Photo by Larry Young
SAN FRANCISCO—The oral histone deacetylase inhibitor chidamide can elicit responses in patients with relapsed or refractory cutaneous T-cell Lymphoma (CTCL), a new study suggests.
Chidamide has already demonstrated efficacy against relapsed or refractory peripheral T-cell lymphoma and has been approved for this indication in China.
Now, results of a phase 2 trial suggest chidamide might be a feasible treatment option for relapsed or refractory CTCL as well.
Yuankai Shi, MD, PhD, of the Chinese Academy of Medical Science & Peking Union Medical College in Beijing, China, discussed this trial at the 8th Annual T-cell Lymphoma Forum. The trial is sponsored by Chipscreen Biosciences Ltd.
He presented results observed in 50 patients with relapsed/refractory CTCL. They had a median age of 47 (range, 26-75), and half were male. Most patients had stage II disease (44%), 20% percent had stage III, and 18% each had stage I and IV. The median time from diagnosis was 2 years.
Patients were randomized to receive chidamide at 30 mg twice a week for 2 weeks out of a 3-week cycle (n=12), 4 weeks out of a 6-week cycle (n=13), or 30 mg twice a week without a drug-free holiday (n=25).
The objective response rate was 32% for the entire cohort, 33% for the 3-week cycle arm, 23% for the 6-week cycle arm, and 36% for the successive dosing arm.
There was 1 complete response, and it occurred in the successive dosing arm. There were 15 partial responses—4 in the 3-week arm, 3 in the 6-week arm, and 9 in the successive dosing arm.
The median duration of response was 92 days overall (range, 78-106), 50 days in the 3-week arm (range, 26-130), 92 days in the 6-week arm (range, 84-99), and 169 days in the successive dosing arm (range, 58-279).
The median progression-free survival was 85 days overall (range, 78-92), 84 days in the 3-week arm (range, 43-126), 81 days in the 6-week arm (range, 39-222), and 88 days in the successive dosing arm (range, 58-261).
Dr Shi noted that the major toxicities associated with chidamide were hematologic and gastrointestinal in nature, and they were controllable.
The incidence of adverse events (AEs) was 83% overall, 92% in the 3-week arm, 85% in the 6-week arm, and 77% in the successive dosing arm. The incidence of grade 3 or higher AEs was 23%, 23%, 38%, and 15%, respectively.
The most common AEs were thrombocytopenia (33%, 39%, 23%, and 35%, respectively), leucopenia (29%, 54%, 31%, and 15%, respectively), fatigue (17%, 23%, 23%, and 12%, respectively), nausea (13%, 23%, 8%, and 12%, respectively), diarrhea (10%, 8%, 8%, and 12%, respectively), fever (8%, 0%, 15%, and 8%, respectively), and anemia (8%, 8%, 15%, and 4%, respectively).
There were 2 serious AEs. One patient in the 3-week arm was hospitalized for fever and lung infection, and 1 patient in the successive dosing arm was hospitalized for hyperglycemia.
Dr Shi said these results suggest chidamide is effective and tolerable for patients with relapsed/refractory CTCL. And, based on the overall profiles of the 3 dosing regimens, successive dosing of chidamide at 30 mg twice a week is recommended.
