BMC medicine · 2026
Efficacy and safety of albumin-bound paclitaxel combined with simvastatin in the second-line treatment of small cell lung cancer: a phase II randomized controlled trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Guan Maoying, Zhao Wencheng, Zhang Wengang, Chen Xuyang, Huang Runze, Liu Xinyue, Li Yujie, Wang Hao, Zhao Lishu, Xu Kandi, Ye Li, Chen Zhimin, Liu Yujin, Zhang Qianqian, Ji Hongbin, He Yayi
Аннотация
BACKGROUND: Small-cell lung cancer (SCLC) responds to first-line therapy, but most patients rapidly develop resistance. This study aimed to investigate the efficacy and safety of nab-paclitaxel combined with simvastatin as second-line treatment for SCLC patients.
METHODS: In this phase II randomized trial, patients received nab-paclitaxel alone or in combination with simvastatin. The primary endpoint was disease control rate (DCR); secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: DCR was higher for the nab-paclitaxel plus simvastatin group than in the nab-paclitaxel group (92.9% vs. 44.4%, P = 0.005). ORR (50.0% vs. 11.1%, P = 0.017) and median PFS (113 vs. 62 days; HR = 0.42, 95% CI = 0.19-0.92; P = 0.029) were also improved. No significant difference in OS was observed. Treatment-related toxicities were manageable in both groups.
CONCLUSIONS: In this phase II randomized study, nab-paclitaxel plus simvastatin was associated with improved DCR, ORR, and PFS, with manageable toxicity, as second-line treatment for patients with small-cell lung cancer.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04698941.
METHODS: In this phase II randomized trial, patients received nab-paclitaxel alone or in combination with simvastatin. The primary endpoint was disease control rate (DCR); secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: DCR was higher for the nab-paclitaxel plus simvastatin group than in the nab-paclitaxel group (92.9% vs. 44.4%, P = 0.005). ORR (50.0% vs. 11.1%, P = 0.017) and median PFS (113 vs. 62 days; HR = 0.42, 95% CI = 0.19-0.92; P = 0.029) were also improved. No significant difference in OS was observed. Treatment-related toxicities were manageable in both groups.
CONCLUSIONS: In this phase II randomized study, nab-paclitaxel plus simvastatin was associated with improved DCR, ORR, and PFS, with manageable toxicity, as second-line treatment for patients with small-cell lung cancer.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04698941.