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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2021.1527    [Accepted]
A Phase II Study of Preoperative Chemoradiotherapy with Capecitabine Plus Simvastatin in Patients with Locally Advanced Rectal Cancer
Hyunji Jo1 , Seung Tae Kim1, Jeeyun Lee1, Se Hoon Park1, Joon Oh Park1, Young Suk Park1, Ho Yeong Lim1, Jeong Il Yu2, Hee Chul Park2, Doo Ho Choi2, Yoonah Park3, Yong Beom Cho3, Jung Wook Huh3, Seong Hyeon Yun3, Hee Cheol Kim3, Woo Yong Lee3, Won Ki Kang1
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence  Won Ki Kang ,Tel: 82-2-3410-3451, Fax: 82-2-3410-1754, Email: wkkang@skku.edu
Received: November 23, 2021;  Accepted: June 7, 2022.  Published online: June 8, 2022.
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.
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.
The combination of 80 mg simvastatin with CRT and capecitabine did not improve pCR in patients with LARC, although it did not increase toxicity.
Key words: Rectal neoplasms, Simvastatin, Capecitabine, Preoperative chemoradiotherapy, Pathologic complete response
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