Abstract
6575 Background: Relapsed/refractory acute leukemia patients (pts) have a poor outcome and should be considered for enrollment on clinical trials. Elderly (≥ 60 yr) acute leukemia patients often are excluded from phase I/II cytotoxic agent re-induction chemotherapy trials due to concerns for treatment-related toxicity. Methods: Pts with relapsed/refractory acute leukemia who were enrolled on three consecutive phase I/II clinical trials at University Hospitals of Cleveland were evaluated for outcome data including complete response (CR), serious adverse events, and overall survival (OS). Outcome data was compared for pts age ≥ 60 yr versus < 60 yr. Pts with ECOG Performance Status (PS) 0 to 3 were eligible and there was no age limitation. Results: Between 1994 and 11/2005, 96 acute leukemia pts median age 60 yr (range 19–78) were enrolled: 29 pts received phase I topotecan-etoposide; 31 pts received phase I fludarabine, carboplatin, and topotecan (FCT); and 37 pts received phase II FCT plus thalidomide. In univariate analysis, PS at therapy initiation, mean # prior treatments, and disease status at time of treatment were not statistically different between older and younger pts ( Table ). Using Kaplan-Meier method, early treatment-related mortality and OS were similar in pts age ≥ 60 yr compared to pts < 60 yr ( Table ). Mean # ≥ grade 3 toxicities and CR also were similar in both groups ( Table ). In univariate (p = 0.001) and multivariate (p = 0.0004) analyses by Cox modeling, pts PS 0–1 had better OS than PS 2–3 (PS 0–1: 30-day survival 98% and 1 yr survival 24% versus PS 2–3: 30-day survival 81% and 1 yr survival 6%). Conclusions: Poor PS is an important negative predictor of outcomes in relapsed/refractory acute leukemia pts. Advanced age should not exclude pts from cytotoxic re-induction chemotherapy trials. [Table: see text] No significant financial relationships to disclose.
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