Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701)

• Published in: Oncology Vol. 84; no. 4; p. 233
• Main Authors: Oki, Eiji, Emi, Yasunori, Akagi, Yoshito, Tokunaga, Shoji, Sadanaga, Noriaki, Tanaka, Takaho, Ogata, Yutaka, Saeki, Hiroshi, Kakeji, Yoshihiro, Baba, Hideo, Nishimaki, Tadashi, Natsugoe, Shoji, Shirouzu, Kazuo, Maehara, Yoshihiko
• Format: Journal Article
• Language: English
• Published: Switzerland 01-01-2013
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - mortality; Colorectal Neoplasms - pathology; Colorectal Neoplasms - surgery; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Humans; In Vitro Techniques; Leucovorin - adverse effects; Leucovorin - therapeutic use; Middle Aged; Nausea - chemically induced; Neutropenia - chemically induced; Organoplatinum Compounds - adverse effects; Organoplatinum Compounds - therapeutic use; Treatment Outcome; Vomiting - chemically induced
• DOI: 10.1159/000346690
• EISSN: 1423-0232

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.
Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI.
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%).
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.