Abstract:

Objective To evaluate the efficacy and safety of nimotuzumab combined with definitive radiotherapy in the treatment of inoperable locally advanced oral and maxillofacial squamous cell carcinoma. Methods A total of 33 patients with inoperable locally advanced oral and maxillofacial squamous cell carcinoma admitted to the Ninth People's Hospital， Shanghai Jiao Tong University School of Medicine from March 2015 to December 2019 were retrospectively selected as the research objects. The treatment regimen was all targeted therapy （nimotuzumab） combined with definitive radiotherapy， with or without chemotherapy， and the efficacy and safety of the treatment were analyzed. The primary endpoints were optimal response and overall survival （OS）， and the secondary endpoints were optimal duration of response （DOR） and progression-free survival （PFS）. The survival curve was drawn using the Kaplan-Meier method， the survival rate of the patients was analyzed， and the related adverse reactions were counted. Results Of the 33 patients， there were 20 cases of complete remission （CR）， 5 cases of partial remission （PR）， 5 cases of stable disease （SD）， 2 cases of progressive disease （PD）， and 1 case could not be evaluated. The objective response rate was 75.8% （25/33）， and the disease control rate was 90.9% （30/33）. The mean OS of all cases was 54.5 months， and the 5-year OS rate was 57.0%. The mean DOR of the overall cases was 57.2 months， and the 5-year DOR rate was 64.4%. The mean PFS of the overall cases was 54.4 months， and the 5-year PFS rate was 59.8%. The 5-year OS rates of CR， PR and SD patients were 83.6%， 20.0% and 0 （χ²=20.07， P<0.001）， the 5-year DOR rates were 85.0%， 20.0% and 0 （χ²=16.89， P<0.001）， and the 5-year PFS rates were 84.0%， 20.0% and 0 （χ²=15.91， P<0.001）. The OS， DOR and PFS of patients with CR were significantly better than those of patients with PR and SD （all P<0.05）. The 5-year OS rates of patients with oropharyngeal cancer and oral cancer were 62.5% and 40.6% （χ²=1.67， P=0.197）， the 5-year DOR rates were 73.3% and 44.0% （χ²=1.34， P=0.247）， and the 5-year PFS rates were 68.8% and 40.9% （χ²=1.13， P=0.289）， with no statistically significant differences， but oropharyngeal cancer patients still showed a certain advantage. Common adverse reactions included oral mucositis and hematological toxicity， most of which were grade 1-2. Two （6.1%） patients had rash， and two （6.1%） patients had nausea and vomiting， which were considered to be related to nimotuzumab. All adverse reactions were relieved after symptomatic treatments. Conclusion For patients with locally advanced oral and maxillofacial squamous cell carcinoma who are not suitable for surgery， the choice of nimotuzumab combined with definitive radiotherapy has a relatively satisfactory efficacy and survival rate， with good safety and high clinical value.

Key words: Mouth neoplasms, Head and neck neoplasms, Neoplasms， squamous cell, Radiotherapy, Drug therapy