A Phase II Study of Preoperative Chemoradiotherapy with Capecitabine Plus Simvastatin in Patients with Locally Advanced Rectal Cancer
- Author:
Hyunji JO
1
;
Seung Tae KIM
;
Jeeyun LEE
;
Se Hoon PARK
;
Joon Oh PARK
;
Young Suk PARK
;
Ho Yeong LIM
;
Jeong Il YU
;
Hee Chul PARK
;
Doo Ho CHOI
;
Yoonah PARK
;
Yong Beom CHO
;
Jung Wook HUH
;
Seong Hyeon YUN
;
Hee Cheol KIM
;
Woo Yong LEE
;
Won Ki KANG
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2023;55(1):189-195
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
