Phase II Study of Clofarabine for Older Patients with Treatment-Naïve AML
Slides from a presentation at ASH 2008, transcribed comments from a recent presentation by Hagop M Kantarjian, MD (10/17/09) and recent interviews with Gail J Roboz, MD (10/6/09) and Steven D Gore, MD (10/8/09) below
Presentations discussed in this issue:
Erba HP et al. 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. Blood 2008;112:558. Abstract
Kantarjian M et al. Classic II: Updated remission duration and survival results of single agent clofarabine in previously untreated older adult patients with acute myelogenous leukemia and at least one unfavorable baseline prognostic factor. Haematologica 2009;94;Abstract 0835.
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HAGOP M KANTARJIAN, MD: In older patients, we are hoping for something good with clofarabine, an adenosine analog like CDA and fludarabine, but it’s completely different in the sense that it doesn’t work in lymphoid tumors, except for pediatric leukemias, but it has a major effect in acute myeloid leukemia (AML) and in myelodysplastic syndromes.
We developed this Phase II study three years ago and enrolled older patients with AML with adverse features, and we demonstrated that the drug is associated with a response rate of 40 percent that persists across combinations of adverse factors, with a low mortality of under 10 percent at four weeks. What we see in this study is that once the patients have a response, it is durable beyond a year, and the median survival is approximately nine months with the one-year survival rate at approximately 45 percent. The data are encouraging, and we are proceeding with randomized trials with this drug.
GAIL J ROBOZ, MD: This is an interesting paper for clinicians because fairly few drugs out there have a meaningful complete remission rate in AML. Physicians need to be aware of these data, because clofarabine is a single-agent drug with a relatively high complete remission rate and a favorable toxicity profile. Currently, a randomized cooperative group trial of clofarabine with cytarabine versus cytarabine alone is being conducted and physicians need to try to accrue patients to it.
STEVEN D GORE, MD: In this study, 112 elderly patients with AML received single-agent clofarabine, resulting in an overall response rate of 46 percent, with complete responses of 38 percent. There is no question that this drug warrants further investigation.
Dr Kantarjian is Chairman and Professor of the Leukemia Department at The University of Texas MD Anderson Cancer Center in Houston, Texas.
Dr Roboz is Associate Professor of Medicine and Director of the Leukemia Program at Weill Medical College of Cornell University at NewYork-Presbyterian Hospital in New York, New York.
Dr Gore is Professor of Oncology at Johns Hopkins University in Baltimore, Maryland.