Low-dose versus Standard-Dose Leucovorin in the Treatment of Colon Cancer: Mansoura University Clinical Experience in Facing the Problem of Leucovorin Shortage

Abstract

Background: Drug shortages have become a health care problem worldwide. One of the important drugs that are affected by shortage is leucovorin. It is used with 5-fluorouracil in many protocols for gastro-intestinal tumors and its shortage would have a negative impact on the treatment outcome. Aim: To compare the effect of low-dose leucovorin versus the standard-dose in the treatment of stage II and III colon cancer. Methods: The study included 100 patients with stage II or III adenocarcinoma of the colon who presented to the Clinical Oncology Department at Mansoura University Hospital from January 2011 till December 2012 after curative resection and were scheduled to receive adjuvant FOLFOX6 regimen. Patients were randomly allocated to receive standard-dose leucovorin (200 mg/m2, group 1) or low-dose leucovorin (125 mg/m2, group 2), both administered on days 1 and 2 over 2 hours infusion before 5-fluoruracil. The end points were toxicity, disease free survival (DFS) and overall survival (OS). Results: The two study groups were matched regarding age, sex, and tumor stage. The mean DFS was 48.36 months for group 1 and 49.12 for group 2 with no significant difference (p=0.866). The mean OS was 65.07 months for group 1 and 62.45 for group 2 with no significant difference (p=0.544). Similarly, there was no significant difference between the two groups regarding hematosuppression, diarrhea, mucositis, neurotoxicity and the need for hospitalization. Conclusion: Both protocols were well tolerated by all patients with no significant difference in the treatment outcome. The use of low-dose leucovorin protocol can help in solving the leucovorin shortage problem.