Head and neck cancer — including cancers of the oral cavity, oropharynx, hypopharynx, and larynx — is the 4th leading cancer among Taiwanese men. Despite the progressions in the treatment of advanced oral squamous cell carcinoma (OSCC), its prognosis remain poor. Cetuximab (Erbitux®) is an epidermal growth factor receptor (EGFR) inhibitor currently used for the treatment of head and neck cancer. Dr. Kwang‐Yu Chang from the National Institute of Cancer Research initiated a single-arm phase II clinical trial in which a cetuximab-based sequential regimen was applied as the treatment for late-stage OSCC to investigate the response and the survival benefit of the regimen.
Dr. Chang and team recruited 47 treatment-naive patients with advanced tumors originating from the oral cavity or oropharynx. Patients received neoadjuvant cetuximab, paclitaxel, and cisplatin administrations, followed by cetuximab-based radiotherapy. Immunohistochemical staining was then applied to study the tissues. The clinical trial reported a best overall response rate of 70.2%, which included 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. 22 patients had severe adverse events with mostly dermatological complications. Of the 16 patients with evaluable post-treatment tumor specimens, 9 had increased programmed death-ligand 1 (PD-L1) staining compared to pretreatment biopsy in the post hoc study.
The sequential therapy showed a modest response rate and survival outcomes, suggesting the regimen was effective in selected patients. In addition, the increased PD-L1 proposed altered tumor features by the treatment. This finding has been published in Head and Neck (2019 Jun;41(6):1703-1712). .
Citation: Yen, CJ; Tsou, HH; Hsieh, CY; Chu, CY; Chiu, CF; Chen, CC; Tsao, CJ; Tsai, KY; Tsai, ST; Chang, JY; Chang, KY. 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. Head and Neck. 2019 Jun;41(6):1703-1712.