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J Clin Oncol. 2016 Mar 20;34(9):972-9. doi: 10.1200/JCO.2015.64.0060. Epub 2016 Jan 25.

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.

Author information

1
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; Frédéric Baron, Centre Hospitalier Universitaire, Liège, Belgium; Petra Muus and Theo de Witte, Radboudumc, Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands. sergio.amadori@ptvonline.it.
2
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; Frédéric Baron, Centre Hospitalier Universitaire, Liège, Belgium; Petra Muus and Theo de Witte, Radboudumc, Nijmegen; and Roel Willemze, University Medical Center, Leiden, the Netherlands.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00091234.

PMID:
26811524
DOI:
10.1200/JCO.2015.64.0060
[Indexed for MEDLINE]
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