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
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.
For more information, talk to your physician, visit www.mdanderson.org, or call askMDAnderson at 877-632-6789.
articles in OncoLog, June 2012 issue:
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