Nimotuzumab plus chemotherapy with docetaxel, cisplatin, 5-fluorouracil for locally advanced head and neck squamous cell carcinoma: A clinical study

Background: A clinical study was conducted to determine the efficacy of nimotuzumab combined with docetaxel, cisplatin, and 5-fluorouracil (TPF) for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) after surgery and conformal radiotherapy. Methods: Thirty-one HNSCC patients received three courses of chemotherapy every 21 days, at a dose of 75 mg/m(2) of docetaxel and cisplatin on day 1 and 750 mg/m(2) of 5-fluorouracil on days 1u5 followed by 200 mg/m(2)/week of nimotuzumab on week 1u2 (day 6u21). Results: After sequential therapy, complete and partial responses were observed in 10 (32.3%) and 17 (54.8%) patients, respectively. The overall response rate was 87.1%. A progression-free survival of 71.2% (95% confidence interval [CI] 51.6%u93.7%) and an overall survival of 78.3% (95% CI 58.9%u89.5%) were achieved at 2(nd) year. The most common Grade 3u4 toxicities during the complete treatment were lymphopenia (25.8%), neutropenia (22.6%), anemia (12.9%), and diarrhea (16%). In addition, no rash and treatment-related death occurred during this study. Conclusions: Nimotuzumab in combination with TPF has been well tolerated as a treatment program for locally advanced HNSCC.