Jessica S W Borgers, Theresa M Medina, William A Robinson, Kasey L Couts, Elizabeth N Katsnelson, Claire M Muckle, Eduardo Davilla, Sapna P Patel, Dexiang Gao, Richard P Tobin, Martin D McCarter
{"title":"派姆单抗和全反式维甲酸联合治疗晚期黑色素瘤:长期生存更新","authors":"Jessica S W Borgers, Theresa M Medina, William A Robinson, Kasey L Couts, Elizabeth N Katsnelson, Claire M Muckle, Eduardo Davilla, Sapna P Patel, Dexiang Gao, Richard P Tobin, Martin D McCarter","doi":"10.1177/17588359251349321","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Primary analysis of the phase I/II clinical trial combining pembrolizumab with all-trans retinoic acid (ATRA) for patients with metastatic melanoma showed a median progression-free survival (PFS) of 20.3 months and median overall survival (OS) not reached.</p><p><strong>Objective: </strong>Report 5-year OS and PFS rates.</p><p><strong>Design: </strong>In this single-center, single-arm trial (NCT03200847), 24 anti-PD-1 naïve patients with metastatic melanoma were enrolled between 10/2017 and 07/2020.</p><p><strong>Methods: </strong>The Kaplan-Meier method was used to estimate OS and PFS.</p><p><strong>Results: </strong>At data cutoff (May 14, 2024), all patients had completed treatment, and 58% (<i>n</i> = 14) remained alive with a median follow-up of 48 months. The updated 5-year OS rate is 54.7% (95% confidence interval (CI): 36.4-82.1), and the 5-year PFS is 36.1% (95% CI: 21.0-62.2), with 33% (<i>n</i> = 8) having an ongoing complete response.</p><p><strong>Conclusion: </strong>These results underscore the long-term clinical benefit of combining anti-PD-1 with ATRA, with survival rates comparable to anti-PD-1/combinations but with lower toxicity.</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"17 ","pages":"17588359251349321"},"PeriodicalIF":4.2000,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12198584/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pembrolizumab and all-trans retinoic acid combination treatment of advanced melanoma: long-term survival update.\",\"authors\":\"Jessica S W Borgers, Theresa M Medina, William A Robinson, Kasey L Couts, Elizabeth N Katsnelson, Claire M Muckle, Eduardo Davilla, Sapna P Patel, Dexiang Gao, Richard P Tobin, Martin D McCarter\",\"doi\":\"10.1177/17588359251349321\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Primary analysis of the phase I/II clinical trial combining pembrolizumab with all-trans retinoic acid (ATRA) for patients with metastatic melanoma showed a median progression-free survival (PFS) of 20.3 months and median overall survival (OS) not reached.</p><p><strong>Objective: </strong>Report 5-year OS and PFS rates.</p><p><strong>Design: </strong>In this single-center, single-arm trial (NCT03200847), 24 anti-PD-1 naïve patients with metastatic melanoma were enrolled between 10/2017 and 07/2020.</p><p><strong>Methods: </strong>The Kaplan-Meier method was used to estimate OS and PFS.</p><p><strong>Results: </strong>At data cutoff (May 14, 2024), all patients had completed treatment, and 58% (<i>n</i> = 14) remained alive with a median follow-up of 48 months. The updated 5-year OS rate is 54.7% (95% confidence interval (CI): 36.4-82.1), and the 5-year PFS is 36.1% (95% CI: 21.0-62.2), with 33% (<i>n</i> = 8) having an ongoing complete response.</p><p><strong>Conclusion: </strong>These results underscore the long-term clinical benefit of combining anti-PD-1 with ATRA, with survival rates comparable to anti-PD-1/combinations but with lower toxicity.</p>\",\"PeriodicalId\":23053,\"journal\":{\"name\":\"Therapeutic Advances in Medical Oncology\",\"volume\":\"17 \",\"pages\":\"17588359251349321\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-06-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12198584/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Medical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17588359251349321\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Medical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17588359251349321","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Pembrolizumab and all-trans retinoic acid combination treatment of advanced melanoma: long-term survival update.
Background: Primary analysis of the phase I/II clinical trial combining pembrolizumab with all-trans retinoic acid (ATRA) for patients with metastatic melanoma showed a median progression-free survival (PFS) of 20.3 months and median overall survival (OS) not reached.
Objective: Report 5-year OS and PFS rates.
Design: In this single-center, single-arm trial (NCT03200847), 24 anti-PD-1 naïve patients with metastatic melanoma were enrolled between 10/2017 and 07/2020.
Methods: The Kaplan-Meier method was used to estimate OS and PFS.
Results: At data cutoff (May 14, 2024), all patients had completed treatment, and 58% (n = 14) remained alive with a median follow-up of 48 months. The updated 5-year OS rate is 54.7% (95% confidence interval (CI): 36.4-82.1), and the 5-year PFS is 36.1% (95% CI: 21.0-62.2), with 33% (n = 8) having an ongoing complete response.
Conclusion: These results underscore the long-term clinical benefit of combining anti-PD-1 with ATRA, with survival rates comparable to anti-PD-1/combinations but with lower toxicity.
期刊介绍:
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).