Reduced-Dose Romidepsin May Prolong Response in Cutaneous Lymphoma

The long-term use of romidepsin in a dose-sparing regimen to treat cutaneous T-cell lymphoma may be a useful strategy to try to prolong disease response.

The long-term use of romidepsin in a dose-sparing regimen to treat cutaneous T-cell lymphoma (CTCL) may be a useful strategy to try to prolong disease response, according to the results of a study in JAMA Oncology.

Romidepsin was approved by the US Food and Drug Administration in 2009 to treat relapsed or refractory CTCL. Clinical trials of the drug established a standard schedule of infusions on days 1, 8, and 15 of a 28-day cycle. However, long-term use of the drug past 6 cycles, and the use of dose-sparing regimens have not yet been reported.

“Results obtained from this case series suggest that patients initially benefiting from a standard dosing schedule of romidepsin may benefit by transitioning to a reduced dose-sparing regimen, which allows for maintaining response, tolerability, and convenience,” wrote M. Estela Martinez-Escala, MD, of the Northwestern University Feinberg School of Medicine in Chicago, and colleagues.

In this review, Martinez-Escala and colleagues evaluated real-world experiences with the long-term use of romidepsin. They looked at medical records taken from 47 patients with CTCL, including 23 with mycosis fungoides and 15 with Sézary syndrome, and nine patients had CTCL not otherwise specified.

Of the nine patients with CTCL not otherwise specified, none achieved a durable response on romidepsin. The median duration of treatment for the other 38 patients was 5 months. The median duration of response was 13 months. Seventeen of the 25 patients who had a response had responses of at least 6 months in duration after treatment initiation.

Nine of the 17 patients were assigned a dose-sparing regimen. Six of these patients switched from the standard regimen to dosing every other week; three of the patients were switched to monthly dosing. The median time to reduction in dosing was 7.4 months.

The median time to treatment failure among patients whose treatment was discontinued was 4 months. Of patients switching to a dose-sparing regimen, three achieved a complete remission and six achieved partial remission.

“The median time to treatment failure of chemotherapies for CTCL is only 3 months,” the researchers wrote. “Our novel approach presents an alternative to the standard regimens, offering the possibility of prolonged responses with an improvement in quality of life for patients with mycosis fungoides and Sézary syndrome.”

“One could argue in favor of discontinuing romidepsin therapy after achievement of a robust response, with the plan to re-treat on progression during the active surveillance period, as compared with continuing therapy with the dose reduction (ie, maintenance) strategy,” the researchers wrote. “A randomized trial comparing these approaches could be conducted.”