Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission
| Autor: | Valentina Giai, Christopher Pocock, C.L. Beach, Lorenza Borin, Yishai Ofran, Jaroslav Cermak, Hartmut Döhner, Keshava Kumar, Barry S. Skikne, Qian Dong, Boris V. Afanasyev, Aida Botelho Sousa, Gail J. Roboz, Mehmet Turgut, Jun-Ho Jang, Gert J. Ossenkoppele, Dominik Selleslag, Chiara Frairia, Hervé Dombret, Pau Montesinos, Farhad Ravandi, Ignazia La Torre, Irwindeep Sandhu, Merih Kızıl Çakar, Andrew H. Wei, Hamid Sayar, G. Beltrami, Justyna Rybka, Kimmo Porkka |
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| Přispěvatelé: | Hematology laboratory, CCA - Cancer Treatment and quality of life |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Oncology
medicine.medical_specialty Chemotherapy Myeloid business.industry medicine.medical_treatment Myeloid leukemia Induction chemotherapy General Medicine 030204 cardiovascular system & hematology medicine.disease Oral Azacitidine 03 medical and health sciences Leukemia 0302 clinical medicine medicine.anatomical_structure Maintenance therapy hemic and lymphatic diseases Internal medicine medicine 030212 general & internal medicine business Survival analysis |
| Zdroj: | New England Journal of Medicine, 383(26), 2526-2537. Massachussetts Medical Society NEW ENGLAND JOURNAL OF MEDICINE r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname Wei, A H, Döhner, H, Pocock, C, Montesinos, P, Afanasyev, B, Dombret, H, Ravandi, F, Sayar, H, Jang, J-H, Porkka, K, Selleslag, D, Sandhu, I, Turgut, M, Giai, V, Ofran, Y, Çakar, M K, de Sousa, A B, Rybka, J, Frairia, C, Borin, L, Beltrami, G, Čermák, J, Ossenkoppele, G J, la Torre, I, Skikne, B, Kumar, K, Dong, Q, Beach, C L, the QUAZAR AML-001 Trial Investigators & Roboz, G J 2020, ' Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission ', New England Journal of Medicine, vol. 383, no. 26, pp. 2526-2537 . https://doi.org/10.1056/NEJMoa2004444 |
| ISSN: | 0028-4793 |
| DOI: | 10.1056/NEJMoa2004444 |
| Popis: | Background: Although induction chemotherapy results in remission in many older patients with acute myeloid leukemia (AML), relapse is common and overall survival is poor.\ud \ud Methods: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of the oral formulation of azacitidine (CC-486, a hypomethylating agent that is not bioequivalent to injectable azacitidine), as maintenance therapy in patients with AML who were in first remission after intensive chemotherapy. Patients who were 55 years of age or older, were in complete remission with or without complete blood count recovery, and were not candidates for hematopoietic stem-cell transplantation were randomly assigned to receive CC-486 (300 mg) or placebo once daily for 14 days per 28-day cycle. The primary end point was overall survival. Secondary end points included relapse-free survival and health-related quality of life.\ud \ud Results: A total of 472 patients underwent randomization; 238 were assigned to the CC-486 group and 234 were assigned to the placebo group. The median age was 68 years (range, 55 to 86). Median overall survival from the time of randomization was significantly longer with CC-486 than with placebo (24.7 months and 14.8 months, respectively; P |
| Databáze: | OpenAIRE |
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