More adverse effects seen for high dose in patients with higher-risk myelodysplastic syndrome
FRIDAY, Jan. 27 (HealthDay News) -- Low and high doses of clofarabine have comparable clinical activity for the treatment of patients with higher-risk myelodysplastic syndrome (MDS), according to a study published in the Feb. 1 issue of Cancer.
Stefan Faderl, M.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and colleagues conducted a randomized study to evaluate the activity and safety of two doses (15 versus 30 mg/m² daily for five days) of intravenous clofarabine in patients with higher-risk MDS. A cohort of 58 participants (median age, 68 years), including 15 patients (28 percent) with secondary MDS and 35 patients (60 percent) who had previously received DNA methyltransferase (DNMT) inhibitors, were adaptively randomized between the two dose groups.
The researchers found that the overall response rate (ORR) was 36 percent, including 26 percent of patients with complete remission (CR). The ORR was 41 percent at 15 mg/m² and 29 percent at 30 mg/m². Patients who had failed DNMT inhibitors had lower response rates (ORR, 17 percent; CR rate, 14 percent). The eight-week mortality rate was 19 percent, with a median survival of 7.4, 13.4, and 21.7 months for all patients, responders, and complete responders, respectively. For patients randomized to 30 mg/m² of clofarabine, some of the adverse events, including hepatic and renal, were more severe (grade >2). Frequent complications included myelosuppression and infectious complications.
"Both the lower and higher doses of clofarabine have comparable clinical activity, but the lower dose appeared less toxic," the authors write.
Several authors disclosed financial ties to Genzyme, which manufactures clofarabine.
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