Phase II study of FOLFOX4 with "wait and go" strategy as first-line treatment for metastatic colorectal cancer.

Purpose: To evaluate the efficacy and safety of FOLFOX4 using "wait and go" strategy in treating metastatic colorectal cancer.

Methods: 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).

Results: 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.

Conclusions: These findings indicate that this "wait and go" strategy reduces the frequency of persistent neuropathy while maintaining efficacy against metastatic colorectal cancer.