AML therapeutic options in recent years for patients over 65 years of age, who generally are not candidates for intensive chemotherapy, have been quite limited, mainly with low intensity chemotherapy, hypomethylating agents and supportive care.
Since January 2014 we have followed the therapeutic protocol consisting in induction chemotherapy with FLUGA chemotherapy scheme according to the PETHEMA group, 2 cycles in the patients of ≤ 75 years and one cycle for the older age, followed by maintenance with decitabine (20 mg / m2 5 days every 4 weeks until progression).
A total of 33 patients with AML with age ≥65 years have recieved the treatment, 17 men and 16 women, with a median age of 77 years (65–91), 19 with primary AML, 2 related to previous chemotherapy, 3 secondary Myeloproliferative Chronic Syndrome and 9 to Myelodysplastic Syndrome. Characteristics of the patients at diagnosis are shown in the Table 1.
Table 1. Data at diagnosis
Twelve patients received 2 cycles of FLUGA scheme and 21 patients received only one cycle. Twenty-one patients went into the maintenance phase with decitabine with a median of administered cycles of 6.5 (range 1–31). 13 patients (39%) reached complete remission. Early mortality at 30 days was 13.3% (4 patients). During evolution, 10 patients (29%) required hospital admission due to infectious process.
The median overall survival (OS) was 6 months (95% CI 1–11 months), with a probability of OS at 6 and 12 months of 51% and 29% respectively. There were no significant differences in OS between patients with primary AML versus secondary AML or treatment-related (median 6 versus 3 months, Log-Rank p = 0.73) neither between patients of less or more than 75 years (median of 6 and 5 months respectively: p = 0.93). OS was significantly higher in patients who reached complete remission compared to those who did not (median of 2 and 18 months respectively, p <0.001).
The induction with FLUGA followed by Decitabine maintenance therapy until disease progression is a generally well tolerated treatment, with low initial mortality rate and low number of hospital admissions due to any infection. The percentage of complete responses is reached in a third of the patients and, as is usually observed in elderly subjects, survival is limited to only a third of patients after a year of diagnosis.