医学
锁骨上窝
粘膜炎
鼻咽癌
头颈部癌
内科学
临床终点
胃肠病学
癌症
放射治疗
癌
人口
临床研究阶段
原发性肿瘤
肿瘤科
毒性
外科
转移
临床试验
乳腺癌
环境卫生
作者
Shengjin Dou,Rongrong Li,Lin Zhang,Zhuoying Wang,Li Xie,Chenping Zhang,Guopei Zhu
摘要
Abstract Objective Controversy still exists regarding the volume of radiation for head and neck cancer of unknown primary (HNCUP). Theoretically, elective mucosal irradiation (EMI) should achieve a balance between survival and toxicity. This prospective study was conducted to evaluate the long‐term benefit of EMI in Chinese HNCUP patients. Methods A phase II, single‐arm trial was performed at two centers in China. HNCUP patients with pathologically confirmed metastatic squamous cell carcinoma or poorly differentiated carcinoma were enrolled. Patients with metastatic lymph nodes limited to level IV and/or the supraclavicular fossa were excluded. The EMI approach was specifically customized to Chinese patients by differentiating HNCUP as putative nasopharyngeal carcinoma (NPC) or non‐putative NPC. The primary endpoint was 3‐year mucosal recurrence‐free survival (MRFS). Results A total of 48 patients were enrolled between 02/02/2010 and 08/01/2018; 46 patients were analyzed, including 24 putative NPC and 22 non‐putative NPC patients. No primary recurrence was observed during a median follow‐up period of 70 months, and only 1 patient experienced out of field recurrence in the contralateral neck. The 3‐year MRFS was 90.6% (95%CI: 76.4%‐96.4%). The 5‐year MRFS, regional‐recurrence free survival (RRFS) and overall survival (OS) were 90.6% (95%CI: 76.4%‐96.4%), 86.0% (95%CI: 71.1%‐93.7%), and 90.6% (95%CI: 76.4%‐96.4%), respectively. No grade 4 acute or late toxicities occurred, and the most frequent grade 3 acute toxicity was oral mucositis (45.7%). Conclusion To the best of our knowledge, this is the first prospective study to evaluate the long‐term outcomes of EMI in Chinese HNCUP patients. Excellent MRFS and OS rates were observed. Further randomized studies are warranted.
科研通智能强力驱动
Strongly Powered by AbleSci AI