Effectiveness of incorporating cetuximab into docetaxel/cisplatin/fluorouracil induction chemotherapy and chemoradiotherapy for inoperable squamous cell carcinoma of the oral cavity: A phase II study

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Inoperable oral cavity squamous cell carcinoma (SCC) is a highly invasive disease associated with the extensive destruction of locoregional tissues and a dismal prognosis. Management strategies for these patients are limited.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This study was a single arm, prospective, open‐label phase II trial. A regimen consisting of cetuximab‐docetaxel, cisplatin, and fluorouracil (C‐TPF) followed by bio‐chemoradiotherapy (bio‐CRT) with cisplatin and cetuximab was administered to patients who responded to induction chemotherapy. The objective response rate to C‐TPF was the primary endpoint.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Forty‐three patients were enrolled in this study. The objective response rate of C‐TPF was 88.4%; 88.9% (32/36) of the responders completed the full bio‐CRT course, and the objective response rate of bio‐CRT was 64.7%. The most common grade 3/4 adverse events for induction chemotherapy were leucopenia (32.6%) and febrile neutropenia (14.0%). The 1‐year progression‐free survival (PFS) and overall survival (OS) rates were 43% and 68%, respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>C‐TPF is an effective and tolerable induction chemotherapy regimen for inoperable oral cavity SCC.</jats:p></jats:sec>