Kou 160 Minamiumemotomachi, Matsuyama, Ehime, 791-0280, Japan. tnishina@shikoku-cc.go.jp.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishina
authors.affiliation: Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. mizunuma@jfcr.or.jp.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Mizunuma
authors.affiliation: National Hospital Organization Kyoto Medical Center, 1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto-shi, Kyoto, 612-8555, Japan. yasui-kyt@umin.ac.jp.
authors.forename: Hisateru
authors.initials: H
authors.lastname: Yasui
authors.affiliation: Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. tura@aichi-cc.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.affiliation: Chiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba, 260-0801, Japan. tdenda@chiba-cc.jp.
authors.forename: Tadamichi
authors.initials: T
authors.lastname: Denda
authors.affiliation: Japanese Red Cross Kitami Hospital, North-6, East-2, Kitami, Hokkaido, 090-0026, Japan. j_ikeda@kitami.jrc.or.jp.
authors.forename: Junichi
authors.initials: J
authors.lastname: Ikeda
authors.affiliation: National Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka, 811-1395, Japan. tesaki@nk-cc.go.jp.
authors.forename: Taito
authors.initials: T
authors.lastname: Esaki
authors.affiliation: Hyogo Cancer Center, 13-70, Kitaouji-chou, Akashi, Hyogo, 672-8558, Japan. honssk-d@sanynet.ne.jp.
authors.forename: Hogara
authors.initials: H
authors.lastname: Nishisaki
authors.affiliation: Southern Tohoku General Hospital, 7-115, Yatsuyamada, Koriyama, Fukushima, 963-8563, Japan. ytakano36@gmail.com.
authors.forename: Yoshinao
authors.initials: Y
authors.lastname: Takano
authors.affiliation: Teikyo University School of Medicine University Hospital, Mizonokuchi, 3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan. ysugi@gmhosp.gifu.gifu.jp.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. kmuro@aichi-cc.jp.
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000068258:Bevacizumab / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin