Doris K Hansen, Lauren C Peres, Danai Dima, Alicia Richards, Leyla Shune, Aimaz Afrough, Shonali Midha, Binod Dhakal, Mehmet H Kocoglu, Shebli Atrash, Christopher Ferreri, Omar Castaneda, James A Davis, Evguenia Bhurtel, Joseph McGuirk, Charlotte Wagner, Radhika Bansal, Patrick Costello, Kinaya Smith, Alex Lieberman-Cribbin, Gabriel De Avila, Sneha Purvey, Hitomi Hosoya, Lekha Mikkilineni, Laura B Oswald, Gurbakhash Kaur, Oren Pasvolsky, Mahmoud Gaballa, Megan M Herr, Peter Forsberg, Murali Janakiram, Myo Htut, Sireesha Asoori Maringanti, Nilesh Kalariya, Hamza Hashmi, Ran Reshef, Douglas W Sborov, Omar Nadeem, Faiz Anwer, Jack Khouri, Shahzad Raza, Djordje Atanackovic, Melissa Alsina, Ciara L Freeman, Frederick L Locke, Peter Voorhees, Larry D Anderson, Shambavi Richard, Thomas Martin, Yi Lin, Krina K Patel, Surbhi Sidana
{"title":"治疗复发/难治性多发性骨髓瘤的标准治疗方案——西他他烯维鲁和西他他烯自鲁的比较。","authors":"Doris K Hansen, Lauren C Peres, Danai Dima, Alicia Richards, Leyla Shune, Aimaz Afrough, Shonali Midha, Binod Dhakal, Mehmet H Kocoglu, Shebli Atrash, Christopher Ferreri, Omar Castaneda, James A Davis, Evguenia Bhurtel, Joseph McGuirk, Charlotte Wagner, Radhika Bansal, Patrick Costello, Kinaya Smith, Alex Lieberman-Cribbin, Gabriel De Avila, Sneha Purvey, Hitomi Hosoya, Lekha Mikkilineni, Laura B Oswald, Gurbakhash Kaur, Oren Pasvolsky, Mahmoud Gaballa, Megan M Herr, Peter Forsberg, Murali Janakiram, Myo Htut, Sireesha Asoori Maringanti, Nilesh Kalariya, Hamza Hashmi, Ran Reshef, Douglas W Sborov, Omar Nadeem, Faiz Anwer, Jack Khouri, Shahzad Raza, Djordje Atanackovic, Melissa Alsina, Ciara L Freeman, Frederick L Locke, Peter Voorhees, Larry D Anderson, Shambavi Richard, Thomas Martin, Yi Lin, Krina K Patel, Surbhi Sidana","doi":"10.1200/JCO-24-01730","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.</p><p><strong>Methods: </strong>Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.</p><p><strong>Results: </strong>A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade ≥3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses (≥complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell-associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel (≥March 2022).</p><p><strong>Conclusion: </strong>Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1597-1609"},"PeriodicalIF":42.1000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037312/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma.\",\"authors\":\"Doris K Hansen, Lauren C Peres, Danai Dima, Alicia Richards, Leyla Shune, Aimaz Afrough, Shonali Midha, Binod Dhakal, Mehmet H Kocoglu, Shebli Atrash, Christopher Ferreri, Omar Castaneda, James A Davis, Evguenia Bhurtel, Joseph McGuirk, Charlotte Wagner, Radhika Bansal, Patrick Costello, Kinaya Smith, Alex Lieberman-Cribbin, Gabriel De Avila, Sneha Purvey, Hitomi Hosoya, Lekha Mikkilineni, Laura B Oswald, Gurbakhash Kaur, Oren Pasvolsky, Mahmoud Gaballa, Megan M Herr, Peter Forsberg, Murali Janakiram, Myo Htut, Sireesha Asoori Maringanti, Nilesh Kalariya, Hamza Hashmi, Ran Reshef, Douglas W Sborov, Omar Nadeem, Faiz Anwer, Jack Khouri, Shahzad Raza, Djordje Atanackovic, Melissa Alsina, Ciara L Freeman, Frederick L Locke, Peter Voorhees, Larry D Anderson, Shambavi Richard, Thomas Martin, Yi Lin, Krina K Patel, Surbhi Sidana\",\"doi\":\"10.1200/JCO-24-01730\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.</p><p><strong>Methods: </strong>Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.</p><p><strong>Results: </strong>A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade ≥3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses (≥complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell-associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel (≥March 2022).</p><p><strong>Conclusion: </strong>Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"1597-1609\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037312/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO-24-01730\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/18 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO-24-01730","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma.
Purpose: Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.
Methods: Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.
Results: A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade ≥3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses (≥complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell-associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel (≥March 2022).
Conclusion: Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.
期刊介绍：
The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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