Open AccessReport of a Phase II Study of Clofarabine and Cytarabine in De Novo and Relapsed and Refractory AML Patients and in Selected Elderly Patients at High Risk for Anthracycline Toxicity
Author(s) -
Agura Edward,
Cooper Barry,
Holmes Houston,
Vance Estil,
Berryman Robert Brian,
Maisel Christopher,
Li Sandy,
Saracino Giovanna,
TadicOvcina Mirjana,
Fay Joseph
Publication year - 2011
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2010-0220
Subject(s) - clofarabine , medicine , cytarabine , refractory (planetary science) , transplantation , anthracycline , gastroenterology , myeloid leukemia , hematopoietic stem cell transplantation , surgery , toxicity , cancer , physics , astrobiology , breast cancer
Purpose. To determine the efficacy and safety of clofarabine and cytarabine (Ara‐C) in adult patients with relapsed or refractory acute myeloid leukemia (AML) and in elderly patients with untreated AML and heart disease. Patients and Methods. Patients with relapsed/refractory AML and older patients for whom there was a concern over toxicity from additional anthracyclines received 5 days of clofarabine, 40 mg/m 2 per day i.v. over 1 hour, followed 4 hours later by Ara‐C, 1,000 mg/m 2 per day i.v. over 2 hours. Results. Thirty patients were enrolled. The median age was 67 years (range, 38–82 years) and 18 (60%) had received at least one prior therapy. Eleven (37%) patients had a history of cardiovascular disease and were considered to be at high risk for anthracycline toxicity. High‐risk cytogenetic abnormalities were present in 14 (47%) patients. The overall response rate (complete remission [CR] plus partial remission) was 53%, including a CR in 14 patients (47%). Responses were observed in all cytogenetic risk groups and in patients who had received up to five prior therapies. The median disease‐free survival interval was 9.5 months. The 30‐day mortality rate was 20% (de novo AML, 8%; relapsed/refractory AML, 28%). Of the 14 patients achieving a CR, half were able to proceed to curative hematopoietic stem cell transplantation. Conclusions. Clofarabine in combination with Ara‐C is effective in both untreated and previously treated patients with AML. In addition, it represents a useful remission induction strategy to serve as a bridge to transplantation in older patients with AML.