Center for Lung Cancer, National Cancer Center, Goyang, Korea.
Department of Radiology, National Cancer Center, Goyang, Korea.
Cancer Res Treat. 2023 Jul;55(3):885-893. doi: 10.4143/crt.2023.283. Epub 2023 Mar 20.
This study evaluated whether an addition of simvastatin to chemotherapy improves survival in ever-smokers with extensive disease (ED)-small cell lung cancer (SCLC).
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 group. 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.
本研究评估了在广泛期（ED）小细胞肺癌（SCLC）的吸烟患者中，联合辛伐他汀化疗是否能提高生存率。
这是在韩国国Cancer Center（高阳市）进行的一项开放标签、随机的 II 期研究。符合条件的患者为初治的 ED-SCLC 患者，有吸烟史（≥ 100 支香烟/生），Eastern Cooperative Oncology Group 体能状态为 2。患者被随机分为接受伊立替康加顺铂单药治疗或联合辛伐他汀（40 mg 每日一次口服）治疗，最多 6 个周期。主要终点是 1 年生存率。
2011 年 9 月 16 日至 2021 年 9 月 9 日，共 125 例患者被随机分配至辛伐他汀组（n=62）或对照组（n=63）。中位吸烟包年数为 40 年。辛伐他汀组和对照组的 1 年生存率无显著差异（53.2% vs. 58.7%，p=0.535）。辛伐他汀组与对照组中位无进展生存期和总生存期分别为 6.3 个月 vs. 6.4 个月（p=0.686）和 14.4 个月 vs. 15.2 个月（p=0.749）。辛伐他汀组的 3-4 级不良事件发生率为 62.9%，对照组为 61.9%。在血脂谱的探索性分析中，高甘油三酯血症患者的 1 年生存率显著高于正常甘油三酯水平患者（80.0% vs. 52.7%，p=0.046）。
在 ED-SCLC 的吸烟患者中，联合辛伐他汀化疗并未带来生存获益。在这些患者群体中，高甘油三酯血症可能与更好的预后相关。
