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In this multicenter, randomized, open\u2010label trial, 102 patients were assigned 1:1 to receive either MTX\u2010TMPs intrapleural perfusion (50\u2009mL daily for 4\u2009days) plus ST (cohort 1) or interleukin\u20102 (IL\u20102) intrapleural perfusion (50\u2009mL every 3\u2009days 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%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.025), as was DCR (92.0% vs. 70.7%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.012). Among 83 patients included in the survival analysis, the median overall survival (OS) was 15.0\u2009months (95% CI: 9.2\u201326.9) in cohort 1 and 6.9\u2009months (95% CI: 5.3\u201315.8) in cohort 2 (HR\u2009=\u20090.75; 95% CI: 0.46\u20131.24;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.266). One\u2010, two\u2010, and three\u2010year 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\u2010related adverse events. These findings suggest that intrapleural perfusion of MTX\u2010TMPs combined with ST represents a promising and safe strategy for the management of MPE in patients with lung or breast cancer.\n                  <\/jats:p>","DOI":"10.1002\/ijc.70094","type":"journal-article","created":{"date-parts":[[2025,8,16]],"date-time":"2025-08-16T15:25:09Z","timestamp":1755357909000},"page":"172-181","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A multicenter randomized controlled trial of intrapleural perfusion of methotrexate\u2010loaded tumor cell\u2010derived microparticles combined with systemic therapy for malignant pleural effusion"],"prefix":"10.1002","volume":"158","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9392-8259","authenticated-orcid":false,"given":"Cheng","family":"Zeng","sequence":"first","affiliation":[{"name":"Department of Medical Oncology National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8781-1209","authenticated-orcid":false,"given":"Yujing","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhimin","family":"Jiao","sequence":"additional","affiliation":[{"name":"Department of Internal Oncology Anyang City Cancer Hospital  Anyang Henan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Hubei Province Cancer Hospital  Wuhan Hubei Province 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