NEW YORK (Reuters Health) – About one in four patients with peripheral T-cell lymphoma (PTCL) who do not respond to or relapse after systemic therapy are likely to have an objective response to romidepsin, a potent histone deacetylase inhibitor, according to the results of an open-label, phase II trial.
The study, which led to the US Food and Drug Administration’s approval of the drug for refractory or relapsed PTCL in 2011, is being published in the Journal of Clinical Oncology online January 23.
“Romidepsin provides a much needed treatment option in this indication with few effective therapies,” the authors comment.
Dr. Bertrand Coiffier, at the Centre Hospitalier Lyon-Sud, France, and colleagues explain that PTCL is a collection of rare disorders arising from clonal proliferation of mature T-cells. It usually affects adults and has a poor prognosis. Conventional chemotherapy protocols frequently fail, but histone deacetylase inhibitors have promising antitumor activity.
The team conducted a trial with 130 patients with histologically confirmed PTCL who had had between one and eight unsuccessful systemic treatments. They received romidepsin as a 4-hour infusion on days 1, 8 and 15 every 28 days for up to six cycles.
An objective response was documented in 33 (25%) of the patients, which included 19 (15%) patients with a complete response, the investigators report.
Similar responses were seen in all the common PTCL subtypes, and there were no meaningful differences in response rates based on the number or type of prior therapies, or prior autologous stem-cell transplantation, the report indicates.
Adverse effects included nausea and vomiting, infections, fatigue and thrombocytopenia, but most adverse events were mild to moderate. ECG abnormalities occurred in eight patients, with prolonged QT interval in 4 of those cases.
The discontinuation rate because of treatment-related adverse effects was 10%, Dr. Coiffier and colleagues report.
Overall, they conclude, “Results warrant further investigation of romidepsin in the first-line setting and in combination with CHOP or other experimental agents.”
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