Adding Palbociclib to Cetuximab in Platinum-Resistant Head and Neck Cancer
Posted: Tuesday, August 20, 2019
Adding the CDK4/6 inhibitor palbociclib to cetuximab resulted in a nonsignificant trend toward greater overall survival yet no apparent benefit in progression-free survival in patients with platinum-resistant head and neck squamous cell carcinoma, according to the phase II PALATINUS trial. The research was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 6013) by Douglas Adkins, MD, of Washington University in Saint Louis, and colleagues.
“Palbociclib plus cetuximab resulted in a trend of prolongation of median overall survival compared with cetuximab,” wrote the authors.
The double-blind trial included 125 patients with platinum-resistant, cetuximab-naive, human papillomavirus–unrelated head and neck squamous cell carcinoma. Patients were randomly assigned to treatment with cetuximab plus either palbociclib (65 patients) or a placebo (60 patients). The authors stratified patients by performance status and previous immunotherapy.
In terms of overall survival, there was a nonstatistically significant trend: the median overall survival was 9.7 months in the palbociclib arm and 7.8 months in the placebo arm. Stratified by performance status, the hazard ratio was 0.82. The median follow-up for overall survival was 15.9 months. The median progression-free survival was 3.9 months in the palbociclib arm and 4.6 months in the placebo arm. With patients stratified by performance status, the hazard ratio was 1.00.
Hematologic adverse events were more common in patients who received palbociclib than in those who did not. After their treatment in the trial, 11 patients (9%) received immunotherapy.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.