NEW YORK (Reuters Health) – Patients who have undergone prior systemic therapies for cutaneous T-cell lymphoma may respond well to treatment with romidepsin, a potent inhibitor of histone deacetylases, according to the results of a multicenter, open-label phase II study.
Dr. Sean Whittaker of St. Thomas Hospital, London, UK and colleagues report the findings in the Journal of Clinical Oncology published online.
The team studied 96 patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sezary syndrome, most with advanced disease (stage IIB or higher) and all with a history of one or more prior systemic treatments.
“Patients received romidepsin as an intravenous infusion at a dose of 14 mg/m² on days 1, 8, and 15 every 28 days,” the investigators explain. “Response was determined by a composite assessment of total tumor burden including cutaneous disease, lymph node involvement, and blood (Sezary cells).”
While 35 of the patients completed at least six cycles of treatment, the other 61 discontinued before this.
The objective response rate was 34%; that is, 27 patients had a partial response and 6 had a complete response. Response to romidepsin was seen in all stages of disease, including advanced disease. Specifically, 26 of 68 patients with IIB or higher stage disease responded, including five complete responses.
The median duration of response was 15 months.
The researchers point out that 28 of 65 patients with severe pruritus had a meaningful improvement — even some patients who did not have an objective disease response.
Most adverse events were mild to moderate in severity, most often GI related. Fourteen patients discontinued treatment because of drug-related adverse events such as fatigue, prolonged QT, or pyrexia.
“Romidepsin has significant and sustainable single-agent activity (including improvement in pruritus) and an acceptable safety profile, making it an important therapeutic option for treatment refractory CTCL,” Dr. Whittaker and colleagues conclude.
The findings from the current study and one other led to approval by the Food and Drug Administration last year of romidepsin for patients with CTCL.
“Despite this new therapy, CTCL remains a chronic illness that, in advanced stages, requires fairly constant therapy. By combining romidepsin with other drugs, regimens that result in even more significant and durable responses may be identified,” the team adds.
Final Results From a Multicenter, International, Pivotal Study of Romidepsin in Refractory Cutaneous T-Cell Lymphoma
J Clin Oncol 2010;28.