Cancer Research and Treatment

Original Article

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.

Citations

Citations to this article as recorded by

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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Case Report

Osimertinib Combined with Systemic Chemotherapy for EGFR Mutant, T790M-Negative, Non–Small Cell Lung Cancer Patients Who Develop Leptomeningeal Metastases with Extracranial Progression to Prior EGFR TKI: Hye Ryeon Kim, Hyunji Jo, Hongsik Kim, Joohyun Hong, Sehhoon Park, Hyun Ae Jung, Se-Hoon Lee, Jin-Seok Ahn, Myung-Ju Ahn; Cancer Res Treat. 2023;55(1):344-349. Published online March 26, 2022; DOI: https://doi.org/10.4143/crt.2021.1603

Abstract PDF PubReader ePub

Leptomeningeal metastasis (LM) is a rare but fatal clinical condition with a short survival time. The incidence of LM from epidermal growth factor receptor mutant (EGFRm) non–small cell lung cancer (NSCLC) has increased due to the limited efficacy of first- or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in the central nervous system (CNS). Osimertinib is a third-generation, irreversible, CNS penetrant, oral EGFR TKI that demonstrates promising efficacy in CNS metastases regardless of T790M. Herein, we report four cases of T790M-negative EGFRm NSCLC patients treated with osimertinib combined with systemic chemotherapy, who progressed on prior EGFR TKI and developed LM with extracranial lesions. The combination treatment was well tolerated, and the mean overall survival from LM diagnosis was 14.7 months (95% confidence interval, 10.4 to 19.0). These results suggest that osimertinib combined with systemic chemotherapy would be a reasonable treatment option for T790M-negative EGFRm NSCLC patients who develop LM with extracranial progression to prior EGFR TKI. A further prospective study is warranted.

Citations

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Yi Yue, Yuqing Ren, Chunya Lu, Nan Jiang, Sihui Wang, Junkai Fu, Mengrui Kong, Guojun Zhang
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Expert Review of Neurotherapeutics.2024; 24(1): 77. CrossRef
Osimertinib is associated with improved outcomes in pre-treated non-small cell lung cancer leptomeningeal metastases: A systematic review and meta-analysis
David J.H. Bian, Anna-Maria Lazaratos, Sarah M. Maritan, Andrea Quaiattini, Zhimin Zeng, Zhengfei Zhu, Ugur Sener, Rachna Malani, Yu Jung Kim, Eiki Ichihara, Victor Cohen, April A.N. Rose, Nathaniel Bouganim, Matthew Dankner
Heliyon.2024; 10(9): e29668. CrossRef
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Reactions Weekly.2023; 1943(1): 90. CrossRef

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