To evaluate the efficacy and safety of postoperative concurrent chemoradiotherapy (CRT) using weekly docetaxel in high-risk oral squamous cell carcinoma (OSCC) patients.
This is a prospective single-arm study from a single institute in XXX. Locally stage III-IV OSCC patients who received radical surgery with at least one high-risk feature were enrolled for the study. High-risk features evaluated included (a) pathologically confirmed positive or close margins in the primary site and/or extracapsular nodal extension; (b) histologic involvement of >= 2 regional lymph nodes; and (c) loco-regional recurrent OSCC (after initial surgery alone) treated with salvage surgery with curative intent. Docetaxel was administered at a dose of 20 mg/m concurrently with postoperative radiotherapy (total dose 60-66Gy). The primary outcome was 2-year disease-free survival (DFS). Secondary endpoints included 2-year loco-regional progress-free survival (LRFS), 2-year overall survival (OS), and toxicities.
From March 2016 to February 2018, 91 patients (59 males, 32 females) were recruited, with a median age of 59 years old (range 26-70). All patients were included in final analysis. 58 patients (63.7%) completed the 6 planned cycles of docetaxel and all patients completed postoperative radiotherapy. With a median follow-up of 24 months, the 2-year DFS and OS were 75.3% (95% CI, 65.7%-84.2%) and 82.4% (95% CI, 73.0%-89.6%), respectively. Patterns of failure were 13 local recurrences, 2 regional lymph nodes recurrences and 8 distant failures. 7 patients (7.7%) were recorded with grade 3 oral cavity mucositis. Two patients had Grade 3 hypersensitivity reaction. No other grade 3 or higher adverse events including hematological toxicities were observed.
The addition of low-dose weekly docetaxel with concurrent radiotherapy is a tolerable regimen with favorable DFS and OS in patients with high-risk, resected OSCC.

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