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학술저널
저자정보
조현지 (성균관대학교) 김승태 (삼성서울병원) 이지연 (성균관대학교) 박세훈 (성균관대학교) 박준오 (성균관대학교) 박영석 (성균관대학교) 임호영 (삼성서울병원) 유정일 (삼성서울병원) 박희철 (삼성서울병원) 최두호 (삼성서울병원) 박윤아 (삼성서울병원) 조용범 (삼성서울병원) 허정욱 (삼성서울병원) 윤성현 (삼성서울병원) 김희철 (삼성서울병원) 이우용 (삼성서울병원) 강원기 (성균관대학교)
저널정보
대한암학회 Cancer Research and Treatment Cancer Research and Treatment 제55권 제1호
발행연도
2023.1
수록면
189 - 195 (7page)
DOI
10.4143/crt.2021.1527

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Purpose The purpose of this phase II trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, to preoperative chemoradiotherapy (CRT) with capecitabine confers a clinical benefit to patients with locally advanced rectal cancer (LARC).Materials and Methods Patients with LARC (defined by clinical stage T3/4 and/or lymph node positivity) received preoperative radiation (45-50.4 Gy in 25-28 daily fractions) with concomitant capecitabine (825 mg/m2 twice per day) and simvastatin (80 mg, daily). Curative surgery was planned 4-8 weeks after completion of the CRT regimen. The primary endpoint was pathologic complete response (pCR). The secondary endpoints included sphincter-sparing surgery, R0 resection, disease-free survival, overall survival, the pattern of failure, and toxicity.Results Between October 2014 and July 2017, 61 patients were enrolled; 53 patients completed CRT regimen and underwent total mesorectal excision. The pCR rate was 18.9% (n=10) by per-protocol analysis. Sphincter-sparing surgery was performed in 51 patients (96.2%). R0 resection was achieved in 51 patients (96.2%). One patient experienced grade 3 liver enzyme elevation. No patient experienced additional toxicity caused by simvastatin.Conclusion The combination of 80 mg simvastatin with CRT and capecitabine did not improve pCR in patients with LARC, although it did not increase toxicity.

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