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 resectable squamous cell carcinoma of the oral cavity and pharynx were entered into the study. The PEM regimen consisted of cisplatin 60 mg/m2 2 h infusion on day 1, etoposide 40 mg/m2 1 h infusion on days 1, 2 and 3 and mitomycin-C 7 mg/m2 i.v. bolus on day 1. RESULTS: Among the 32 patients entered into this trial, eight were disqualified from the analysis. Of the remaining 24 patients, 13 were given neoadjuvant chemotherapy (NAC) and 11 underwent surgery alone. Among the 13 patients who received NAC, four achieved a complete response (31%) and three a partial response (23%), with an overall response rate of 54%. Myelosuppression was a major side effect. Thrombocytopenia and anemia were dose-limiting toxicities. Other adverse reactions, including mucositis, were all mild and transient. The overall 5-year survival after NAC and without NAC were 83 and 62%, respectively. The survival difference was not statistically significant (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 dosage and/or revise the administration schedule for cancer of the pharynx and T1 to T3 tumor disease appear warranted.
RCT Entities:
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 resectable squamous cell carcinoma of the oral cavity and pharynx were entered into the study. The PEM regimen consisted of cisplatin 60 mg/m2 2 h infusion on day 1, etoposide 40 mg/m2 1 h infusion on days 1, 2 and 3 and mitomycin-C 7 mg/m2 i.v. bolus on day 1. RESULTS: Among the 32 patients entered into this trial, eight were disqualified from the analysis. Of the remaining 24 patients, 13 were given neoadjuvant chemotherapy (NAC) and 11 underwent surgery alone. Among the 13 patients who received NAC, four achieved a complete response (31%) and three a partial response (23%), with an overall response rate of 54%. Myelosuppression was a major side effect. Thrombocytopenia and anemia were dose-limiting toxicities. Other adverse reactions, including mucositis, were all mild and transient. The overall 5-year survival after NAC and without NAC were 83 and 62%, respectively. The survival difference was not statistically significant (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 dosage and/or revise the administration schedule for cancer of the pharynx and T1 to T3 tumor disease appear warranted.
Authors: Remco de Bree; Gregory T Wolf; Bart de Keizer; Iain J Nixon; Dana M Hartl; Arlene A Forastiere; Missak Haigentz; Alessandra Rinaldo; Juan P Rodrigo; Nabil F Saba; Carlos Suárez; Jan B Vermorken; Alfio Ferlito Journal: Head Neck Date: 2017-08-17 Impact factor: 3.147