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.
Mediana wieku pacjentów wynosiła 67 lat, a guzy znajdowały się w jamie ustnej (47%), krtani (27%) i części ustnej gardła (13%). U 20% pacjentów występują przerzuty lokalne regionalne, u 27% przerzuty odległe, a u 53% oba. Piętnastu (50%) pacjentów otrzymało ≥ 2 zabiegi.
Spośród 28 ocenianych pacjentów u 11 (39%) wystąpiła odpowiedź nowotworowa, w tym u 3 (11%) odpowiedź całkowita i u 8 (29%) odpowiedź częściowa. U czternastu (50%) pacjentów choroba była stabilna, u 3 (11%) pacjentów nastąpiła progresja, a u 70% zmiany nowotworowe uległy zmniejszeniu.
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.