Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study.

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.