Background: A prospective clinical trial of combination neoadjuvant chemotherapy, transoral robotic surgery (TORS), and customized adjuvant therapy for patients with locally advanced oropharyngeal cancer was conducted. Methods: Between July 2009 and October 2016, 31 patients were enrolled in this clinical trial. Results: The primary lesions were located in the tonsils of 27 patients and in the base of the tongue of 4 patients. Of the 31 patients, 16 (51.6%) were classified as T3 and 15 patients (48.4%) as T4a. Three patients (9.7%) had stage 3 disease, and 28 (90.3%) had stage 4 disease. The 5-year overall survival rate was 78.7%; the 5-year disease-specific survival rate was 85%; and the 5-year disease-free survival rate was 80.8%. At the final follow-up visit, 26 patients were alive with no evidence of disease, and 1 was alive with disease. Four patients died during the study: two of tumor-node-metastasis (TNM)-related disease and two of another condition. All the patients tolerated an oral diet at an average of 7.4 days postoperatively. At the subjective swallowing evaluation using the Functional Outcome Swallowing Scale score, 83.9% of the patients exhibited favorable outcomes. No patient was permanently dependent on a feeding tube. All the patients breathed and phonated in the absence of a permanent tracheotomy at the final follow-up evaluation. Conclusions: The treatment strategy in this study afforded good oncologic and functional outcomes for patients with locally advanced oropharyngeal cancer. Although future large-scale multicenter studies with longer follow-up periods are needed, this study showed that neoadjuvant chemotherapy combined with TORS is useful for treating advanced oropharyngeal cancer.
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