A comparative study of neoadjuvant chronomodulated folfox and radiotherapy vs. Conventional folfox and radiotherapy in locally advanced carcinoma rectum

Abstract

Aim: This study was undertaken to determine and compare the efficacy and toxicity of chronomodulated FOLFOX + radiotherapy to conventional FOLFOX + radiotherapy in the neoadjuvant setting of locally advanced rectal cancer. Materials and methods: A total of 44 patients were randomly assigned to the two arms with 24 in chronomodulated arm (Arm A) and 20 in conventional arm (Arm B).Four cycles of FOLFOX chemotherapy followed by radiotherapy were given to18 patients in Arm A and all the 20 patients in Arm B completed the treatment. All the patients were evaluated for surgery. Tumor down staging and toxicity profile were compared. Results: tumor down staging and sphincter preservation rates were similar in both the arms. Incidence of grade-III and grade-IV stomatitis, diarrhea and paresthesia was more in Arm B than in Arm A. Nausea was the most common symptom in both the treatment arms.83% patients in Arm A and 86% patients in Arm B experienced nausea at some point during the treatment. Diarrhea was more common in Arm B with 15 % patients experiencing grade 3-4 diarrhea when compared to 5.55% in Arm A. Stomatitis was more common in Arm B with 10% patients experiencing grade 3-4 toxicity as compared to 5.5% in Arm A. It was observed with increased frequency in Arm B with 7(20%) patients experiencing grade 3 sensory neuropathy compared to 2(11.1%) in Arm A. The incidence of hematological toxicities was similar in both arms with only grade 1 and 2 neutropenia occurring in both the arms. The incidence of leucopenia was greater in the conventional arm (Arm B).Conclusions: we conclude that the administration of Chronomodulated FOLFOX followed by radiotherapy has a better toxicity profile and hence better tolerance and similar tumor down staging when compared to conventional FOLFOX and radiotherapy in the neoadjuvant treatment of locally advanced carcinoma rectum.