Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy

Monica Bocchia, Anna Candoni, Erika Borlenghi, Marzia Defina, Carla Filì, Chiara Cattaneo, Vincenzo Sammartano, Renato Fanin, Margherita Sciumè, Anna Sicuranza, Silvia Imbergamo, Marta Riva, Nicola Fracchiolla, Roberto Latagliata, Emanuela Caizzi, Francesco Mazziotta, Giulia Alunni, Eros Di Bona, Monica Crugnola, Marianna RossiUgo Consoli, Giulia Fontanelli, Giuseppina Greco, Gianpaolo Nadali, Francesco Rotondo, Elisabetta Todisco, Catia Bigazzi, Enrico Capochiani, Alfredo Molteni, Massimo Bernardi, Monica Fumagalli, Michela Rondoni, Barbara Scappini, Anna Ermacora, Federico Simonetti, Michele Gottardi, Daniela Lambertenghi Deliliers, Mariagrazia Michieli, Claudia Basilico, Carlotta Galeone, Claudio Pelucchi, Giuseppe Rossi

Research output: Contribution to journalArticle

Abstract

Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m2/iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 10 months for patients with favourable-intermediate cytogenetic risk and 6 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival.

Original languageEnglish
Pages (from-to)447-455
JournalHematological Oncology
Volume37
Issue number4
DOIs
Publication statusPublished - Jan 1 2019

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decitabine
Acute Myeloid Leukemia
Drug Therapy
Cytogenetics
Confidence Intervals
Therapeutics
Leukocyte Count
Survival
Mortality
Italy
Observational Studies

Keywords

  • acute myeloid leukaemia
  • decitabine
  • first-line therapy
  • unfit patients

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy. / Bocchia, Monica; Candoni, Anna; Borlenghi, Erika; Defina, Marzia; Filì, Carla; Cattaneo, Chiara; Sammartano, Vincenzo; Fanin, Renato; Sciumè, Margherita; Sicuranza, Anna; Imbergamo, Silvia; Riva, Marta; Fracchiolla, Nicola; Latagliata, Roberto; Caizzi, Emanuela; Mazziotta, Francesco; Alunni, Giulia; Di Bona, Eros; Crugnola, Monica; Rossi, Marianna; Consoli, Ugo; Fontanelli, Giulia; Greco, Giuseppina; Nadali, Gianpaolo; Rotondo, Francesco; Todisco, Elisabetta; Bigazzi, Catia; Capochiani, Enrico; Molteni, Alfredo; Bernardi, Massimo; Fumagalli, Monica; Rondoni, Michela; Scappini, Barbara; Ermacora, Anna; Simonetti, Federico; Gottardi, Michele; Lambertenghi Deliliers, Daniela; Michieli, Mariagrazia; Basilico, Claudia; Galeone, Carlotta; Pelucchi, Claudio; Rossi, Giuseppe.

In: Hematological Oncology, Vol. 37, No. 4, 01.01.2019, p. 447-455.

Research output: Contribution to journalArticle

Bocchia, M, Candoni, A, Borlenghi, E, Defina, M, Filì, C, Cattaneo, C, Sammartano, V, Fanin, R, Sciumè, M, Sicuranza, A, Imbergamo, S, Riva, M, Fracchiolla, N, Latagliata, R, Caizzi, E, Mazziotta, F, Alunni, G, Di Bona, E, Crugnola, M, Rossi, M, Consoli, U, Fontanelli, G, Greco, G, Nadali, G, Rotondo, F, Todisco, E, Bigazzi, C, Capochiani, E, Molteni, A, Bernardi, M, Fumagalli, M, Rondoni, M, Scappini, B, Ermacora, A, Simonetti, F, Gottardi, M, Lambertenghi Deliliers, D, Michieli, M, Basilico, C, Galeone, C, Pelucchi, C & Rossi, G 2019, 'Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy', Hematological Oncology, vol. 37, no. 4, pp. 447-455. https://doi.org/10.1002/hon.2663
Bocchia, Monica ; Candoni, Anna ; Borlenghi, Erika ; Defina, Marzia ; Filì, Carla ; Cattaneo, Chiara ; Sammartano, Vincenzo ; Fanin, Renato ; Sciumè, Margherita ; Sicuranza, Anna ; Imbergamo, Silvia ; Riva, Marta ; Fracchiolla, Nicola ; Latagliata, Roberto ; Caizzi, Emanuela ; Mazziotta, Francesco ; Alunni, Giulia ; Di Bona, Eros ; Crugnola, Monica ; Rossi, Marianna ; Consoli, Ugo ; Fontanelli, Giulia ; Greco, Giuseppina ; Nadali, Gianpaolo ; Rotondo, Francesco ; Todisco, Elisabetta ; Bigazzi, Catia ; Capochiani, Enrico ; Molteni, Alfredo ; Bernardi, Massimo ; Fumagalli, Monica ; Rondoni, Michela ; Scappini, Barbara ; Ermacora, Anna ; Simonetti, Federico ; Gottardi, Michele ; Lambertenghi Deliliers, Daniela ; Michieli, Mariagrazia ; Basilico, Claudia ; Galeone, Carlotta ; Pelucchi, Claudio ; Rossi, Giuseppe. / Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy. In: Hematological Oncology. 2019 ; Vol. 37, No. 4. pp. 447-455.
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T1 - Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy

AU - Bocchia, Monica

AU - Candoni, Anna

AU - Borlenghi, Erika

AU - Defina, Marzia

AU - Filì, Carla

AU - Cattaneo, Chiara

AU - Sammartano, Vincenzo

AU - Fanin, Renato

AU - Sciumè, Margherita

AU - Sicuranza, Anna

AU - Imbergamo, Silvia

AU - Riva, Marta

AU - Fracchiolla, Nicola

AU - Latagliata, Roberto

AU - Caizzi, Emanuela

AU - Mazziotta, Francesco

AU - Alunni, Giulia

AU - Di Bona, Eros

AU - Crugnola, Monica

AU - Rossi, Marianna

AU - Consoli, Ugo

AU - Fontanelli, Giulia

AU - Greco, Giuseppina

AU - Nadali, Gianpaolo

AU - Rotondo, Francesco

AU - Todisco, Elisabetta

AU - Bigazzi, Catia

AU - Capochiani, Enrico

AU - Molteni, Alfredo

AU - Bernardi, Massimo

AU - Fumagalli, Monica

AU - Rondoni, Michela

AU - Scappini, Barbara

AU - Ermacora, Anna

AU - Simonetti, Federico

AU - Gottardi, Michele

AU - Lambertenghi Deliliers, Daniela

AU - Michieli, Mariagrazia

AU - Basilico, Claudia

AU - Galeone, Carlotta

AU - Pelucchi, Claudio

AU - Rossi, Giuseppe

PY - 2019/1/1

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N2 - Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m2/iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 10 months for patients with favourable-intermediate cytogenetic risk and 6 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival.

AB - Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m2/iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 10 months for patients with favourable-intermediate cytogenetic risk and 6 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival.

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