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Background <p>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.</p> Methods <p>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.</p> Results <p>DCR was higher for the nab-paclitaxel plus simvastatin group than in the nab-paclitaxel group (92.9% vs. 44.4%, <i>P</i> = 0.005). ORR (50.0% vs. 11.1%, <i>P</i> = 0.017) and median PFS (113 vs. 62&#xa0;days; HR = 0.42, 95% CI = 0.19–0.92; <i>P</i> = 0.029) were also improved. No significant difference in OS was observed. Treatment-related toxicities were manageable in both groups.</p> Conclusions <p>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.</p> Trial registration <p>ClinicalTrials.gov NCT04698941.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月6日

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  • Maoying Guan,
  • Wencheng Zhao,
  • Wengang Zhang,
  • Xuyang Chen,
  • Runze Huang,
  • Xinyue Liu,
  • Yujie Li,
  • Hao Wang,
  • Lishu Zhao,
  • Kandi Xu,
  • Li Ye,
  • Zhimin Chen,
  • Yujin Liu,
  • Qianqian Zhang,
  • Hongbin Ji,
  • Yayi He

摘要

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.