Arsenic trioxide improves event-free and over-all survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710.

Summary of "Arsenic trioxide improves event-free and over-all survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710."

Arsenic trioxide(As(2)0(3)) is a highly effective treatment for patients with relapsed acute promyelocytic leukemia(APL); its role as consolidation treatment for patients in first remission has not been defined. We randomized 481 patients (age>/=15) with untreated APL to either a standard induction regimen of tretinoin, cytarabine and daunorubicin, followed by two courses of consolidation therapy with tretinoin plus daunorubicin, or to the same induction and consolidation regimen plus two 25-day courses of (As(2)0(3)) consolidation immediately following induction. Following consolidation, patients were randomly assigned to one year of maintenance therapy with either tretinoin alone or in combination with methotrexate and mercaptopurine. Ninety percent of patients on each arm achieved remission and were eligible to receive their assigned consolidation therapy. Event-free survival, the primary endpoint, was significantly better for patients assigned to receive (As(2)0(3)) consolidation, 80% compared to 63% at three years (stratified-log rank test, p<0.0001). Survival, a secondary endpoint, was better in the (As(2)0(3)) arm, 86% compared to 81% at three years (p=0.059). Disease-free survival, a secondary endpoint, was significantly better in the (As(2)0(3)) arm, 90% compared to 70% at three years (p<0.0001). The addition of (As(2)0(3)) consolidation to standard induction and consolidation therapy significantly improves event-free and disease-free survival in adults with newly diagnosed APL. This trial was registered at http://clinicaltrial.gov (NCT00003934).

Affiliation

Cancer and Leukemia Group B (CALGB), Chicago, IL, United States;

Journal Details

This article was published in the following journal.

Name: Blood
ISSN: 1528-0020
Pages:

Links

• PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20705755
• DOI: http://dx.doi.org/10.1182/blood-2010-02-269621