Neoadjuvant treatment of mid-to-lower rectal cancer with oxaliplatin plus 5-fluorouracil and leucovorin in combination with radiotherapy: a Korean single center phase II study.

International Journal of Clinical Oncology
Won-Suk LeeDong Hae Jung

Abstract

To evaluate the safety and efficacy of neoadjuvant chemoradiation with oxaliplatin and 5-fluorouracil (5-FU) in advanced mid-to-lower rectal cancer. This was a single-arm, open-label phase II study conducted between August 2008 and August 2010. Thirty-one patients (n = 31) with clinical stage T3/T4 or lymph node positive rectal adenocarcinoma located in the middle or lower rectum without metastasis were enrolled onto the study. Data were analyzed according to the intention-to-treat principle. Thirty-one patients were enrolled into the study. Six patients (19.4%) experienced grade 3 diarrhea. Grade 2 nausea and vomiting occurred in 5 and 2 patients, respectively. Severe neurotoxicity was not observed. Grade 1 sensory neuropathy occurred in 10 patients (32.3%). Sphincter-saving surgery was performed in 29 patients (93.5%). The mean distance of the tumor from the anal verge was 4.9 cm. Anastomotic leakage occurred in 4 of 29 (13.8%) patients. The circumferential resection margin was involved in 2 patients (6.5%). Overall, 23 patients (77.4%) responded to treatment. The complete pathologic response (ypCR) rate was 12.9%. There was no death secondary to toxicity, and the mean follow-up time was 12.3 months. The overall toxicity of o...Continue Reading

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