Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study.
In: ISSN: 0140-6736, 2012
academicJournal
Zugriff:
International audience ; BACKGROUND: The results of the addition of gemtuzumab ozogamicin, an anti-CD33 antibody conjugate, to the standard treatment for patients with acute myeloid leukaemia in phase 3 trials were contradictory. We investigated whether the addition of low fractionated-dose gemtuzumab ozogamicin to standard front-line chemotherapy would improve the outcome of patients with this leukaemia without causing excessive toxicity. METHODS: In a phase 3, open-label study, undertaken in 26 haematology centres in France, patients aged 50-70 years with previously untreated de novo acute myeloid leukaemia were randomly assigned with a computer-generated sequence in a 1:1 ratio with block sizes of four to standard treatment (control group) with or without five doses of intravenous gemtuzumab ozogamicin (3 mg/m(2) on days 1, 4, and 7 during induction and day 1 of each of the two consolidation chemotherapy courses). The primary endpoint was event-free survival (EFS). Secondary endpoints were relapse-free (RFS), overall survival (OS), and safety. Analysis was by intention to treat. This study is registered with EudraCT, number 2007-002933-36. FINDINGS: 280 patients were randomly assigned to the control (n=140) and gemtuzumab ozogamicin groups (n=140), and 139 patients were analysed in each group. Complete response with or without incomplete platelet recovery to induction was 104 (75%) in the control group and 113 (81%) in the gemtuzumab ozogamicin group (odds ratio 1*46, 95% CI 0*20-2*59; p=0*25). At 2 years, EFS was estimated as 17*1% (10*8-27*1) in the control group versus 40*8% (32*8-50*8) in the gemtuzumab ozogamicin group (hazard ratio 0*58, 0*43-0*78; p=0*0003), OS 41*9% (33*1-53*1) versus 53*2% (44*6-63*5), respectively (0*69, 0*49-0*98; p=0*0368), and RFS 22*7% (14*5-35*7) versus 50*3% (41*0-61*6), respectively (0*52, 0*36-0*75; p=0*0003). Haematological toxicity, particularly persistent thrombocytopenia, was more common in the gemtuzumab ozogamicin group than in the control group (22 [16%] vs 4 [3%]; ...
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Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study.
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| Autor/in / Beteiligte Person: | Castaigne, Sylvie ; Pautas, Cécile ; Terré, Christine ; Raffoux, Emmanuel ; Bordessoule, Dominique ; Bastie, Jean-Noel ; Legrand, Ollivier ; Thomas, Xavier ; Turlure, Pascal ; Reman, Oumedaly ; de Revel, Thierry ; Gastaud, Lauris ; de Gunzburg, Noémie ; Contentin, Nathalie ; Henry, Estelle ; Marolleau, Jean-Pierre ; Aljijakli, Ahmad ; Rousselot, Philippe ; Fenaux, Pierre ; Preudhomme, Claude ; Chevret, Sylvie ; Dombret, Hervé ; Renseigné, Non ; Centre Hospitalier de Versailles André Mignot (CHV) ; Contrôle de la Réponse Immune B et des Lymphoproliférations (CRIBL) ; Université de Limoges (UNILIM)-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Centre National de la Recherche Scientifique (CNRS) ; Service d'Hématologie clinique et thérapie cellulaire CHU Limoges ; Limoges, CHU ; Service d'Hématologie Clinique (CHU de Dijon) ; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon) ; Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL) ; Centre Léon Bérard Lyon -Université Claude Bernard Lyon 1 (UCBL) ; Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS) ; Hôpital Edouard Herriot CHU -, HCL ; Hospices Civils de Lyon (HCL) ; Laboratoire de Biologie Moléculaire et Cellulaire du Cancer Luxembourg (LBMCC) ; Hôpital Kirchberg Luxembourg ; Amiens-Picardie, CHU ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) ; Service d'Hématologie Cellulaire Lille ; Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille) ; Institut de recherche sur le cancer ; Institut National de la Santé et de la Recherche Médicale (INSERM) ; Biostatistique et épidemiologie clinique ; Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Lymphocyte et cancer ; IFR105-Institut National de la Santé et de la Recherche Médicale (INSERM) ; ANR-10-IBHU-0002,SLI,Institut Saint-Louis(2010) |
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| Zeitschrift: | ISSN: 0140-6736, 2012 |
| Veröffentlichung: | HAL CCSD ; Elsevier, 2012 |
| Medientyp: | academicJournal |
| DOI: | 10.1016/S0140-6736(12)60485-1 |
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