Palbociclib in Patients With Head and Neck Cancer and Other Tumors With
Publication Title
JCO Precis Oncol
Document Type
Article
Publication Date
10-1-2024
Keywords
Humans; Pyridines; Piperazines; Female; Male; Middle Aged; Head and Neck Neoplasms; Cyclin-Dependent Kinase Inhibitor p16; Aged; Adult; Registries; Aged, 80 and over; Mutation; oregon; portland; washington; swedish cancer
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
Area of Special Interest
Neurosciences (Brain & Spine)
Area of Special Interest
Cancer
Specialty/Research Institute
Neurosciences
Specialty/Research Institute
Oncology
Specialty/Research Institute
Pharmacy
DOI
10.1200/PO-24-00477.
