Phase II study of FOLFOX4 with “wait and go” strategy as first-line treatment for metastatic colorectal cancer
To evaluate the efficacy and safety of FOLFOX4 using “wait and go” strategy in treating metastatic colorectal cancer.
The conventional FOLFOX4 was repeated every 2 weeks. We waited until the recovery of symptoms from persistent neurotoxicity within an added period of 2 weeks, before performing the next cycle (“wait and go” strategy).
We enrolled 58 patients, in whom a total of 481 cycles were administered (median 8 per patient; range 1–16). Toxicity was evaluated in 58 patients and response in 55. The major toxic effect was grade 3/4 neutropenia (33%). Painful paresthesia or persistent functional impairment was observed in 4 patients (7%). The response rate was 40% (95% confidence interval; 27.1–52.9%). The median progression-free survival time was 10.2 months, the 1-year survival rate was 89%, and the median overall survival time was 27.6 months.
These findings indicate that this “wait and go” strategy reduces the frequency of persistent neuropathy while maintaining efficacy against metastatic colorectal cancer.
KeywordsFOLFOX Neuropathy Metastatic colorectal cancer Oxaliplatin “Wait and go”
We are grateful to W. Koizumi, Y. Shimada, and S. Maetani for their kind advice and to M. Kurihara, H. Takahashi, and A. Kawano who constituted out the independent review committee. We also thank S. Koyama and Y. Kakehashi for their data managements. This study has been presented in part at the 7th Annual Meeting of the Japanese Society of Medical Oncology, Aichi, Japan, 2009. This study was supported by the Japan Clinical Cancer Research Organization (JACCRO). The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript.
Conflict of interest
No authors have any conflict of interest.
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