Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network
Decitabine, a DNA hypomethylating agent, was approved for use in adults with acute myeloid leukemia (AML) not eligible for standard chemotherapy and is now widely accepted as standard treatment. Although a number of clinical trials demonstrated its benefits in elderly AML patients, older adults and...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-02-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/14/3/826 |
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| author | Michelina Dargenio Giuseppe Tarantini Nicola Cascavilla Enzo Pavone Pellegrino Musto Patrizio Mazza Lorella Melillo Domenico Pastore Attilio Guarini Caterina Buquicchio Maria Paola Fina Vincenzo Federico Teresa Maria Santeramo Marina Aurora Urbano Mariangela Leo Vera Carluccio Paola Carluccio Mario Delia Daniela Carlino Carolina Vergine Vito Pier Gagliardi Giuseppina Greco Silvia Sibilla Mariachiara Abbenante Giovanni Rossi Giuseppina Spinosa Annamaria Mazzone Lara Aprile Vincenza de Fazio Crescenza Pasciolla Giorgina Specchia Nicola Di Renzo |
| author_facet | Michelina Dargenio Giuseppe Tarantini Nicola Cascavilla Enzo Pavone Pellegrino Musto Patrizio Mazza Lorella Melillo Domenico Pastore Attilio Guarini Caterina Buquicchio Maria Paola Fina Vincenzo Federico Teresa Maria Santeramo Marina Aurora Urbano Mariangela Leo Vera Carluccio Paola Carluccio Mario Delia Daniela Carlino Carolina Vergine Vito Pier Gagliardi Giuseppina Greco Silvia Sibilla Mariachiara Abbenante Giovanni Rossi Giuseppina Spinosa Annamaria Mazzone Lara Aprile Vincenza de Fazio Crescenza Pasciolla Giorgina Specchia Nicola Di Renzo |
| author_sort | Michelina Dargenio |
| collection | DOAJ |
| description | Decitabine, a DNA hypomethylating agent, was approved for use in adults with acute myeloid leukemia (AML) not eligible for standard chemotherapy and is now widely accepted as standard treatment. Although a number of clinical trials demonstrated its benefits in elderly AML patients, older adults and patients with frequent comorbidities are typically under-represented in such settings. Thus, the aim of the present study is to evaluate, in a real-world setting, the effectiveness and toxicity of decitabine administered as a single agent in unselected previously untreated elderly AML patients not eligible for intensive chemotherapy. In nine hematological departments of the Apulian Hematological Network (REP), we enrolled 199 patients (median age: 75.4 years; range: 61–91) with de novo (<i>n</i> = 94) or secondary/therapy-related (<i>n</i> = 105) AML treated with decitabine 20 mg/m<sup>2</sup> for five days every 4 weeks. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using multivariate Cox regression. The average number of cycles administered per patient was 6.3 (SD: 6.0; median: 5 cycles). Complete response was achieved by 31 patients (15.6%) and partial response by 57 (28.6%), for a total of 88 responders overall (44.2%). After a median follow-up of 33.6 months, median OS was 8.7 months (95% CI: 7.4–10.3), and the 6-month, 1-year, and 3-year OS rates were 62.7%, 37.0%, and 7.1%, respectively. Mortality was increased in AML patients with ≥3 comorbidities (HR = 2.45; 95% CI: 1.18–5.08) vs. no comorbidities and in those with adverse karyotype (HR = 1.58; 95% CI: 1.05–2.38) vs. favourable or intermediate profile. Infection was the main registered adverse event (46.0%). In conclusion, this REP real-life study demonstrates, after a follow-up of almost 3 years, how decitabine administered to AML patients not suitable for intensive chemotherapy is effective and well tolerated, even in a population of truly elderly patients with frequent comorbidities. |
| first_indexed | 2024-03-10T00:05:12Z |
| format | Article |
| id | doaj.art-55e126b1022146328fc02cba542effc6 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T00:05:12Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-55e126b1022146328fc02cba542effc62023-11-23T16:09:17ZengMDPI AGCancers2072-66942022-02-0114382610.3390/cancers14030826Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological NetworkMichelina Dargenio0Giuseppe Tarantini1Nicola Cascavilla2Enzo Pavone3Pellegrino Musto4Patrizio Mazza5Lorella Melillo6Domenico Pastore7Attilio Guarini8Caterina Buquicchio9Maria Paola Fina10Vincenzo Federico11Teresa Maria Santeramo12Marina Aurora Urbano13Mariangela Leo14Vera Carluccio15Paola Carluccio16Mario Delia17Daniela Carlino18Carolina Vergine19Vito Pier Gagliardi20Giuseppina Greco21Silvia Sibilla22Mariachiara Abbenante23Giovanni Rossi24Giuseppina Spinosa25Annamaria Mazzone26Lara Aprile27Vincenza de Fazio28Crescenza Pasciolla29Giorgina Specchia30Nicola Di Renzo31Hematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyHematology Unit, Dimiccoli Hospital, 76121 Barletta, ItalyHematology Unit, IRCCS “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, 71013 Foggia, ItalyHematology and Transplant Unit, Cardinal Panico Hospital, 73039 Tricase, ItalyUnit of Hematology and Stem Cell Transplantation, AOUC Policlinico, 70124 Bari, ItalyHematology Unit, Department of Hematology-Oncology, Moscati Hospital, 74010 Taranto, ItalyHematology Unit, IRCCS “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, 71013 Foggia, ItalyHematology Unit, A. Perrino Hospital, 72100 Brindisi, ItalyHematology Unit, Giovanni Paolo II IRCCS Cancer Institute Oncology Hospital, 70124 Bari, ItalyHematology Unit, Dimiccoli Hospital, 76121 Barletta, ItalyHematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyHematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyHematology Unit, Dimiccoli Hospital, 76121 Barletta, ItalyHematology Unit, A. Perrino Hospital, 72100 Brindisi, ItalyHematology Unit, Dimiccoli Hospital, 76121 Barletta, ItalyHematology Unit, Dimiccoli Hospital, 76121 Barletta, ItalyUnit of Hematology and Stem Cell Transplantation, AOUC Policlinico, 70124 Bari, ItalyUnit of Hematology and Stem Cell Transplantation, AOUC Policlinico, 70124 Bari, ItalyHematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyHematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyUnit of Hematology and Stem Cell Transplantation, AOUC Policlinico, 70124 Bari, ItalyHematology and Transplant Unit, Cardinal Panico Hospital, 73039 Tricase, ItalyHematology and Transplant Unit, Cardinal Panico Hospital, 73039 Tricase, ItalyHematology Unit, IRCCS “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, 71013 Foggia, ItalyHematology Unit, IRCCS “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, 71013 Foggia, ItalyHematology Unit, Azienda Ospedaliero Universitaria—Ospedali Riuniti, 71122 Foggia, ItalyHematology Unit, Department of Hematology-Oncology, Moscati Hospital, 74010 Taranto, ItalyHematology Unit, Department of Hematology-Oncology, Moscati Hospital, 74010 Taranto, ItalyHematology Unit, Giovanni Paolo II IRCCS Cancer Institute Oncology Hospital, 70124 Bari, ItalyHematology Unit, Giovanni Paolo II IRCCS Cancer Institute Oncology Hospital, 70124 Bari, ItalySchool of Medicine, University of Bari “Aldo Moro”, 70124 Bari, ItalyHematology and Stem Cell Transplant Unit, “Vito Fazzi” Hospital, 73100 Lecce, ItalyDecitabine, a DNA hypomethylating agent, was approved for use in adults with acute myeloid leukemia (AML) not eligible for standard chemotherapy and is now widely accepted as standard treatment. Although a number of clinical trials demonstrated its benefits in elderly AML patients, older adults and patients with frequent comorbidities are typically under-represented in such settings. Thus, the aim of the present study is to evaluate, in a real-world setting, the effectiveness and toxicity of decitabine administered as a single agent in unselected previously untreated elderly AML patients not eligible for intensive chemotherapy. In nine hematological departments of the Apulian Hematological Network (REP), we enrolled 199 patients (median age: 75.4 years; range: 61–91) with de novo (<i>n</i> = 94) or secondary/therapy-related (<i>n</i> = 105) AML treated with decitabine 20 mg/m<sup>2</sup> for five days every 4 weeks. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using multivariate Cox regression. The average number of cycles administered per patient was 6.3 (SD: 6.0; median: 5 cycles). Complete response was achieved by 31 patients (15.6%) and partial response by 57 (28.6%), for a total of 88 responders overall (44.2%). After a median follow-up of 33.6 months, median OS was 8.7 months (95% CI: 7.4–10.3), and the 6-month, 1-year, and 3-year OS rates were 62.7%, 37.0%, and 7.1%, respectively. Mortality was increased in AML patients with ≥3 comorbidities (HR = 2.45; 95% CI: 1.18–5.08) vs. no comorbidities and in those with adverse karyotype (HR = 1.58; 95% CI: 1.05–2.38) vs. favourable or intermediate profile. Infection was the main registered adverse event (46.0%). In conclusion, this REP real-life study demonstrates, after a follow-up of almost 3 years, how decitabine administered to AML patients not suitable for intensive chemotherapy is effective and well tolerated, even in a population of truly elderly patients with frequent comorbidities.https://www.mdpi.com/2072-6694/14/3/826acute myeloid leukemiadecitabineelderlyreal-world studytreatment |
| spellingShingle | Michelina Dargenio Giuseppe Tarantini Nicola Cascavilla Enzo Pavone Pellegrino Musto Patrizio Mazza Lorella Melillo Domenico Pastore Attilio Guarini Caterina Buquicchio Maria Paola Fina Vincenzo Federico Teresa Maria Santeramo Marina Aurora Urbano Mariangela Leo Vera Carluccio Paola Carluccio Mario Delia Daniela Carlino Carolina Vergine Vito Pier Gagliardi Giuseppina Greco Silvia Sibilla Mariachiara Abbenante Giovanni Rossi Giuseppina Spinosa Annamaria Mazzone Lara Aprile Vincenza de Fazio Crescenza Pasciolla Giorgina Specchia Nicola Di Renzo Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network Cancers acute myeloid leukemia decitabine elderly real-world study treatment |
| title | Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network |
| title_full | Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network |
| title_fullStr | Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network |
| title_full_unstemmed | Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network |
| title_short | Long-Term Follow-Up of Elderly Patients with Acute Myeloid Leukemia Treated with Decitabine: A Real-World Study of the Apulian Hematological Network |
| title_sort | long term follow up of elderly patients with acute myeloid leukemia treated with decitabine a real world study of the apulian hematological network |
| topic | acute myeloid leukemia decitabine elderly real-world study treatment |
| url | https://www.mdpi.com/2072-6694/14/3/826 |
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