PMID- 26811524
OWN - NLM
STAT- MEDLINE
DCOM- 20160715
LR  - 20220207
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 34
IP  - 9
DP  - 2016 Mar 20
TI  - Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly 
      Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results 
      of the Randomized Phase III EORTC-GIMEMA AML-19 Trial.
PG  - 972-9
LID - 10.1200/JCO.2015.64.0060 [doi]
AB  - PURPOSE: To compare single-agent gemtuzumab ozogamicin (GO) with best supportive 
      care (BSC) including hydroxyurea as first-line therapy in older patients with 
      acute myeloid leukemia unsuitable for intensive chemotherapy. PATIENTS AND 
      METHODS: In this trial, patients at least 61 years old were centrally randomized 
      (1:1) to receive either a single induction course of GO (6 mg/m(2) on day 1 and 3 
      mg/m(2) on day 8) or BSC. Patients who did not progress after GO induction could 
      receive up to eight monthly infusions of the immunoconjugate at 2 mg/m(2). 
      Randomization was stratified by age, WHO performance score, CD33 expression 
      status, and center. The primary end point was overall survival (OS) by 
      intention-to-treat analysis. RESULTS: A total of 237 patients were randomly 
      assigned (118 to GO and 119 to BSC). The median OS was 4.9 months (95% CI, 4.2 to 
      6.8 months) in the GO group and 3.6 months (95% CI, 2.6 to 4.2 months) in the BSC 
      group (hazard ratio, 0.69; 95% CI, 0.53 to 0.90; P = .005); the 1-year OS rate 
      was 24.3% with GO and 9.7% with BSC. The OS benefit with GO was consistent across 
      most subgroups, and was especially apparent in patients with high CD33 expression 
      status, in those with favorable/intermediate cytogenetic risk profile, and in 
      women. Overall, complete remission (CR [complete remission] + CRi [CR with 
      incomplete recovery of peripheral blood counts]) occurred in 30 of 111 (27%) GO 
      recipients. The rates of serious adverse events (AEs) were similar in the two 
      groups, and no excess mortality from AEs was observed with GO. CONCLUSION: 
      First-line monotherapy with low-dose GO, as compared with BSC, significantly 
      improved OS in older patients with acute myeloid leukemia who were ineligible for 
      intensive chemotherapy. No unexpected AEs were identified and toxicity was 
      manageable.
CI  - (c) 2016 by American Society of Clinical Oncology.
FAU - Amadori, Sergio
AU  - Amadori S
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands. 
      sergio.amadori@ptvonline.it.
FAU - Suciu, Stefan
AU  - Suciu S
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Selleslag, Dominik
AU  - Selleslag D
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Aversa, Franco
AU  - Aversa F
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Gaidano, Gianluca
AU  - Gaidano G
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Musso, Maurizio
AU  - Musso M
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Annino, Luciana
AU  - Annino L
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Venditti, Adriano
AU  - Venditti A
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Voso, Maria Teresa
AU  - Voso MT
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Mazzone, Carla
AU  - Mazzone C
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Magro, Domenico
AU  - Magro D
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - De Fabritiis, Paolo
AU  - De Fabritiis P
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Muus, Petra
AU  - Muus P
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Alimena, Giuliana
AU  - Alimena G
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Mancini, Marco
AU  - Mancini M
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Hagemeijer, Anne
AU  - Hagemeijer A
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Paoloni, Francesca
AU  - Paoloni F
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Vignetti, Marco
AU  - Vignetti M
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Fazi, Paola
AU  - Fazi P
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Meert, Liv
AU  - Meert L
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Ramadan, Safaa Mahmoud
AU  - Ramadan SM
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Willemze, Roel
AU  - Willemze R
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - de Witte, Theo
AU  - de Witte T
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
FAU - Baron, Frederic
AU  - Baron F
AD  - Sergio Amadori, Adriano Venditti, and Maria Teresa Voso, Tor Vergata University; 
      Luciana Annino, San Giovanni Addolorata Hospital; Paolo De Fabritiis, St Eugenio 
      Hospital; Giuliana Alimena and Marco Mancini, Sapienza University; Francesca 
      Paoloni, Marco Vignetti, and Paola Fazi, GIMEMA Foundation, Roma; Franco Aversa, 
      University Hospital, Parma; Gainluca Gaidano, University of Eastern Piedmont, 
      Novara; Maurizio Musso, La Maddalena Clinic, Palermo; Carla Mazzone, Annunziata 
      Hospital, Cosenza; Domenico Magro, Pugliese-Ciaccio Hospital, Catanzaro; Safaa 
      Mahmoud Ramadan, European Institute of Oncology, Milano, Italy; Stefan Suciu and 
      Liv Meert, EORTC Headquarters, Brussels; Dominik Selleslag, AZ St Jan, Brugge; 
      Anne Hagemeijer, KULeuven, Leuven; Frederic Baron, Centre Hospitalier 
      Universitaire, Liege, Belgium; Petra Muus and Theo de Witte, Radboudumc, 
      Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT00091234
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160125
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Aminoglycosides)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 93NS566KF7 (Gemtuzumab)
RN  - X6Q56QN5QC (Hydroxyurea)
SB  - IM
EIN - J Clin Oncol. 2022 Feb 10;40(5):525. PMID: 35130465
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Aminoglycosides/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Female
MH  - Gemtuzumab
MH  - Humans
MH  - Hydroxyurea/therapeutic use
MH  - Leukemia, Myeloid, Acute/*drug therapy
MH  - Male
MH  - Middle Aged
EDAT- 2016/01/27 06:00
MHDA- 2016/07/16 06:00
CRDT- 2016/01/27 06:00
PHST- 2016/01/27 06:00 [entrez]
PHST- 2016/01/27 06:00 [pubmed]
PHST- 2016/07/16 06:00 [medline]
AID - JCO.2015.64.0060 [pii]
AID - 10.1200/JCO.2015.64.0060 [doi]
PST - ppublish
SO  - J Clin Oncol. 2016 Mar 20;34(9):972-9. doi: 10.1200/JCO.2015.64.0060. Epub 2016 
      Jan 25.