Metronomic Low Dose Leucovorin- Fluorouracil versus Supportive Treatment for Patients with Recurrent or Metastatic Colorectal Cancer

Abstract

Introduction: There was an improvement in therapeutic regimens for advanced colorectal cancer (CRC) in the last few decades. The low dose metronomic palliative chemotherapy in patients with advanced CRC after the failure of standard chemotherapy led to a dramatic increase in efficacy, reduction of mortality rates, and improves survival in the form of control symptoms, and enhances or improves quality of life which is an important issue in that group of patients. Patients and Methods: We include 60 Patients with recurrent or metastatic colorectal cancer after failure of multiple lines of chemotherapy. The patients were randomized in two groups either to receive supportive treatment in group A (30 patients) or low dose weekly leucovorin 20 mg/m² plus 5-flourouracil 425 mg/m² for 3 weeks and 1 week rest in group B (30 patients). Patients in group B received palliative chemotherapy for 4 months at least. Results: After a follow up period of 19 months, the mean time to progression (TTP) is 4.9 months for the group (A) but is higher in group (B) as it is 7.8 months and it shows a statistically significant difference (P value <0.001). Also, the mean overall survival(OS) is 15.3 months for group (A) and 18.8 months for group (B) and this is statistically significant (P value <0.002). No grade 3 or 4 toxicity was detected. After 4 months of the study, 29 patients (96.6%) still have the stable disease compared to 18 patients (60%) of group (A). After 8 months, only 12 patients (40%) of group (B) show stable disease while all patients of group (A) have disease progression. Conclusion: We conclude that metronomic weekly leucovorin-5 FU could provide a good tolerable way to go on with chemotherapy treatment while at the same time not have major threatening side effects.