Adjuvant modified FOLFOX-4 in patients with stage III rectum adenocarcinoma

The aim of this study was to investigate efficacy and toxicity of a modified 5-fluorouracil (5-FU), folinic acid, oxaliplatin (mFOLFOX-4) regimen followed by infusional 5-FU concomitant with radiotherapy for curatively resected stage III rectum adenocarcinoma patients.

Between April 2005 and July 2009, 55 operated stage III rectum cancer patients were evaluated retrospectively. mFOLFOX-4 regimen (oxaliplatin 85 mg/m2 1st day, folinic acid 200 mg/m2 1st day, 5-FU 400 mg/m2 iv bolus 1st day, 5-FU 1600 mg/m2 46 hours continuous infusion) was applied every 2 weeks. After four courses of mFOLFOX-4, 50.4 Gy (1.8 Gy in 28 fractions) radiotherapy with continuous 5-FU 200 mg/m(2)/day by infusion pump were given. On completion of chemoradiation four more mFOLFOX-4 courses were given.

Median age of the patients was 54 years (range 23-73 years). Low anterior resection was performed in 37 (67.3%) and abdominoperineal resection in 16 (29.1%) . Ten (18.2%) patients were at stage IIIA, 24 (43.6%) at stage IIIB and 21 (38.2%) at stage IIIC. Planned chemotherapy cycles were completed in 92.7% of patients. Grades 3-4 toxicity included neutropenia (9.1%), febrile neutropenia (3.6%), anemia (3.6%), diarrhea (21.8%), neuropathy (9.1%), renal toxicity (3.6%), hepatotoxicity (5.5%). Median follow-up time was 30 (9-57) months. Local recurrence and distant metastasis was observed in 3 (5.5%) and 10 (18.2%) patients, respectively. Ten (18.2%) patients died during follow-up. Three years disease free survival and overall survival were 67.5% and 77.3%, respectively.

mFOLFOX-4 following chemoradiotherapy with continuous 5- FU infusion is an effective and well tolerated adjuvant treatment for stage III rectal carcinoma patients.