NEW YORK (Reuters Health) Aug 11 - Azacitidine effectively treats acute myeloid leukemia (AML) in nearly a third of patients, researchers from Italy report in the July 14th online Cancer.
"In elderly (>70 yrs) patients with AML, the main goal of therapy is to prolong survival, maintaining a good quality of life (e.g., no mucositis, ability to perform outpatient therapy, etc)," Dr. Luca Maurillo from Tor Vergata Foundation Polyclinic, Rome, told Reuters Health in an email. "Demethylating agents seem to be promising drugs for this purpose."
Dr. Maurillo and colleagues investigated the efficacy of azacitidine in a retrospective analysis of 82 patients with AML who received azacitidine between June 2005 and December 2009.
Thirty-five patients were treatment na�ve and 47 patients had received other chemotherapy before they were treated with azacitidine.
The overall response rate was 32%, including 12 complete remissions (15%), 4 complete remissions with incomplete blood count recovery (5%), and 10 partial remissions (12%).
The response rate was higher among previously untreated patients (17/35, 48%) than among pretreated patients (9/47, 19%).
The median overall survival from start of azacitidine treatment was 9 months in previously untreated patients and 7 months in previously treated patients. At a median follow-up of 12 months, the projected overall survival was 35% in the untreated group and 18% in the pretreated group.
The lack of prior treatment and white blood cell counts below 10 billion/L were significantly associated with a response to azacitidine, whereas white blood cell count was the only factor significantly associated with overall survival duration.
Just over a quarter of the patients (22/82, 27%) experienced grade 3 or 4 myelosuppression, 9 patients (11%) developed febrile neutropenia, and 10 patients (12%) developed infection. Eleven patients (13%), including 4 untreated and 7 pretreated, died during treatment.
"It would be certainly interesting to compare in a randomized trial azacitidine with supportive care (mainly in patients >70 years) or other chemotherapy drugs to confirm the real benefit of the drug," Dr. Maurillo said. "In this regard, there is an ongoing international trial that will clarify this open question."
"The therapeutic results of classic chemotherapy in elderly patients with AML are strongly limited by toxic deaths," Dr. Maurillo added. "New drugs less toxic than chemo, such as cloretazine, are being tested with results comparable to demethylating agents."
Azacitidine isn't currently FDA-approved for use in AML, but formal clinical trials are underway. Azacitidine is FDA-approved for several myelodysplastic syndrome (MDS) subtypes, including refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
"In elderly (>70 yrs) patients with AML, the main goal of therapy is to prolong survival, maintaining a good quality of life (e.g., no mucositis, ability to perform outpatient therapy, etc)," Dr. Luca Maurillo from Tor Vergata Foundation Polyclinic, Rome, told Reuters Health in an email. "Demethylating agents seem to be promising drugs for this purpose."
Dr. Maurillo and colleagues investigated the efficacy of azacitidine in a retrospective analysis of 82 patients with AML who received azacitidine between June 2005 and December 2009.
Thirty-five patients were treatment na�ve and 47 patients had received other chemotherapy before they were treated with azacitidine.
The overall response rate was 32%, including 12 complete remissions (15%), 4 complete remissions with incomplete blood count recovery (5%), and 10 partial remissions (12%).
The response rate was higher among previously untreated patients (17/35, 48%) than among pretreated patients (9/47, 19%).
The median overall survival from start of azacitidine treatment was 9 months in previously untreated patients and 7 months in previously treated patients. At a median follow-up of 12 months, the projected overall survival was 35% in the untreated group and 18% in the pretreated group.
The lack of prior treatment and white blood cell counts below 10 billion/L were significantly associated with a response to azacitidine, whereas white blood cell count was the only factor significantly associated with overall survival duration.
Just over a quarter of the patients (22/82, 27%) experienced grade 3 or 4 myelosuppression, 9 patients (11%) developed febrile neutropenia, and 10 patients (12%) developed infection. Eleven patients (13%), including 4 untreated and 7 pretreated, died during treatment.
"It would be certainly interesting to compare in a randomized trial azacitidine with supportive care (mainly in patients >70 years) or other chemotherapy drugs to confirm the real benefit of the drug," Dr. Maurillo said. "In this regard, there is an ongoing international trial that will clarify this open question."
"The therapeutic results of classic chemotherapy in elderly patients with AML are strongly limited by toxic deaths," Dr. Maurillo added. "New drugs less toxic than chemo, such as cloretazine, are being tested with results comparable to demethylating agents."
Azacitidine isn't currently FDA-approved for use in AML, but formal clinical trials are underway. Azacitidine is FDA-approved for several myelodysplastic syndrome (MDS) subtypes, including refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
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