Danilo De Novellis, Daniele Derudas, Donatella Vincelli, Raffaele Fontana, Roberta Della Pepa, Salvatore Palmieri, Fabrizio Accardi, Francesco Rotondo, Emanuela Morelli, Emilia Gigliotta, Daniela Roccotelli, Luana Marano, Maria Lucia Barone, Giusy Cetani, Daniela Esposito, Antonio Lazzaro, Giuseppe Delle Cave, Bianca Serio, Denise Morini, Marika Porrazzo, Eleonora Urciuoli, Chiara Masucci, Fulvia Fanelli, Michela Rizzo, Manuela Arcamone, Fabio Trastulli, Stefano Rocco, Aldo Leone, Rosario Bianco, Flavia Salvatore, Aurora Idato, Maria Sicari, Patrizia Tosi, Maria Gabriella Rascato, Maria Di Perna, Antonietta Pia Falcone, Lucia Morello, Melania Carlisi, Gino Svanera, Mario Annunziata, Ferdinando Frigeri, Catello Califano, Angelo Michele Carella, Gianpaolo Marcacci, Fabrizio Pane, Antonio Maria Risitano, Valentina Giudice, Ciro Botta, Carmine Selleri
{"title":"伊沙妥昔单抗加卡非佐米和地塞米松对复发/难治性多发性骨髓瘤患者的临床疗效","authors":"Danilo De Novellis, Daniele Derudas, Donatella Vincelli, Raffaele Fontana, Roberta Della Pepa, Salvatore Palmieri, Fabrizio Accardi, Francesco Rotondo, Emanuela Morelli, Emilia Gigliotta, Daniela Roccotelli, Luana Marano, Maria Lucia Barone, Giusy Cetani, Daniela Esposito, Antonio Lazzaro, Giuseppe Delle Cave, Bianca Serio, Denise Morini, Marika Porrazzo, Eleonora Urciuoli, Chiara Masucci, Fulvia Fanelli, Michela Rizzo, Manuela Arcamone, Fabio Trastulli, Stefano Rocco, Aldo Leone, Rosario Bianco, Flavia Salvatore, Aurora Idato, Maria Sicari, Patrizia Tosi, Maria Gabriella Rascato, Maria Di Perna, Antonietta Pia Falcone, Lucia Morello, Melania Carlisi, Gino Svanera, Mario Annunziata, Ferdinando Frigeri, Catello Califano, Angelo Michele Carella, Gianpaolo Marcacci, Fabrizio Pane, Antonio Maria Risitano, Valentina Giudice, Ciro Botta, Carmine Selleri","doi":"10.1111/ejh.14314","DOIUrl":null,"url":null,"abstract":"<p>Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (<i>N</i> = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.</p>","PeriodicalId":11955,"journal":{"name":"European Journal of Haematology","volume":"114 1","pages":"105-114"},"PeriodicalIF":2.3000,"publicationDate":"2024-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ejh.14314","citationCount":"0","resultStr":"{\"title\":\"Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients\",\"authors\":\"Danilo De Novellis, Daniele Derudas, Donatella Vincelli, Raffaele Fontana, Roberta Della Pepa, Salvatore Palmieri, Fabrizio Accardi, Francesco Rotondo, Emanuela Morelli, Emilia Gigliotta, Daniela Roccotelli, Luana Marano, Maria Lucia Barone, Giusy Cetani, Daniela Esposito, Antonio Lazzaro, Giuseppe Delle Cave, Bianca Serio, Denise Morini, Marika Porrazzo, Eleonora Urciuoli, Chiara Masucci, Fulvia Fanelli, Michela Rizzo, Manuela Arcamone, Fabio Trastulli, Stefano Rocco, Aldo Leone, Rosario Bianco, Flavia Salvatore, Aurora Idato, Maria Sicari, Patrizia Tosi, Maria Gabriella Rascato, Maria Di Perna, Antonietta Pia Falcone, Lucia Morello, Melania Carlisi, Gino Svanera, Mario Annunziata, Ferdinando Frigeri, Catello Califano, Angelo Michele Carella, Gianpaolo Marcacci, Fabrizio Pane, Antonio Maria Risitano, Valentina Giudice, Ciro Botta, Carmine Selleri\",\"doi\":\"10.1111/ejh.14314\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (<i>N</i> = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.</p>\",\"PeriodicalId\":11955,\"journal\":{\"name\":\"European Journal of Haematology\",\"volume\":\"114 1\",\"pages\":\"105-114\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-10-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ejh.14314\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Haematology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/ejh.14314\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Haematology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/ejh.14314","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients
Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (N = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.
期刊介绍:
European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.