According to the results announced at the 2018 ASCO annual meeting, the CDK4/6 inhibitors pabociclib (Ibrance) and cetuximab (Erbitux) combined treatment of platinum-resistant and HPV-independent recurrent/metastatic head and neck The overall response rate for patients with squamous cell carcinoma (HNSCC) is 39%. In a non-randomized, 3-arm, phase II trial (NCT02101034), the results of a group of studies have a median progression-free survival (PFS) of 5.4 months, a median overall survival (OS) of 9.5 months, and a 1-year OS The rate is 35%.
In this study, 30 patients with HNSCC unrelated to HPV progressed after platinum-based therapy for relapsed/metastatic disease and participated in the trial. Patients who had previously received cetuximab for relapse and HPV-related oropharyngeal cancer were not eligible. Patients received palbociclib from day 1 to day 21, 125 mg daily; cetuximab, with a starting dose of 400 mg/m 2 and then 250 mg/m 2 per week for a period of 28 days until the disease progressed or withdrew the study. The researchers performed imaging examinations before treatment and after every 2 cycles.
Медиана возраста пациентов составила 67 лет, локализация опухоли – ротовая полость (47%), гортань (27%) и ротоглотка (13%). У 20% пациентов имеются местные регионарные метастазы, у 27% — отдаленные метастазы, у 53% — и то, и другое. Пятнадцать (50%) пациентов получили ≥ 2 процедур.
Из 28 оцениваемых пациентов у 11 (39%) были ответы опухоли, включая 3 (11%) полных ответа и 8 (29%) частичных ответов. У четырнадцати (50%) пациентов было стабильное заболевание, у 3 (11%) пациентов наблюдалось прогрессирование, а у 70% наблюдалось уменьшение опухолевых поражений.
Researcher Dr. Adkins said that Palbociclib and cetuximab have strong antitumor activity in platinum-resistant HPV-independent head and neck cancer, and biologically targeted therapy for HPV-independent head and neck cancer is an effective treatment strategy. . We look forward to the better results of the follow-up research.