Prospective Study of Cetuximab, Carboplatin, and Radiation Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Cancer Unfit for Cisplatin.

PURPOSE: To report on the outcomes of a novel treatment regimen for patients with locally advanced head and neck squamous cell carcinoma who were fit for curative treatment but not fit for cisplatin.

METHODS AND MATERIALS: Single-arm phase 1/2 study of previously untreated patients with biopsy-proven SCC of the oropharynx, larynx, or hypopharynx. The primary endpoint was feasibility of the regimen, defined as the proportion of patients successfully completing treatment. Secondary endpoints were locoregional control (LRC), failure-free survival (FFS), overall survival (OS), and treatment toxicities.

RESULTS: Sixty patients were included in the study. Their mean age was 66 years (range, 42-87 years); 28% of patients were >70 years. The median follow-up time was 4 years. Compliance with treatment was very high: feasibility was 55/60 (91.7%, 90% CI: 83.3%-96.7%), which satisfied the predefined criteria. The 4-year LRC was 82% (95% CI: 71-94), the FFS was 72% (95% CI: 60-85), and the OS was 77% (95% CI: 66-90). The cumulative incidences of first failure of any type at 4 years were 5.2% local, 1.8% local and distant, 8.5% regional, 1.7% regional and distant, 3.5% distant, and 7.7% death (any cause). The 4-year FFS in the patients aged ≤70 years and >70 years were 71% (95% CI: 58-88) and 73% (95% CI: 54-100), respectively (log-rank P=.801). Their 4-year OS was 79% (95% CI: 66-93) and 73% (95% CI: 53-100), respectively (log-rank P=.708). Significant late treatment toxicities were very few.

CONCLUSION: This treatment regimen was feasible and safe in this patient cohort unfit for cisplatin, 28% of whom were older than 70 years. Carboplatin-based and cetuximab-based chemoradiation regimens warrant further investigation in patients with a contraindication to cisplatin.