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

Sergio Amadori, Stefan Suciu, Dominik Selleslag, Franco Aversa, Gianluca Gaidano, Maurizio Musso, Luciana Annino, Adriano Venditti, Maria Teresa Voso, Carla Mazzone, Domenico Magro, Paolo De Fabritiis, Petra Muus, Giuliana Alimena, Marco Mancini, Anne Hagemeijer, Francesca Paoloni, Marco Vignetti, Paola Fazi, Liv MeertSafaa Mahmoud Ramadan, Roel Willemze, Theo de Witte, Frédéric Baron

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)972-9
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number9
DOIs
Publication statusPublished - Mar 20 2016

Keywords

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Aminoglycosides
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Female
  • Humans
  • Hydroxyurea
  • Leukemia, Myeloid, Acute
  • Male
  • Middle Aged
  • Clinical Trial, Phase III
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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