In Brief

From OncoLog, June 2012, Vol. 57, No. 6

In Brief

Panobinostat Elicits Durable Response in Hodgkin Lymphoma

The experimental drug panobinostat can elicit durable disease responses in Hodgkin lymphoma (HL) patients who have relapsed disease or disease that is refractory to autologous stem-cell transplantation, a multicenter, international phase II study has found.

The prospective study, which was conducted in part at The University of Texas MD Anderson Cancer Center, enrolled 129 HL patients who had progressive disease despite having received high-dose autologous stem-cell transplantation. The patients received 40 mg of panobinostat 3 times per week in a 21-day cycle. Therapy was stopped when patients experienced progressive disease or intolerable toxicity, began new therapy, or withdrew from the study.

Panobinostat was also stopped if the investigator believed it to no longer benefit the patient. Panobinostat reduced tumor size in 96 patients (74%). Based on the investigators’ assessment of the patients’ computed tomography or magnetic resonance imaging studies, 30 patients’ tumors had a partial response to panobinostat, and five patients’ tumors had a complete response to panobinostat, for an objective response rate of 27%. In addition, panobinostat stabilized HL in 71 patients (55%). The median time to response was 2.3 months (range, 0.9–11.8 months). The median durations of response and progression-free survival were 6.9 months and 6.1 months, respectively. At the end of the study, the 1-year overall survival rate was estimated to be 78%.

Panobinostat was generally well tolerated. The most common nonhematological adverse events were grade 1 or 2 and included diarrhea in 81 patients (63%), nausea in 76 patients (59%), vomiting in 38 patients (29%), and fatigue in 37 patients (29%). The most common hematological adverse event was grade 3 or 4 thrombocytopenia in 102 patients (79%), which was usually manageable by adjusting the panobinostat dose or dosing schedule or by temporarily stopping panobinostat.

An exploratory biomarker analysis of 117 patients revealed that the mean levels of the biomarker thymus and activation–regulated chemokine (TARC) were reduced by 28%, 22%, and 10% in patients who had a complete response, partial response, or stable disease, respectively; however, patients with progressive disease did not have a change in TARC levels. Further analysis revealed that patients with a lower-than-median reduction of TARC were at greater risk of disease progression than were patients with a higher-than-median reduction of TARC.

The study’s report was published online (ahead of print) on April 30 by the Journal of Clinical Oncology.

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