Postoperative Radiotherapy with Cetuximab Shows Promising Results for Head and Neck Cancer Patients

Recent findings from the Phase III NRG Oncology RTOG 0920 trial indicate that incorporating cetuximab into postoperative radiotherapy may enhance outcomes for patients with squamous cell carcinoma of the head and neck (SCCHN). This study primarily focused on assessing disease-free survival rates in individuals who had undergone surgery for this aggressive cancer type.

Conducted by NRG Oncology, the trial involved 577 patients diagnosed with SCCHN of the oral cavity, oropharynx, or larynx, all of whom exhibited one or more intermediate-risk factors necessitating postoperative radiotherapy but were not candidates for high-dose cisplatin chemotherapy. Notably, a significant proportion of the tumors (85%) demonstrated elevated expression of the epidermal growth factor receptor (EGFR).

Participants were randomly allocated to receive either intensity-modulated radiotherapy (IMRT) combined with weekly cetuximab or radiotherapy alone. While the primary aim of the study was to evaluate overall survival, secondary endpoints included disease-free survival and assessment of long-term toxicity associated with the treatments.

The results indicated that although the addition of cetuximab did not significantly improve overall survival at a median follow-up of 7.2 years, it did show a meaningful enhancement in disease-free survival. Specifically, the five-year disease-free survival rates were 71.7% for the combination therapy (C+RT) compared to 63.6% for radiotherapy alone (RT). The hazard ratio for disease-free survival was calculated at 0.75, with a p-value of 0.017, suggesting a statistically significant benefit from the combination treatment.

Moreover, the study reported no significant increase in long-term toxicity associated with the addition of cetuximab. Acute toxicity rates were higher in the combination group (70.3%) compared to radiotherapy alone (39.7%), but late toxicity rates were comparable between the two groups, with 33.2% for C+RT and 29.0% for RT. Importantly, no fatal toxicities were recorded in either treatment cohort.

These findings are particularly relevant given the poor prognosis associated with HPV-negative SCCHN, a patient demographic that historically experiences high rates of locoregional recurrence and mortality despite surgical interventions. The trial's lead researcher emphasized the potential of cetuximab to serve as a beneficial adjunct therapy in the postoperative setting for carefully selected patients who are not suitable candidates for cisplatin-based chemotherapy.

This study's outcomes, published in the Journal of Clinical Oncology, highlight the need for ongoing research to optimize treatment strategies for this challenging patient population. The encouraging results regarding disease-free survival reinforce the importance of exploring novel therapeutic combinations in the fight against head and neck cancers.