Back to Search
Start Over
All trans retinoic acid in combination with intermediate-dose cytarabine and idarubicin in patients with relapsed or refractory non promyelocytic acute myeloid leukemia: a phase II randomized trial
- Source :
- The hematology journal : the official journal of the European Haematology Association. 3(1)
- Publication Year :
- 2001
-
Abstract
- Introduction: All trans retinoic acid has shown a remarkable eAectiveness in acute promyelocytic leukemia. These results have encouraged studies of treatment with ATRA in other acute myeloid leukemia subtypes. Patients and methods: In order to evaluate toxicity and antileukemic eAcacy of all ATRA in patients with relapsed or refractory non promyelocytic AML, 95 patients (median age, 58 years; range, 20 to 80 years), with unclassified AML according to the FAB classification or secondary AML at diagnosis, or refractory or relapsing AML, received induction therapy with Idarubicin, 10 mg/m 2 /day, for 3 days and cytarabine, 1000 mg/m 2 /12 h, for 6 days, alone or combined, on a randomized basis, with ATRA, 45 mg/m 2 /day, from day 1 to complete remission. Patients in CR received maintenance therapy with 6 monthly courses combining Ida, 10 mg/m 2 /day, intravenously, on day 1 with Ara-C100 mg/m 2 /day, subcutaneously, from day 1 to day 5. Results: Results were evaluated after one induction course. Overall 54 patients (57%, 26 with ATRA and 28 without ATRA) achieved CR including five patients treated at time of initial diagnosis, seven previously resistant, 38 in first relapse and four in further relapse. Thirty patients (31%) had resistant disease and 11 (12%) died from toxicity. Median time for neutrophil recovery to 0.5610 9 /l and platelets to 20610 9 /l was 31 and 21 days respectively. Severe toxicity (WHO grade 53) included infections (37%), diarrhea (9%), bleeding (3%), vomiting (16%), hyperbilirubinemia (5%), mucositis (6%) and hypercreatininemia (2%). No ATRA syndrome was noted in the ATRA arm. Median overall survival for the entire cohort was 6.3 months and median disease-free survival was 4.7 months. There were no statistical diAerences in terms of CR, DFS, and OS between the two arms. Conclusion: We conclude that ATRA in combination with Ida and Ara-C can be administered safely to high-risk AML patients. However, in this setting, ATRA did not oAer any advantage when compared to chemotherapy alone. The Hematology Journal (2002) 3, 49‐55. DOI: 10.1038/sj/thj/6200141
- Subjects :
- Acute promyelocytic leukemia
Adult
Male
medicine.medical_specialty
medicine.medical_treatment
Salvage therapy
Tretinoin
Gastroenterology
Maintenance therapy
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Mucositis
Idarubicin
Humans
neoplasms
Aged
Aged, 80 and over
Salvage Therapy
Chemotherapy
business.industry
Remission Induction
Cytarabine
Myeloid leukemia
Hematology
Middle Aged
medicine.disease
Survival Analysis
Surgery
Treatment Outcome
Therapeutic Equivalency
Leukemia, Myeloid
Acute Disease
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 14664860
- Volume :
- 3
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- The hematology journal : the official journal of the European Haematology Association
- Accession number :
- edsair.doi.dedup.....acab4913f5278135bd8057bcea440707