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Background <p>The presence of malignant pleural effusion (MPE) remains a challenge in clinical treatment. This study aimed to evaluate the safety and efficacy of intrapleural administration of anti-programmed cell death 1 (PD-1) antibody, specifically targeting patients with advanced non-small cell lung cancer (NSCLC) complicated by MPE.</p> Methods <p>From May 2019 to December 2023, a total of 16 advanced NSCLC patients with MPE were enrolled. Each patient received a single intrapleural dose of 100&#xa0;mg of sintilimab. The primary outcome was safety, while secondary outcomes included the proportion of participants who achieved successful pleurodesis by day 35 and day 70 post-intervention; median pleural progression-free survival (mPPFS); the objective response rate (ORR) of extra-pleural tumor at both day 35 and day 70.</p> Results <p>Among the 16 patients, the proportion of participants with successful pleurodesis at day 35 was 75.0% (12/16), which decreased to 56.3% (9/16) by day 70. The mPPFS was 10.4&#xa0;weeks (95% CI 7.6–13.3&#xa0;weeks). The ORR of extrapleural tumors at day 35 was 12.5%, with 12.5% (2/16) of patients achieving partial remission (PR), 81.3% (13/16) maintaining stable disease (SD), and 6.3% (1/16) experiencing disease progression (PD). As for safety, the treatment-related adverse events (TRAEs) were well-tolerated. However, 93.8% (15/16) patients experienced treatment-emergent adverse events (TEAEs). The incidence rate of grade 3 TEAEs was 25.0% (4/16), and no grade 4 TEAEs occurred in any patients.</p> Conclusions <p>Intrapleural injection of anti-PD-1 antibody demonstrates promising efficacy and a tolerable safety profile as a novel therapeutic strategy for managing MPE in advanced NSCLC.</p> Trial registration <p>This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR2400087743).</p>

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Intrapleural anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a prospective, single-arm, single-center, phase I trial

  • 期刊论文

  • 发表日期：

    2025年10月28日

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  • Yuting Cui,
  • Qiuxia Wu,
  • Yue Hao,
  • Guannan Wu,
  • Qinpei Cheng,
  • Xincui Song,
  • Lu Chen,
  • Xin Hua,
  • Yuxin Jiang,
  • Di Cheng,
  • Suhua Zhu,
  • Xin Liu,
  • Yong Song,
  • Tangfeng Lv,
  • Ping Zhan

摘要

Background

The presence of malignant pleural effusion (MPE) remains a challenge in clinical treatment. This study aimed to evaluate the safety and efficacy of intrapleural administration of anti-programmed cell death 1 (PD-1) antibody, specifically targeting patients with advanced non-small cell lung cancer (NSCLC) complicated by MPE.

Methods

From May 2019 to December 2023, a total of 16 advanced NSCLC patients with MPE were enrolled. Each patient received a single intrapleural dose of 100 mg of sintilimab. The primary outcome was safety, while secondary outcomes included the proportion of participants who achieved successful pleurodesis by day 35 and day 70 post-intervention; median pleural progression-free survival (mPPFS); the objective response rate (ORR) of extra-pleural tumor at both day 35 and day 70.

Results

Among the 16 patients, the proportion of participants with successful pleurodesis at day 35 was 75.0% (12/16), which decreased to 56.3% (9/16) by day 70. The mPPFS was 10.4 weeks (95% CI 7.6–13.3 weeks). The ORR of extrapleural tumors at day 35 was 12.5%, with 12.5% (2/16) of patients achieving partial remission (PR), 81.3% (13/16) maintaining stable disease (SD), and 6.3% (1/16) experiencing disease progression (PD). As for safety, the treatment-related adverse events (TRAEs) were well-tolerated. However, 93.8% (15/16) patients experienced treatment-emergent adverse events (TEAEs). The incidence rate of grade 3 TEAEs was 25.0% (4/16), and no grade 4 TEAEs occurred in any patients.

Conclusions

Intrapleural injection of anti-PD-1 antibody demonstrates promising efficacy and a tolerable safety profile as a novel therapeutic strategy for managing MPE in advanced NSCLC.

Trial registration

This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR2400087743).