Postoperative chemotherapy with cisplatin and 5-fluorouracil in cancer of the oral cavity and the oropharynx--long-term results.

Adjuvant chemotherapy has not yet been proven to have a survival benefit for patients with head and neck cancer. Studies dealing with this topic have had several faults like mingling tumor localizations and treatment modalities. To re-examine the role of postoperative chemotherapy in oral cavity cancer, a single-center study was conducted with the attempt to have higher homogeneity. 122 patients with primary squamous cell carcinoma of the lip, the oral cavity and the oropharynx have been treated with 100 mg/m2 cisplatin bolus infusion and 120-h continuous infusion of 1000 mg/m2 5-fluorouracil following radical surgery; 99 patients completed all 3 cycles. The disease-free and overall survival are reported and compared to a control group of 161 patients with cancer of the lip, the oral cavity and oropharynx treated only with surgery, and a treatment-dependent prognostic index. After a median follow-up of 79 months (range 5-18 years), the current 5-year overall survival of the chemotherapy group was 67% and the 5-year disease-free survival was 57% while the respective data for the control group are 46% and 40%. This difference is statistically significant. The comparison with the prognostic index confirmed this result. The chemotherapy group suffered from fewer local and more neck relapses and had a much longer relapse latency (29 months versus 8 months). The toxicity of the chemotherapy regimen was tolerable. In a homogeneous population with resectable oral cavity and oropharyngeal cancer, postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil resulted in a high overall survival rate which was significantly better than in a comparable population treated only with surgery and better than the survival expectation calculated with the help of a prognostic index. A prospective randomized study of postoperative chemotherapy versus control, exclusively in patients with oral cancer, is warranted.

RCT Entities:   Population Interventions Outcomes