Randomized trial comparing standard vs sequential high-dose chemotherapy for inducing early CR in adult AML
| Autor: | Arianna Masciulli, Irene Cavattoni, Anna Maria Scattolin, Pamela Zanghì, Dario Ferrero, Lorella De Paoli, Chiara Cattaneo, Paolo Corradini, Elisabetta Terruzzi, Erika Borlenghi, Orietta Spinelli, Elisabetta Todisco, Brunangelo Falini, Agostino Cortelezzi, Chiara Pavoni, Sergio Cortelazzo, Giacomo Gianfaldoni, Alessandro Rambaldi, Filippo Marmont, Tamara Intermesoli, Daniele Mattei, Cristina Boschini, Elena Oldani, Renato Bassan, Fabio Ciceri, Massimo Bernardi, Ernesta Audisio, Enrico Pogliani, Leonardo Campiotti, Alberto Bosi |
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| Přispěvatelé: | Bassan, Renato, Intermesoli, Tamara, Masciulli, Arianna, Pavoni, Chiara, Boschini, Cristina, Gianfaldoni, Giacomo, Marmont, Filippo, Cavattoni, Irene, Mattei, Daniele, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Ciceri, Fabio, Bernardi, Massimo, Scattolin, Anna M, Todisco, Elisabetta, Campiotti, Leonardo, Corradini, Paolo, Cortelezzi, Agostino, Ferrero, Dario, Zanghì, Pamela, Oldani, Elena, Spinelli, Orietta, Audisio, Ernesta, Cortelazzo, Sergio, Bosi, Alberto, Falini, Brunangelo, Pogliani, Enrico M, Rambaldi, Alessandro |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization Adolescent Clinical Trials and Observations medicine.medical_treatment Gastroenterology Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Idarubicin Humans Aged Etoposide Chemotherapy business.industry Hazard ratio Remission Induction Cytarabine Hematopoietic Stem Cell Transplantation Hematology Odds ratio Induction Chemotherapy Middle Aged Chemotherapy regimen Survival Analysis Confidence interval Leukemia Myeloid Acute Female business medicine.drug |
| Popis: | Here we evaluated whether sequential high-dose chemotherapy (sHD) increased the early complete remission (CR) rate in acute myelogenous leukemia (AML) compared with standard-intensity idarubicin-cytarabine-etoposide (ICE) chemotherapy. This study enrolled 574 patients (age, 16-73 years; median, 52 years) who were randomly assigned to ICE (n = 286 evaluable) or sHD (2 weekly 3-day blocks with cytarabine 2 g/m2 twice a day for 2 days plus idarubicin; n = 286 evaluable). Responsive patients were risk-stratified for a second randomization. Standard-risk patients received autograft or repetitive blood stem cell-supported high-dose courses. High-risk patients (and standard-risk patients not mobilizing stem cells) underwent allotransplantation. CR rates after 2 induction courses were comparable between ICE (80.8%) and sHD (83.6%; P = .38). sHD yielded a higher single-induction CR rate (69.2% vs 81.5%; P = .0007) with lower resistance risk (P < .0001), comparable mortality (P = .39), and improved 5-year overall survival (39% vs 49%; P = .045) and relapse-free survival (36% vs 48%; P = .028), despite greater hematotoxicity delaying or reducing consolidation blocks. sHD improved the early CR rate in high-risk AML (odds ratio, 0.48; 95% confidence interval [CI], 0.31-0.74; P = .0008) and in patients aged 60 years and less with de novo AML (odds ratio, 0.46; 95% CI, 0.27-0.78; P = .003), and also improved overall/relapse-free survival in the latter group (hazard ratio, 0.70; 95% CI, 0.52-0.94; P = .01), in standard-risk AML, and postallograft (hazard ratio, 0.61; 95% CI, 0.39-0.96; P = .03). sHD was feasible, effectively achieved rapid CR, and improved outcomes in AML subsets. This study is registered at www.clinicaltrials.gov as #NCT00495287. |
| Databáze: | OpenAIRE |
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