Long term results of a phase II trial of induction chemotherapy with uracil-ftegafur (UFT), vinorelbine and cisplatin (UFTVP) followed by radiotherapy concomitant with UFT and carboplatin (RT/UFTJ) in non-resectable locally advanced (stage IV-B) squamous cell head and neck carcinoma and peripheral blood stem cell support (PBSCS) with febrile neutropenia.

PURPOSE: To evaluate the response of advanced squamous cell head and neck carcinoma to a combination of induction chemotherapy and radiotherapy. METHODS: We present long-term results of a phase II trial of Induction Chemotherapy with UFT 200 mg/m(2) p.o. days 1 to 21, Vinorelbine 25 mg/m(2) i.v. days 1 and 8 and Cisplatin 100 mg/m(2) i.v. day 1 (UFTVP) each 21 days for 4 courses, followed by Radiotherapy concomitant with UFT 100 mg/m(2) p.o. daily and Carboplatin AUC = 0.5 i.v. weekly (RT/UFTJ) in patients (pts) with Non-Resectable Locally Advanced (Stage IV-B) Squamous Cell Head and Neck Carcinoma (IV-B-SCHNC). Primary endpoint was Complete Response to induction UFTVP and secondary endpoints were Disease Free Status Rate after locoregional treatment and long-term Overall Survival. Between 1994 and 1997, 32 pts were included. RESULTS: Complete Response to Induction UFTVP was 59% (95% CI: 48%-70%). Main toxicity of UFTVP was G 3,4 neutropenia (94% of pts; 25% developed febrile neutropenia and 1 of this pts dead). After Induction Chemotherapy with UFTVP, 30 pts received radiotherapy and 25 of them received concomitant Carboplatin and UFT (RT/UFTJ): main toxicity was mucositis (G3-4: 72%) and one patient died during RT/UFTJ because pneumonia. Twenty-five pts (78%) were alive and disease free at the end of the whole treatment. Actuarial 5 year Overall survival is 32%. CONCLUSION: Although toxicity is important, this approach has interesting activity and deserves further investigation.

Long-term results of a phase II trial of induction chemotherapy with uracil-ftegafur (UFT), vinorelbine, and cisplatin (UFTVP) followed by radiotherapy concomitant with UFT and carboplatin (RT/UFTJ) in a primary site preservation setting for resectable locally advanced squamous cell carcinoma of larynx and hypopharynx.

OBJECTIVE: We present long-term results of a phase II trial of induction chemotherapy (IC) with uracilftegafur (UFT) 200 mg/m orally days 1 to 21, vinorelbine 25 mg/m intravenously (IV) days 1 and 8, and cisplatin 100 mg/m IV day 1 (UFTVP) each for 21 days for 4 courses, followed by radiotherapy concomitant with UFT 100 mg/m orally daily and carboplatin (area under the curve [AUC] = 0.5 IV weekly) (RT/ UFTJ), without surgery to the primary site if response, in patients (pts) with resectable locally advanced squamous cell carcinoma of the larynx and hypopharynx. The primary endpoint was clinical complete response (CR) to induction UFTVP, and secondary endpoints were long-term overall survival (OS) and survival with primary site preservation (SPP). RESULTS: Between 1994 and 1997, 37 pts were included. CR to IC was 54% (95% confidence interval [CI] 43-65%). Main toxicity of UFTVP was G 3,4 neutropenia (73% of pts, 16% developed febrile neutropenia). After IC, primary site was treated with RT in 29 pts: 20 of them received RT/UFTJ (main toxicity mucositis G 3,4 70%). No pt died during treatment. Actuarial 5-year OS and SPP were 57% and 37%, respectively. CONCLUSIONS: This approach has significant activity and acceptable toxicity for achieving promising long-term OS and SPP and deserves further investigation.

Diabetes mellitus following cisplatin treatment.

The association between cisplatin treatment and diabetes mellitus was analyzed retrospectively in 219 patients with locally advanced squamous cell head and neck cancer treated in two consecutive trials with cisplatin-based induction chemotherapy. It was found that 11 patients (5%) developed diabetes mellitus during the treatment period, two cases presenting as hyperosmolar coma. The literature contains only sporadic descriptions of cases of hyperosmolar coma related to cisplatin chemotherapy. The present study was initiated owing to a case of hyperosmolar coma observed by us. We suggest that glycemia levels in patients receiving chemotherapy with a cisplatin-based regimen should be monitored regularly.