title: Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701).
abstract: OBJECTIVE
  This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer.
  
  
  METHODS
  Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI.
  
  
  RESULTS
  The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7% [95% confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months (95% CI 7.5-11.9), and the median overall survival was 28.4 months (95% CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26%), neutropenia (55%), anemia (4%), neurotoxicity (0%), diarrhea (2%), febrile neutropenia (4%), nausea (4%), vomiting (2%), and hypersensitivity (0%).
  
  
  CONCLUSIONS
  The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.
authors: Department of Surgery, Kurume University School of Medicine, Kurume, Japan. okieiji@surg2.med.kyushu-u.ac.jp
authors: Eiji
authors: E
authors: Oki
authors: Yasunori
authors: Y
authors: Emi
authors: Yoshito
authors: Y
authors: Akagi
authors: Shoji
authors: S
authors: Tokunaga
authors: Noriaki
authors: N
authors: Sadanaga
authors: Takaho
authors: T
authors: Tanaka
authors: Yutaka
authors: Y
authors: Ogata
authors: Hiroshi
authors: H
authors: Saeki
authors: Yoshihiro
authors: Y
authors: Kakeji
authors: Hideo
authors: H
authors: Baba
authors: Tadashi
authors: T
authors: Nishimaki
authors: Shoji
authors: S
authors: Natsugoe
authors: Kazuo
authors: K
authors: Shirouzu
authors: Yoshihiko
authors: Y
authors: Maehara
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D066298:In Vitro Techniques; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin