Treatment of acute promyelocytic leukemia (APL) has evolved over recent years, resulting in a cure rate of 75-80%. However, the prognosis of older patients with APL remains poorer as compared to young adults because of substantial morbidity of either induction or consolidation therapy. We describe therapeutic results in a series of 34 consecutive APL patients aged over 60 years, with particular emphasis on those patients managed outside of clinical trials because of comorbidities at diagnosis. All patients were programmed to receive the GIMEMA AIDA protocol, based on all transretinoic acid as induction followed by chemotherapy as consolidation. The median age was 70 years. Twenty-three patients (68%) received the protocol, while 11 (32%) were given a personalized approach. The median age was 69 years for patients on protocol as opposed to 75 years for the remaining ones (p=0.02). Six patients (18%) died within two days of diagnosis; among these, only one was on the AIDA protocol. Overall, complete response (CR) was achieved in 68% of cases; the CR rate was 74% for patients on the protocol as opposed to 54 % for those not. The most frequent cause of death was cerebral hemorrhage. Patients accrued into the GIMEMA AIDA protocol achieved longer survival (median not reached vs. 10 months, p=0.03). In conclusion, our data demonstrate that at least 30% of older APL patients are not eligible to accrual in multicenter trials; furthermore, in this subset, the possibility of early death is substantial. However, when CR is achieved, a personalized consolidation approach can be adopted with the possibility of achieving long-term disease control.

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