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

Cancer Chemother Pharmacol. 2011 Nov;68(5):1215-22. doi: 10.1007/s00280-011-1605-0. Epub 2011 Mar 17.

Abstract

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.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Leucovorin / administration & dosage
  • Male
  • Middle Aged
  • Neoplasm Metastasis*
  • Organoplatinum Compounds / administration & dosage

Substances

  • Organoplatinum Compounds
  • Leucovorin
  • Fluorouracil

Supplementary concepts

  • Folfox protocol