A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal CancerReport as inadecuate




A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal Cancer - Download this document for free, or read online. Document in PDF available to download.

Background: Preoperative chemoradiotherapy CRT with 5-FU has been widely used to improve local control of disease and to preserve anal sphincter in the treatment of rectal cancer. UFT and S-1 as oral dihydropyrimidine dehydrogenase DPD-inhibitory fluoropyrimidines enhance the therapeutic effect of 5-FU by modulating its metabolic pathways. The purpose of this study was to evaluate the efficacy and toxicity of CRT using UFT versus S-1 in patients with locally advanced rectal cancer. Methods: Fifty-nine patients who received preoperative CRT 40 Gy radiotherapy were randomly assigned to either UFT or S-1 groups. UFT and S-1 were administered during the radiotherapy course. Response to CRT was determined using a histopathologic examination and RECIST of surgically resected specimens and classified as responders CR, PR and grade 2, 3 or nonresponders SD, PD and grade 0, 1. Results: All patients were randomly allocated to S-1 group n = 30 or UFT group n = 29. Pathological response rate Grade2 and Grade3 was 57% in the S-1 group and 45% in the UFT group p = 0.36. Pathological complete response CR rate Grade3 was 7% in the S-1 group and 4% in the UFT group p = 0.98. There was no statistically significant difference between the two groups in regard to the response rate of RECIST p = 0.52. There was no statistically significant difference between the groups based on the downstaging rate, resection of tumor, sphincter preservation and marginal invasion. The incidence of Grade 3 diarrhea was significantly more frequent in the S-1 group 7% compared with the UFT group 0% p = 0.02. Conclusion: The results supported the conclusion that CRT using UFT or S-1 is effective and feasible for patients with locally advanced rectal cancer.

KEYWORDS

S-1; UFT; Chemoradiation; Rectal Cancer

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M. Hotchi, H. Okitsu, M. Miura, M. Hamada, Y. Sonaka, Y. Fukuda, T. Ando and S. Kuratate -A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal Cancer,- Journal of Cancer Therapy, Vol. 3 No. 6A, 2012, pp. 989-995. doi: 10.4236-jct.2012.326127.





Author: Masanori Hotchi, Hiroshi Okitsu, Murato Miura, Madoka Hamada, Yasuhide Sonaka, Yoh Fukuda, Tsutomu Ando, Shinji Kuratate

Source: http://www.scirp.org/



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