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Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients

Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial. We conducted a population-based cohort...

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Autores principales: Østgård, Lene Sofie Granfeldt, Nørgaard, Mette, Sengeløv, Henrik, Medeiros, Bruno C., Kjeldsen, Lars, Overgaard, Ulrik Malthe, Severinsen, Marianne Tang, Marcher, Claus Werenberg, Jensen, Morten Krogh, Nørgaard, Jan Maxwell
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Impact Journals LLC 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5342143/
https://www.ncbi.nlm.nih.gov/pubmed/27732947
http://dx.doi.org/10.18632/oncotarget.12495
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author Østgård, Lene Sofie Granfeldt
Nørgaard, Mette
Sengeløv, Henrik
Medeiros, Bruno C.
Kjeldsen, Lars
Overgaard, Ulrik Malthe
Severinsen, Marianne Tang
Marcher, Claus Werenberg
Jensen, Morten Krogh
Nørgaard, Jan Maxwell
author_facet Østgård, Lene Sofie Granfeldt
Nørgaard, Mette
Sengeløv, Henrik
Medeiros, Bruno C.
Kjeldsen, Lars
Overgaard, Ulrik Malthe
Severinsen, Marianne Tang
Marcher, Claus Werenberg
Jensen, Morten Krogh
Nørgaard, Jan Maxwell
author_sort Østgård, Lene Sofie Granfeldt
collection PubMed
description Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial. We conducted a population-based cohort study of newly diagnosed Danish AML patients treated with intensive chemotherapy between 2000–2013. We estimated accrual rates and compared characteristics, complete remission (CR) rates, and relative risks (RRs) of death at 90-day, 1-year, and 3-years in clinical trial patients to patients treated off-trial. Of 867 patients, 58.3% (n = 504) were included in a clinical trial. Accrual rates were similar across age groups (p = 0.55). Patients with poor performance status, comorbidity, therapy-related and secondary AML were less likely to be enrolled in trials. CR rates were 80.2% in trial-patients versus 68.6% in patients treated off- trial. Also, trial-patients had superior survival at 1-year; 72%, vs. 54% (adjusted RR of death 1.28(CI = 1.06–1.54)), and at 3 years; 45% vs. 29% (adjusted RR 1.14(CI = 1.03–1.26)) compared to patients treated off-trial. Despite high accrual rates, patients enrolled in clinical trials had a favorable prognostic profile and a better survival than patients treated off-trial. In conclusion, all trial results should be extrapolated with caution and population-based studies of “real world patients” have a prominent role in examining the prognosis of AML.
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spelling pubmed-53421432017-03-24 Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients Østgård, Lene Sofie Granfeldt Nørgaard, Mette Sengeløv, Henrik Medeiros, Bruno C. Kjeldsen, Lars Overgaard, Ulrik Malthe Severinsen, Marianne Tang Marcher, Claus Werenberg Jensen, Morten Krogh Nørgaard, Jan Maxwell Oncotarget Research Paper Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial. We conducted a population-based cohort study of newly diagnosed Danish AML patients treated with intensive chemotherapy between 2000–2013. We estimated accrual rates and compared characteristics, complete remission (CR) rates, and relative risks (RRs) of death at 90-day, 1-year, and 3-years in clinical trial patients to patients treated off-trial. Of 867 patients, 58.3% (n = 504) were included in a clinical trial. Accrual rates were similar across age groups (p = 0.55). Patients with poor performance status, comorbidity, therapy-related and secondary AML were less likely to be enrolled in trials. CR rates were 80.2% in trial-patients versus 68.6% in patients treated off- trial. Also, trial-patients had superior survival at 1-year; 72%, vs. 54% (adjusted RR of death 1.28(CI = 1.06–1.54)), and at 3 years; 45% vs. 29% (adjusted RR 1.14(CI = 1.03–1.26)) compared to patients treated off-trial. Despite high accrual rates, patients enrolled in clinical trials had a favorable prognostic profile and a better survival than patients treated off-trial. In conclusion, all trial results should be extrapolated with caution and population-based studies of “real world patients” have a prominent role in examining the prognosis of AML. Impact Journals LLC 2016-10-06 /pmc/articles/PMC5342143/ /pubmed/27732947 http://dx.doi.org/10.18632/oncotarget.12495 Text en Copyright: © 2016 Østgård et al. http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Paper
Østgård, Lene Sofie Granfeldt
Nørgaard, Mette
Sengeløv, Henrik
Medeiros, Bruno C.
Kjeldsen, Lars
Overgaard, Ulrik Malthe
Severinsen, Marianne Tang
Marcher, Claus Werenberg
Jensen, Morten Krogh
Nørgaard, Jan Maxwell
Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title_full Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title_fullStr Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title_full_unstemmed Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title_short Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients
title_sort improved outcome in acute myeloid leukemia patients enrolled in clinical trials: a national population-based cohort study of danish intensive chemotherapy patients
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5342143/
https://www.ncbi.nlm.nih.gov/pubmed/27732947
http://dx.doi.org/10.18632/oncotarget.12495
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