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Phase II Trial of Alternating mFOLFOX6 and FOLFIRI Regimens in the First-Line Treatment for Unresectable or Metastatic Colorectal Cancer (KSCC0701)Oki E.b · Emi Y.b · Akagi Y.a · Tokunaga S.c · Sadanaga N.d · Tanaka T.e · Ogata Y.a · Saeki H.b · Kakeji Y.f · Baba H.g · Nishimaki T.h · Natsugoe S.i · Shirouzu K.a · Maehara Y.b · Kyushu Study Group of Clinical Cancer
aDepartment of Surgery, Kurume University School of Medicine, Kurume, bDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, cMedical Information Center, Kyushu University Hospital, dDepartment of Surgery, Saiseikai Fukuoka General Hospital, and eDepartment of Surgery, Social Insurance Tagawa Hospital, Fukuoka, fDivision of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, gDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, hDivision of Digestive and General Surgery, University of the Ryukyus Faculty of Medicine, Okinawa, and iDepartment of Surgical Oncology and Digestive Surgery, Kagoshima University, Kagoshima, Japan
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. Patients and 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.
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