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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2023.283    [Accepted]
A randomized Phase II Study of Irinotecan Plus Cisplatin with or without Simvastatin in ever Smokers with Extended Disease Small Cell Lung Cancer
Youngjoo Lee1 , Soo-Hyun Lee2, Geon Kook Lee3, Eun Jin Lim1, Ji-Youn Han1
1Center for Lung Cancer, National Cancer Center, Goyang, Korea
2Department of Radiology, National Cancer Center, Goyang, Korea
3Department of Pathology, National Cancer Center, Goyang, Korea
Correspondence  Ji-Youn Han ,Tel: 82-31-920-1154, Email: jymama@ncc.re.kr
Received: January 9, 2023;  Accepted: March 16, 2023.  Published online: March 20, 2023.
This study evaluated whether an addition of simvastatin to chemotherapy improves survival in ever-smokers with extensive disease (ED)–small cell lung cancer (SCLC).
Materials and Methods
This is an open-label randomized phase II study conducted in National Cancer Center (Goyang, Korea). Chemonaive patients with ED-SCLC, smoking history (≥100 cigarettes lifetime), and Eastern Cooperative Oncology Group performance status of ≤ 2 were eligible. Patients were randomized to receive irinotecan plus cisplatin alone or with simvastatin (40 mg once daily orally) for a maximum of six cycles. Primary endpoint was the the 1-year survival rate.
Between September 16, 2011, and September 9, 2021, 125 patients were randomly assigned to the simvastatin (n=62) or control (n=63) groups. The median smoking pack-year was 40 years. There was no significant difference in the 1-year survival rate between the simvastatin and control groups (53.2% vs. 58.7%, p=0.535). The median progression-free survival and overall survival between the simvastatin arm vs. the control groups were 6.3 months vs. 6.4 months (p=0.686), and 14.4 months vs. 15.2 months, respectively (p=0.749). The incidence of grade 3–4 adverse events was 62.9% in the simvastatin group and 61.9 % in the control groups. In the exploratory analysis of lipid profiles, patients with hypertriglyceridemia had significantly higher 1-year survival rates than those with normal triglyceride levels (80.0% vs. 52.7%, p=0.046).
Addition of simvastatin to chemotherapy provided no survival benefit in ever-smokers with ED-SCLC. Hypertriglyceridemia may be associated with better prognosis in these patient population.
Key words: Small Cell Lung Cancer, Statin, Smokers, Triglycerides, Irinotecan
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