Patients with cutaneous T-cell lymphoma (CTCL) who are treated with romidepsin may have longer response periods with every other week dosing, or even once per month dosing, than with the standard dosing regimen, according to researchers at the Northwestern University’s Feinberg School of Medicine.
The study “Durable Responses With Maintenance Dose-Sparing Regimens of Romidepsin in Cutaneous T-Cell Lymphoma,” presents a retrospective analysis of romidepsin real-world usage in CTLC patients.
Originally published in the April issue of JAMA Oncology, the study was recently supported in a June editorial submitted by Dr. Susan E. Bates, a faculty member in drug development and epigenetic therapies at Columbia University Medical Center, and Dr. Larisa J. Geskin, associate professor of dermatology and director of the Comprehensive Skin Cancer Center at Columbia University Medical Center.
“Now, in a retrospective review, of medical records of CTCL patients who received romidespin between 2010 and 2015, we get a glimpse of romidespin real world use,” Bates and Gedskin wrote.
CTLC, T-cell lymphoma of the skin only, has long been managed as a chronic disease and patients are treated for life. Although the standard romidepsin schedule for CTLC is infusion on days 1, 8, and 15 of a 28-day cycle, the drug’s long-term use in a real world setting using a dose-sparing regimen had not been studied.
Researchers led by Dr. Joan Guitart, professor of dermatology and pathology at the Feinberg School of Medicine, retrospectively examined 47 patients with CTLC from a previous study who responded to a dose-sparing romidepsin regimen: 23 had mycosis fungoides, 15 had Sézary syndrome, and nine had unspecified CTLC.
Among the study patients, the researchers found an overall response rate of 53%, including seven complete remissions and 18 partial remissions. However, none of the nine patients with CTLC achieved a durable response.
Among the 38 patients with classical mycosis fungoides or Sázary syndrome (types of cutaneous T-cell lymphoma) an overall response rate of 61% was observed — which highly exceeded that observed in the Phase 2 standard-dosing trials that led to romidepsin’s FDA approval.
Seventeen patients who remained on treatment for more than 6 months were considered long-responders. Among them, three received monthly dosing regimen and nine received every other week dose-sparing regimen.
Over the median 15 month treatment period, three patients achieved complete remission and six achieved partial remission.
But because the study was a retrospective, considerably small and un retrospective, the results could not be compared to studies that led to romidepsin’s FDA approval in 2009; they could however, serve to compare dose sparing regimens to standard therapy, Guitart said.
Bates and Geskin agreed. Considering the complexity of weekly 4-hour intravenous doses, the uptake of he uptake of romidepsin after its approval by the FDA remained uncertain.
“Some may take exception to the retrospective, observational nature of this report. But I would note that a 47-patient single-institution observational study in a rare disease over 5 years likely represents the majority of patients who could be candidates for this therapy—without much selection,” Bates and Geskin wrote. “. . . but here in the work of (M. Estela) Martinez-Escala and colleagues, we see successful translation of clinical trial results to real-world experience.”