Cancer Research and Treatment

Original Articles

Gastrointestinal cancer

A Phase II Study of Preoperative Chemoradiotherapy with Capecitabine Plus Simvastatin in Patients with Locally Advanced Rectal Cancer: Hyunji Jo, 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; Cancer Res Treat. 2023;55(1):189-195. Published online June 8, 2022; DOI: https://doi.org/10.4143/crt.2021.1527

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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Short- and long-term outcomes of neoadjuvant chemotherapy compared with neoadjuvant chemoradiotherapy for locally advanced rectal cancer: an updated meta-analysis
Yue Guo, Zhifeng Guo, Jiaojiao Zhang, Guowu Qian, Wangquan Ji, Linlin Song, Zhe Guo, Zhuo Han
BMC Gastroenterology.2025;[Epub] CrossRef
A randomized phase II/III trial of rosuvastatin with neoadjuvant chemo-radiation in patients with locally advanced rectal cancer
Prachi S. Patil, Avanish Saklani, Naveena A. N. Kumar, Ashwin De’Souza, Rahul Krishnatry, Snehal Khanvilkar, Mufaddal Kazi, Reena Engineer, Vikas Ostwal, Anant Ramaswamy, Munita Bal, Priya Ranganathan, Ekta Gupta, Sanjeev Galande
Frontiers in Oncology.2025;[Epub] CrossRef
Effects of Hyperlipidemia on Osseointegration of Dental Implants and Its Strategies
Haiyang Sun, Shuhuai Meng, Junyu Chen, Qianbing Wan
Journal of Functional Biomaterials.2023; 14(4): 194. CrossRef

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Clinical Outcomes of Local Excision Following Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer: Nam Kwon Lee, Dae Yong Kim, Sun Young Kim, Jae Hwan Oh, Won Park, Doo Ho Choi, Taek-Keun Nam, Kyung-Ja Lee; Cancer Res Treat. 2014;46(2):158-164. Published online April 15, 2014; DOI: https://doi.org/10.4143/crt.2014.46.2.158

Abstract PDF PubReader ePub

Purpose

To evaluate the treatment outcomes of local excision following preoperative chemoradiotherapy in patients with locally advanced rectal cancer who have not undergone radical surgery for any reason.

Materials and Methods

The data of 27 patients with locally advanced rectal cancer who underwent preoperative chemoradiotherapy followed by local excision were analyzed retrospectively. The primary endpoint was the 5-year relapse-free survival rate, and the secondary endpoint was the pattern of recurrence.

Results

The median follow-up time was 81.8 months (range, 28.6 to 138.5 months). The 5-year local relapse-free survival (LRFS), distant metastasis-free survival (DMFS), relapse-free survival (RFS), and overall survival (OS) were 88.9%, 81.1%, 77.8%, and 85.0%, respectively. Six (22%) patients developed treatment failure; one (4%) patient had local recurrence only, three (11%) patients had distant recurrence only, and two (7%) patients had both. The 5-year LRFS, DMFS, RFS, and OS for patients with ypT0-1 compared with ypT2-3 were 94.1% vs. 77.8% (p=0.244), 94.1% vs. 55.6% (p=0.016), 88.2% vs. 55.6% (p=0.051), and 94.1% vs. 66.7% (p=0.073), respectively.

Conclusion

Local excision following preoperative chemoradiotherapy may be an alternative treatment for highly selected patients with locally advanced rectal cancer who have achieved ypT0-1 after preoperative chemoradiotherapy.

Citations

Citations to this article as recorded by

Organ‐saving surgery for rectal cancer after neoadjuvant chemoradiation: Analysis of failures and long‐term results
Maurizio Cosimelli, Pietro Ursi, Raffaello Mancini, Giada Pattaro, Pasquale Perri, Chiara Parrino, Valerio De Peppo, Maria Grazia Diodoro, Andrea Balla, Gian Luca Grazi
Journal of Surgical Oncology.2020; 121(2): 375. CrossRef
Local excision for ypT2 rectal cancer following preoperative chemoradiation therapy: it should not be justified
Kwan Mo Yang, Seok-Byung Lim, Jong Lyul Lee, Chan Wook Kim, Yong Sik Yoon, In Ja Park, Chang Sik Yu, Jin Cheon Kim
International Journal of Colorectal Disease.2018; 33(4): 487. CrossRef
Are We Predicting Disease Progress of the Rectal Cancer Patients without Surgery after Neoadjuvant Chemoradiotherapy?
Bo Young Oh, Jung Wook Huh, Woo Yong Lee, Yoon Ah Park, Yong Beom Cho, Seong Hyeon Yun, Hee Cheol Kim, Ho-Kyung Chun
Cancer Research and Treatment.2018; 50(3): 634. CrossRef
Total Mesorectal Excision Versus Local Excision After Favorable Response to Preoperative Chemoradiotherapy in “Early” Clinical T3 Rectal Cancer: A Propensity Score Analysis
Young Seob Shin, Chang Sik Yu, Jin-hong Park, Jin Cheon Kim, Seok-Byung Lim, In Ja Park, Tae Won Kim, Yong Sang Hong, Kyu-pyo Kim, Sang Min Yoon, Ji Hyeon Joo, Jong Hoon Kim
International Journal of Radiation Oncology*Biology*Physics.2017; 99(1): 136. CrossRef
Controversial issues in radiotherapy for rectal cancer: a systematic review
Jong Hoon Kim
Radiation Oncology Journal.2017; 35(4): 295. CrossRef
Local excision of low rectal cancer treated by chemoradiotherapy: is it safe for all patients with suspicion of complete tumor response?
Clotilde Debove, Nathalie Guedj, Ecoline Tribillon, Léon Maggiori, Magaly Zappa, Yves Panis
International Journal of Colorectal Disease.2016; 31(4): 853. CrossRef
Seven low-mass ions in pretreatment serum as potential predictive markers of the chemoradiotherapy response of rectal cancer
Kangsan Roh, Seung-Gu Yeo, Byong Chul Yoo, Kyung-Hee Kim, Sun Young Kim, Min-Jeong Kim
Anti-Cancer Drugs.2016; 27(8): 787. CrossRef
A Systematic Review of Local Excision After Neoadjuvant Therapy for Rectal Cancer: Are ypT0 Tumors the Limit?
Sally Hallam, David E. Messenger, Michael G. Thomas
Diseases of the Colon & Rectum.2016; 59(10): 984. CrossRef
Definitive high-dose radiotherapy with concurrent chemotherapy for locally advanced rectal cancer
Min-Jeong Kim, Eun Seok Kim, Seung-Gu Yeo
Medicine.2016; 95(40): e5059. CrossRef
Association of pretreatment serum carcinoembryonic antigen levels with chemoradiation-induced downstaging and downsizing of rectal cancer
SEUNG-GU YEO
Molecular and Clinical Oncology.2016; 4(4): 631. CrossRef
The Role of Fibrinogen as a Predictor in Preoperative Chemoradiation for Rectal Cancer
Jong Hoon Lee, Jong Hee Hyun, Dae Yong Kim, Byong Chul Yoo, Ji Won Park, Sun Young Kim, Hee Jin Chang, Byung Chang Kim, Tae Hyun Kim, Jae Hwan Oh, Dae Kyung Sohn
Annals of Surgical Oncology.2015; 22(1): 209. CrossRef
Oncologic Outcomes according to the Treatment Strategy in Radiologic Complete Responders after Neoadjuvant Chemoradiation for Rectal Cancer
Soo Young Lee, Chang Hyun Kim, Young Jin Kim, Hyeong Rok Kim
Oncology.2015; 89(6): 311. CrossRef

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Effects of Concurrent Chemoradiotherapy Followed by Surgery in Locoreginal Cancer - preliminary report -: Yun Hae Chang, Sung Bae Kim, Sang Hee Kim, Jong SU Choi, Dae Young Chang, Je Whan Lee, Sang We Kim, Cheolwon Suh, Kyon Hung Lee, Jung Shin Lee, Woo Gyun Kim, Ho Young Song, Hye Sook Chang, Hong Hoon K; J Korean Cancer Assoc. 1996;28(4):690-698.

Abstract PDF: Prognosis of locoregional esophageal cancer treated with conventional surgery or radiotherapy alone has been very poor. In order to improve outcome and determine the efficacy of a combined modality therapy, this prospective study was performed. Between May 1993 and April l995, 44 patients with locoregional esophageal cancer were entered this study. They were treated with 2 courses of 5-FU(DI-5, D30-33) and cisplatin (Dl, D29) plus 48Gy radiation therapy over 4 weeks. 44 patients completed the preoperative reatment. A transhiatal esophagectomy was planned 3~4 weeks after chemoradiotherapy. Clinical response were reevaluable in 43 patients after treatment: 34 patients showed improvement, 5 patients showed stable, 4 patients showed progression. One patient was died of sepsis 1 week after completion of chemotherapy. l8 patients underwent operation after chemoradiation and 9 patients showed complete pathologic response. Grade 3,4 leukopenia and thrombocytopenia were observed in 21% and 7%, respectively. Esophagitis and vomiting were moderate to severe in 43% patients. Median follow-up duration was 7.5months(2-21M), the median survival was not reached. In conclusion, this intensive combined therapy is promising modality with regards to relatively high pathologic complete response rate. Further randomized Jarge scaled study was warrented

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