VINORELBINE, CISPLATIN, AND 5-FLUOROURACIL AS INITIAL TREATMENT FOR PREVIOUSLY UNTREATED, UNRESECTABLE SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - RESULTS OF A PHASE-II MULTICENTER STUDY

BACKGROUND. The combination of vinorelbine (VNR), cisplatin (CDDP), an d 5-fluorouracil (5-FU) has previously been shown to be active in recu rrent and/or metastatic squamous cell carcinoma of the head and neck ( SCHNC). This multicenter Phase II study was carried out with the aim o f evaluating the effectiveness of this combination in patients with pr eviously untreated, unresectable locally advanced SCHNC. METHODS. Sixt y patients with previously untreated, unresectable SCHNC were treated with CDDP 80 mg/m(2) on Days 1, 5-FU 600 mg/m(2) as a 4-hour infusion on Days 2-5, and VNR 25 mg/m(2) iv bolus on Days 2 and 8. There were 1 5 patients with laryngeal carcinoma, 19 patients with oropharyngeal ca rcinoma, 15 with carcinoma in the oral cavity, 5 with carcinoma in the hypopharynx, and 4 with carcinoma in the maxillary sinus. Most patien ts (78%) had Stage IV disease. After achievement of the best possible objective response, patients were subjected to definitive locoregional treatment, i.e., radiotherapy and/or surgery, as appropriate. RESULTS . AU patients completed the induction chemotherapy. After a mean of 3. 86 cycles per patient, the overall response rate was 88% (95% confiden ce interval [CI], 82-94%), with a complete response rate of 23% (95% C I, 14-26%). Complete responses were more frequently seen in patients w ith NO-1 disease than in those with N2-3 disease (P = 0.037). No other statistically significant correlation between type of response and ex tent of disease was noted. Toxicity consisted mainly of myelosuppressi on and gastrointestinal side effects. After definitive locoregional tr eatment, 58% of patients were clinically free of disease. These patien ts included those who had complete response after induction chemothera py, 19 of 39 patients who had partial response, and 2 with stable dise ase. Median disease free survival was 16 months, and median overall su rvival was 23 months. CONCLUSIONS. The combination regimen of CDDP, 5- FU, and VNR was very active in previously untreated SCHNC. It was well tolerated in most cases, and neurotoxicity was not a major side effec t. This regimen, which does not require hospitalization, should be com pared with standard chemotherapy, such as Lire combination of CDDP and continuous-infusion 5-FU. (C) 1997 American Cancer Society.