Palbociclib in Patients With Head and Neck Cancer and Other Tumors With
Publication/Presentation Date
10-1-2024
Abstract
PURPOSE: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and targetable genomic alterations. Two cohorts of patients with cyclin-dependent kinase inhibitor 2A (
METHODS: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16+ weeks duration. For the HNC cohort, Simon's two-stage design with a null DC rate of 15% versus 35% (power = 0.85; α = .10) was used. For the HP cohort, the null hypothesis of a DC rate of 15% was rejected if the lower limit of a one-sided 90% CI was >15%. Secondary end points included OR, safety, progression-free survival, overall survival, duration of response, and duration of SD.
RESULTS: Seventy patients with HNC (N = 28) or HP cancers (N = 42) were treated with palbociclib. For the HNC cohort, DC and OR rates were 40% (one-sided 90% CI, 27 to 100) and 4% (95% CI,18), respectively. The null hypothesis was rejected (
CONCLUSION: Palbociclib met prespecified criteria to declare a signal of activity in patients with HNC with
Volume
8
First Page
2400477
Last Page
2400477
ISSN
2473-4284
Published In/Presented At
Worden, F. P., Pisick, E., Rothe, M., Mangat, P. K., Garrett-Mayer, E., Khalil, M. F., Carrizosa, D. R., Bauman, J. R., Leidner, R. S., Duvivier, H. L., Fu, S., Park, M. S., Yost, K. J., Calfa, C. J., Marr, A. S., Balmanoukian, A. S., Behl, D., Cannon, T. L., Nabell, L., Powell, S. F., … Schilsky, R. L. (2024). Palbociclib in Patients With Head and Neck Cancer and Other Tumors With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO precision oncology, 8, e2400477. https://doi.org/10.1200/PO-24-00477
Disciplines
Medicine and Health Sciences
PubMedID
39413339
Department(s)
Department of Medicine, Lehigh Valley Topper Cancer Institute
Document Type
Article