Abstract
Objectives
Remission rates and survival remain limited for the majority of elderly patients with
acute myeloid leukemia. Therefore, clinical trials with novel investigational strategies
could be considered for these patients. We sought to evaluate the influence of age
on outcome defined by survival and toxicity of 121 patients (range 28–82 years) with high-risk, relapsed/refractory acute myelogenous leukemia [ECOG PS 0–3]
who were enrolled on four consecutive phase I/II clinical trials between 1994 and
2008 conducted at two institutions.
Materials and methods
75/121 (62%) of the patients enrolled were ≥60 years old. Treatment included phase I topotecan and etoposide (23 patients); phase
I fludarabine, carboplatin, and topotecan (FCT) (27 patients); phase II FCT plus thalidomide
(39 patients); and phase I ispinesib (SB 994772) (32 patients). Outcome data including
CR (complete remission) rate, overall survival, and treatment related toxicities,
were analyzed according to prior treatment, disease characteristics, ECOG performance
status (PS), duration of first CR, and age.
Results
In multivariate analysis, survival and toxicities were similar between younger and
older patients. PS was the most significant determinant of overall survival (PS 0–1:
30-day survival 97.5% and 1 year survival 21% vs. PS 2–3: 79% and 9.5%, respectively) (p=0.029). Similarly, PS was the most important factor for development of serious non-hematologic
toxicities (p=0.034).
Conclusion
Our data suggest that elderly acute myeloid leukemia patients with good PS are appropriate
candidates for phase I/II clinical trials.
Keywords
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Article info
Publication history
Published online: March 25, 2011
Accepted:
February 23,
2011
Received in revised form:
January 14,
2011
Received:
October 20,
2010
Identification
Copyright
© 2011 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
