Wenting Chen, Jianhua You, Li'e Lin, Xiaojing Yan, Gang An, Yafei Wang, Weiwei Tian, Kaiyang Ding, Xi Zhang, Wenming Chen, Yingxue Wang, Baijun Fang, Jing Liu, Weilin Xia, Zhaoyi Feng, Lei Zhou, Zhini Wang, Dan Shen, Gang Liu, Weili Zhao
{"title":"依沙妥昔单抗联合泊马度胺和地塞米松治疗复发和/或难治性多发性骨髓瘤的实际疗效。","authors":"Wenting Chen, Jianhua You, Li'e Lin, Xiaojing Yan, Gang An, Yafei Wang, Weiwei Tian, Kaiyang Ding, Xi Zhang, Wenming Chen, Yingxue Wang, Baijun Fang, Jing Liu, Weilin Xia, Zhaoyi Feng, Lei Zhou, Zhini Wang, Dan Shen, Gang Liu, Weili Zhao","doi":"10.1097/CM9.0000000000003649","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The isatuximab, pomalidomide, and dexamethasone (Isa-Pd) regimen has shown survival benefits for relapsed and/or refractory multiple myeloma (RRMM) in several trials, while evidence of effectiveness and safety among Chinese patients is limited. This study aim to provide real-world evidence of Isa-Pd in Chinese patients with RRMM.</p><p><strong>Methods: </strong>In a prospective observational real-world study (IsaFiRsT), we enrolled Chinese RRMM patients who had received ≥2 prior therapies, including lenalidomide and proteasome inhibitors, and received the Isa-Pd regimen at Shanghai Jiaotong University School of Medicine, Ruijin-Hainan Hospital. A historical cohort of patients with RRMM who had received >1 additional line of treatment after ≥2 prior therapies was retrospectively included. The primary endpoint of the Isa-Pd cohort was the overall response rate (ORR). Inverse probability treatment weighting (IPTW) was used to balance confounding factors between the Isa-Pd cohort and historical cohort.</p><p><strong>Results: </strong>The Isa-Pd cohort comprised 24 patients with RRMM and reported an ORR of 82.6% (19/23, 95% confidence interval [CI]: 61.2-95.0%), a very good partial response or better rate of 73.9% (17/23) and a complete response or better rate of 43.5% (10/23). The median time to first response was 1.2 months (range: 0.9, 3.1 months). The median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached, with a median follow-up of 8.4 months. The 6-month PFS and OS rates were 87.0% and 91.3%, respectively. The IPTW-adjusted ORR in the Isa-Pd cohort was 85.1% compared to 33.4% in the historical cohort, with a risk ratio of 2.55 (95% CI: 1.73-4.12). The most common grade >3 treatment-emergent adverse events in the Isa-Pd cohort were neutrophil count decreased (75.0%, 18/24), white blood cell count decreased (54.2%, 13/24), and anemia (45.8%, 11/24).</p><p><strong>Conclusion: </strong>The IsaFiRsT study reported that Isa-Pd provided a high rate of deep and rapid response in heavily pretreated Chinese RRMM patients, with an acceptable safety profile in a real-world setting, consistent with Isa-Pd trials.</p><p><strong>Registration: </strong>Chinese Clinical Trial Registry (ChiCTR2200062878).</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5000,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world outcomes of isatuximab with pomalidomide and dexamethasone for relapsed and/or refractory multiple myeloma.\",\"authors\":\"Wenting Chen, Jianhua You, Li'e Lin, Xiaojing Yan, Gang An, Yafei Wang, Weiwei Tian, Kaiyang Ding, Xi Zhang, Wenming Chen, Yingxue Wang, Baijun Fang, Jing Liu, Weilin Xia, Zhaoyi Feng, Lei Zhou, Zhini Wang, Dan Shen, Gang Liu, Weili Zhao\",\"doi\":\"10.1097/CM9.0000000000003649\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The isatuximab, pomalidomide, and dexamethasone (Isa-Pd) regimen has shown survival benefits for relapsed and/or refractory multiple myeloma (RRMM) in several trials, while evidence of effectiveness and safety among Chinese patients is limited. This study aim to provide real-world evidence of Isa-Pd in Chinese patients with RRMM.</p><p><strong>Methods: </strong>In a prospective observational real-world study (IsaFiRsT), we enrolled Chinese RRMM patients who had received ≥2 prior therapies, including lenalidomide and proteasome inhibitors, and received the Isa-Pd regimen at Shanghai Jiaotong University School of Medicine, Ruijin-Hainan Hospital. A historical cohort of patients with RRMM who had received >1 additional line of treatment after ≥2 prior therapies was retrospectively included. The primary endpoint of the Isa-Pd cohort was the overall response rate (ORR). Inverse probability treatment weighting (IPTW) was used to balance confounding factors between the Isa-Pd cohort and historical cohort.</p><p><strong>Results: </strong>The Isa-Pd cohort comprised 24 patients with RRMM and reported an ORR of 82.6% (19/23, 95% confidence interval [CI]: 61.2-95.0%), a very good partial response or better rate of 73.9% (17/23) and a complete response or better rate of 43.5% (10/23). The median time to first response was 1.2 months (range: 0.9, 3.1 months). The median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached, with a median follow-up of 8.4 months. The 6-month PFS and OS rates were 87.0% and 91.3%, respectively. The IPTW-adjusted ORR in the Isa-Pd cohort was 85.1% compared to 33.4% in the historical cohort, with a risk ratio of 2.55 (95% CI: 1.73-4.12). The most common grade >3 treatment-emergent adverse events in the Isa-Pd cohort were neutrophil count decreased (75.0%, 18/24), white blood cell count decreased (54.2%, 13/24), and anemia (45.8%, 11/24).</p><p><strong>Conclusion: </strong>The IsaFiRsT study reported that Isa-Pd provided a high rate of deep and rapid response in heavily pretreated Chinese RRMM patients, with an acceptable safety profile in a real-world setting, consistent with Isa-Pd trials.</p><p><strong>Registration: </strong>Chinese Clinical Trial Registry (ChiCTR2200062878).</p>\",\"PeriodicalId\":10183,\"journal\":{\"name\":\"Chinese Medical Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":7.5000,\"publicationDate\":\"2025-05-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese Medical Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/CM9.0000000000003649\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese Medical Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CM9.0000000000003649","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Real-world outcomes of isatuximab with pomalidomide and dexamethasone for relapsed and/or refractory multiple myeloma.
Background: The isatuximab, pomalidomide, and dexamethasone (Isa-Pd) regimen has shown survival benefits for relapsed and/or refractory multiple myeloma (RRMM) in several trials, while evidence of effectiveness and safety among Chinese patients is limited. This study aim to provide real-world evidence of Isa-Pd in Chinese patients with RRMM.
Methods: In a prospective observational real-world study (IsaFiRsT), we enrolled Chinese RRMM patients who had received ≥2 prior therapies, including lenalidomide and proteasome inhibitors, and received the Isa-Pd regimen at Shanghai Jiaotong University School of Medicine, Ruijin-Hainan Hospital. A historical cohort of patients with RRMM who had received >1 additional line of treatment after ≥2 prior therapies was retrospectively included. The primary endpoint of the Isa-Pd cohort was the overall response rate (ORR). Inverse probability treatment weighting (IPTW) was used to balance confounding factors between the Isa-Pd cohort and historical cohort.
Results: The Isa-Pd cohort comprised 24 patients with RRMM and reported an ORR of 82.6% (19/23, 95% confidence interval [CI]: 61.2-95.0%), a very good partial response or better rate of 73.9% (17/23) and a complete response or better rate of 43.5% (10/23). The median time to first response was 1.2 months (range: 0.9, 3.1 months). The median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached, with a median follow-up of 8.4 months. The 6-month PFS and OS rates were 87.0% and 91.3%, respectively. The IPTW-adjusted ORR in the Isa-Pd cohort was 85.1% compared to 33.4% in the historical cohort, with a risk ratio of 2.55 (95% CI: 1.73-4.12). The most common grade >3 treatment-emergent adverse events in the Isa-Pd cohort were neutrophil count decreased (75.0%, 18/24), white blood cell count decreased (54.2%, 13/24), and anemia (45.8%, 11/24).
Conclusion: The IsaFiRsT study reported that Isa-Pd provided a high rate of deep and rapid response in heavily pretreated Chinese RRMM patients, with an acceptable safety profile in a real-world setting, consistent with Isa-Pd trials.
Registration: Chinese Clinical Trial Registry (ChiCTR2200062878).
期刊介绍：
The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.
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