Prospective phase II study of postoperative concurrent chemoradiotherapy for patients with high-risk malignant salivary gland tumors

Abstract

Objective To assess the efficacy and safety of post operative adjuvant concurrent chemoradiotherapy for patients with high-risk salivary gland tumors (SGT). Methods Fifty-two patients with moderate or high malignant pathological stage complicated with locally advanced stage Ⅲ/ⅣA±positive margin/close margin admitted to Shanghai Ninth People′s Hospital from 2016 to 2018 were enrolled in this study. Among them, 35 patients were male and 17 female with a median age of 55.5 years old (range: 21-73 years old). All 52 patients were treated with intensity-modulated radiotherapy and concurrent chemotherapy. Patients with adeno carcinoma of the salivary gland receives concurrent chemotherapy with TP regimen. Patients with lympho epithelial cancer and squamous cell carcinoma were treated with cisplatin regimen. Results Forty-seven patients (90%) completed two cycles of concurrent chemotherapy, and five patients (10%) completed one cycle of concurrent chemotherapy. The median follow-up time was 15.7 months (3.2-34.8 months). The 2-year disease-free survival (DFS) and overall survival (OS) rates were 74% and 98%. Three patients experienced regional lymph recurrence and 6 cases had distant metastasis. Grade Ⅲ oral mucositis was observed in 30 patients. Grade Ⅲ dermatitis occurred in 5 cases. Only one patient experienced Grade IV neutropenia, and 2 patients developed Grade Ⅲ neutropenia. DFS was positively correlated with the cycle of postoperative adjuvant concurrent chemotherapy (P=0.006). Conclusions Patients with high-risk SGT can obtain higher 2-year DFS and OS rates and tolerable adverse events after postoperative concurrent chemoradiotherapy. Nevertheless, the long-term outcomes remain to be validated by randomized controlled clinical trials. Key words: High-risk salivary gland tumor; Postoperative adjuvant; Concurrent chemoradiotherapy; Prospective study