Survival results of neoadjuvant chemotherapy for advanced squamous cell carcinoma of the head and neck

Background: We carried out an open, randomized multi-center clinical trial for advanced head and neck cancer between April 1991 and December 1992. In this report, we update the results and analyze the 5-year survival results. Methods: Thirty-two patients with previously untreated stage III and IV res ectable squamous cell carcinoma of the oral cavity and pharynx were entered into the study. The PEM regimen consisted of cisplatin 60 mg/m(2) 2 h infu sion on day 1, etoposide 40 mg/m(2) 1 h infusion on days 1, 2 and 3 and mit omycin-C 7 mg/m(2) i.v. bolus on day 1. Results: Among the 32 patients entered into this trial, eight were disquali fied from the analysis. Of the remaining 24 patients, 13 were given neoadju vant chemotherapy (NAC) and 11 underwent surgery alone. Among the 13 patien ts who received NAG, four achieved a complete response (31%) and three a pa rtial response (23%), with an overall response rate of 54%. Myelosuppressio n was a major side effect. Thrombocytopenia and anemia were dose-limiting t oxicities. Other adverse reactions, including mucositis, were all mild and transient. The overall 5-year survival after NAC and without NAC were 83 an d 62%, respectively. The survival difference was not statistically signific ant (p = 0.33), Conclusions: NAC does not appear to play a role in the treatment of cancer of the oral cavity and pharynx with our PEM regimen. However, the degree of toxicity was limited in our trial and therefore attempts to increase the d osage and/or revise the administration schedule for cancer of the pharynx a nd T1 to T3 tumor disease appear warranted.