A multicenter randomized controlled trial of intrapleural perfusion of methotrexate‐loaded tumor cell‐derived microparticles combined with systemic therapy for malignant pleural effusion

This study evaluated the efficacy and safety of intrapleural perfusion with methotrexate-loaded tumor cell-derived microparticles (MTX-TMPs) combined with systemic therapy (ST) in patients with malignant pleural effusion (MPE) secondary to lung or breast cancer. In this multicenter, randomized, open-label trial, 102 patients were assigned 1:1 to receive either MTX-TMPs intrapleural perfusion (50 mL daily for 4 days) plus ST (cohort 1) or interleukin-2 (IL-2) intrapleural perfusion (50 mL every 3 days for three sessions) plus ST (cohort 2). The objective response rate (ORR) and disease control rate (DCR) of pleural effusion were evaluated in 91 patients (50 in cohort 1, 41 in cohort 2). ORR was significantly higher in cohort 1 than in cohort 2 (76.0% vs. 53.7%, p = 0.025), as was DCR (92.0% vs. 70.7%, p = 0.012). Among 83 patients included in the survival analysis, the median overall survival (OS) was 15.0 months (95% CI: 9.2-26.9) in cohort 1 and 6.9 months (95% CI: 5.3-15.8) in cohort 2 (HR = 0.75; 95% CI: 0.46-1.24; p = 0.266). One-, two-, and three-year OS rates in cohort 1 were 55.3%, 36.2%, and 25.5%, compared to 38.9%, 25.0%, and 25.0% in cohort 2. Both regimens showed manageable safety profiles, with anemia, pyrexia, fatigue, leukopenia, gastrointestinal symptoms, and liver dysfunction being the most common treatment-related adverse events. These findings suggest that intrapleural perfusion of MTX-TMPs combined with ST represents a promising and safe strategy for the management of MPE in patients with lung or breast cancer.

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Publication Details

Journal
International Journal of Cancer
Published
2025-08-16
DOI
https://doi.org/10.1002/ijc.70094
Primary Topic
Pleural and Pulmonary Diseases
Type
article
Field-Weighted Citation Impact
0.00

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article

A multicenter randomized controlled trial of intrapleural perfusion of methotrexate‐loaded tumor cell‐derived microparticles combined with systemic therapy for malignant pleural effusion

Tienan Yi, Fei Ma, Hu Liu, Yujing Tan et al.
International Journal of Cancer
Pleural and Pulmonary Diseases
article

A multicenter randomized controlled trial of intrapleural perfusion of methotrexate‐loaded tumor cell‐derived microparticles combined with systemic therapy for malignant pleural effusion

Tienan Yi, Fei Ma, Hu Liu, Yujing Tan, Guohua Yu, Ping Sun, Z. Wang, Hongyan Jin, Sanyuan Tang, Zhimin Jiao, Xinyan Liu, Yan Zhang, Jiming Chen, Jiani Wang, Mengxian Zhang, Cheng Zeng, Jingyan Zhu, Sheng Hu, Qingming Shi, Ting Zhu, Mei Cai
article en

Abstract

This study evaluated the efficacy and safety of intrapleural perfusion with methotrexate-loaded tumor cell-derived microparticles (MTX-TMPs) combined with systemic therapy (ST) in patients with malignant pleural effusion (MPE) secondary to lung or breast cancer. In this multicenter, randomized, open-label trial, 102 patients were assigned 1:1 to receive either MTX-TMPs intrapleural perfusion (50 mL daily for 4 days) plus ST (cohort 1) or interleukin-2 (IL-2) intrapleural perfusion (50 mL every 3 days for three sessions) plus ST (cohort 2). The objective response rate (ORR) and disease control rate (DCR) of pleural effusion were evaluated in 91 patients (50 in cohort 1, 41 in cohort 2). ORR was significantly higher in cohort 1 than in cohort 2 (76.0% vs. 53.7%, p = 0.025), as was DCR (92.0% vs. 70.7%, p = 0.012). Among 83 patients included in the survival analysis, the median overall survival (OS) was 15.0 months (95% CI: 9.2-26.9) in cohort 1 and 6.9 months (95% CI: 5.3-15.8) in cohort 2 (HR = 0.75; 95% CI: 0.46-1.24; p = 0.266). One-, two-, and three-year OS rates in cohort 1 were 55.3%, 36.2%, and 25.5%, compared to 38.9%, 25.0%, and 25.0% in cohort 2. Both regimens showed manageable safety profiles, with anemia, pyrexia, fatigue, leukopenia, gastrointestinal symptoms, and liver dysfunction being the most common treatment-related adverse events. These findings suggest that intrapleural perfusion of MTX-TMPs combined with ST represents a promising and safe strategy for the management of MPE in patients with lung or breast cancer.

International Journal of CancerVol. 158(1)
Hebei Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Yuhuangding Hospital (CN), Hospital of Hebei Province (CN), Wuhan Puai Hospital (CN), Shanxi Provincial Cancer Hospital (CN), Second People Hospital of Hunan (CN), Fourth Hospital of Hebei Medical University (CN), Hebei General Hospital (CN), Weifang People's Hospital (CN), Xiangyang Central Hospital (CN), Hunan Academy of Traditional Chinese Medicine (CN), First Hospital of Shijiazhuang (CN), Anhui Provincial Hospital (CN), Anhui Mental Health Center (CN), Shanxi Academy of Medical Sciences (CN), Weifang Chinese Medicine Hospital (CN), Hubei Cancer Hospital (CN), Anyang Tumor Hospital (CN), Union Hospital (CN), Hefei First People's Hospital (CN)
National Natural Science Foundation of China, Peking Union Medical College, National Science and Technology Major Project, Bijzonder Onderzoeksfonds UGent
Good health and well-being
Openalex Percentile: Top 69%
Pleural and Pulmonary Diseases
DOIOpen Access PDFOpenAlex
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