Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 7025
© 2008 American Society of Clinical Oncology

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Abstract

Phase II study of single agent clofarabine in previously untreated older adult patients with acute myelogenous leukemia (AML) unlikely to benefit from standard induction chemotherapy

University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; University of Texas M. D. Anderson Cancer Center, Houston, TX; Penn State Hershey Medical Center, Hershey, PA; Emory University School of Medicine, Atlanta, GA; Cancer Care Centers of Texas, San Antonio, TX; Oregon Health and Science University Center, Portland, OR; Mount Sinai School of Medicine, New York, NY; Genzyme Oncology, San Antonio, TX; Genzyme Oncology, Cambridge, MA

7025

Background: Studies have identified a population of older AML patients unlikely to benefit from standard combination induction therapy ("7+3") based on adverse prognostic factors such as advanced age, poor performance status (PS), antecedent hematologic disorder (AHD), or intermediate/unfavorable risk karyotype. This study assessed the efficacy and safety of single agent clofarabine (CLO) in this population. Methods: Single arm, Phase II, open-label, 2-stage study; planned total enrollment of 109 patients. Eligible untreated AML patients included adults 60 years with 1 adverse prognostic factor: 70 years, AHD, PS 2, and/or intermediate/unfavorable risk karyotype. CLO given on days 1–5 as a 1-hr IV infusion: 30 mg/m² during induction and 20 mg/m² during re-induction/consolidation (6 cycles maximum). Primary endpoint was overall remission rate (ORR = CR + CRp). Preliminary Results: Enrollment completed with 116 patients. As of Aug 2007, safety data were available for 54 patients; efficacy data for 40 patients. Median age was 71 years. Baseline prognostic factors: 65% 70 years, 37% with AHD (13% yet unreported), 70% with intermediate/unfavorable risk karyotype (30% yet unreported), and 19% with PS 2. 30-day all-cause mortality was 13%. Drug related adverse events in >20% of patients: nausea (41%), vomiting (28%), diarrhea (26%), febrile neutropenia (24%), and rash (20%). Most treatment-related events were Grades 1–2. Treatment emergent Grade 3 febrile neutropenia occurred in 30% of patients. Treatment emergent Grade 4 neutropenia was reported in 33% of patients with baseline ANC values available. The ORR was 43% (95% CI: 27.0%, 59.1%): 40% CR (95% CI: 24.9%, 56.7%) plus 3% CRp (95% CI 0.1%, 13.2%). ORR by prognostic factor: 58% for unfavorable risk karyotype, 44% for intermediate risk karyotype; 44% for AHD; 32% for age 70, 67% for age <70; and 14% for PS 2. Conclusions: These interim data indicate that single agent CLO is active and well-tolerated in treatment-naïve, older AML patients with 1 adverse prognostic factor, especially unfavorable risk karyotype and/or AHD. Safety and efficacy results for all patients will be presented.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genzyme Genzyme Genzyme Genzyme Genzyme Corporation

Abstract presentation from the 2008 ASCO Annual Meeting