高危唾液腺肿瘤患者术后同期放化疗前瞻性Ⅱ期临床试验研究  

Prospective phaseⅡstudy of postoperative concurrent chemoradiotherapy for patients with high-risk malignant salivary gland tumors

作　　者：王鑫[1] 窦圣金 李烿烿[2] 吴思成 陈刚[1] 张霖[2] 杨雯君[2] 朱国培[2] Wang Xin;Dou Shengjin;Li Rongrong;Wu Sicheng;Chen Gang;Zhang Lin;Yang Wenjun;Zhu Guopei(Department of Radiation Oncology,Huangpu Branch,Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Department of Oral and Maxillofacial-Head Neck Oncology,Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Biostatistics Office of Clinical Research Center,Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China)

机构地区：[1]上海交通大学医学院附属第九人民医院黄浦分院放疗科,200011 [2]上海交通大学医学院附属第九人民医院口腔颌面头颈肿瘤科,200011 [3]上海交通大学医学院附属第九人民医院临床研究中心生物统计研究室,200011

出　　处：《中华放射肿瘤学杂志》2020年第3期166-170,共5页Chinese Journal of Radiation Oncology

基　　金：上海市卫计委临床项目(201640158)。

摘　　要：目的评估术后辅助同期放化疗对具有高危预后因素的唾液腺肿瘤患者的疗效和安全性。方法入组2016-2018年间上海第九人民医院口腔颌面头颈肿瘤科收治的中度或高度恶性病理分级且伴有局部晚期Ⅲ/ⅣA期±切缘阳性/近切缘的唾液腺肿瘤术后患者52例。男35例,女17例,平均年龄55.5岁(21~73岁)。患者术后调强放疗和同期化疗。唾液腺腺癌患者同期化疗采用TP方案,淋巴上皮癌、鳞状细胞癌患者采用顺铂方案。结果47例患者完成全部2周期同期化疗,5例患者完成1周期同期化疗。中位随访期为15.7个月(3.2~34.8个月),2年无瘤生存、总生存率分别为74%、98%。3例区域淋巴结复发,6例远处转移。3级放射性口腔黏膜炎30例,3级放射性皮肤损伤5例,3-4级中性粒细胞减少3例。DFS与术后辅助同期放化疗用药周期数呈正相关(P=0.006)。结论高危唾液腺肿瘤术后患者同期放化疗可获得较高的2年无瘤生存、总生存且可耐受的,长期结果仍需随机对照临床研究进一步证实。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 stageⅢ/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.GradeⅢoral mucositis was observed in 30 patients.GradeⅢdermatitis occurred in 5 cases.Only one patient experienced Grade IV neutropenia,and 2 patients developed GradeⅢneutropenia.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.

关 键 词：高危唾液腺肿瘤 术后辅助 同期放化疗 前瞻性研究 

分 类 号：R73[医药卫生—肿瘤]