Therapeutic use and profile of toxicity of the FOLFOX4 regimen

Abstract Introduction Since the publication of the MOSAIC test results in 2004, the FOLFOX4 regimen has been established as an adjuvant treatment which is recommended in stage III colorectal cancer. The aim of this study is to assess the use of this regimen in our field and to describe its toxicity. Methods Descriptive study of treatments with FOLFOX4 prescribed between April 2005 and March 2007. The data was obtained from the Farhos Oncologia® programme and clinical records. The following data was collected: age, gender, diagnosis, stage of the illness (TNM classification), and adverse reactions, expressing severity according to Common Toxicity Criteria 2.0. Results The FOLFOX4 regimen was prescribed for 39 patients (24 men and 15 women) with an average age of 59. The diagnoses were: 28 colon cancer (4 stage II, 17 stage III, and 7 stage IV), 10 rectal cancer (1 stage II, 4 stage III, and 5 stage IV), and 1 stage IV gastric cancer. The most frequent adverse reactions were peripheral neuropathy (82%), neutropaenia (56.4%), and diarrhoea (53.9%). When the study was completed, 9 patients continued active treatment with the regimen (average, 6.8 cycles). Of the 30 remaining patients only 16 people completed the 12 planned cycles. Forteen patients stopped their treatment (average, 8.1 cycles) due to toxicity in 10 cases, clinical progression in 3 cases, and 1 patient died. Of the total 368 cycles administered, 68 suffered administration delays and 22 had the dosage reduced. Conclusion The use of the FOLFOX4 regimen has been adjusted to uses with some solid scientific evidence, but its toxicity has limited its use and has made administering the planned dosage levels difficult.