Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab‐based concurrent bioradiotherapy in high‐risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial

Abstract

Background

The prognosis of advanced oral squamous cell carcinoma is poor. We investigated the effect of cetuximab‐based sequential therapy as a primary treatment.

Methods

Forty‐seven treatment‐naive patients with advanced tumors originating from the oral cavity or oropharynx were enrolled. Neoadjuvant cetuximab, paclitaxel, and cisplatin were administered, followed by cetuximab‐based radiotherapy. Immunohistochemical staining was applied to study the tissues.

Results

The best overall response rate was 70.2%, including 4 patients with a complete response and 29 with a partial response. The median progression‐free and overall survival rates were 10.3 and 15.2 months, respectively. Patients with more than 50% tumor reduction with neoadjuvant therapy had better survival outcomes. Twenty‐two patients had severe adverse events with mostly dermatological complications. Of the 16 patients who received operations, 9 had increased PD‐L1 staining compared to pretreatment biopsy in the post hoc study.

Conclusion

The regimen was effective in selected patients. Increased PD‐L1 suggested altered tumor features.

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