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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



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



Cancer 79(7): 1394-1400



BACKGROUND: The combination of vinorelbine (VNR), cisplatin (CDDP), and 5-fluorouracil (5-FU) has previously been shown to be active in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCHNC). This Multicenter Phase II study was carried out with the aim of evaluating the effectiveness of this combination m patients with previously untreated, unresectable locally advanced SCHNC. METHODS: Sixty patients with previously untreated, unresectable SCHNC were treated with CDDP 80 mg/m-2 on Days 1, 5-FU 600 mg/ml as a 4-hour infusion on Days 2-5, and VNR 25 mg/m-2 iv bolus on Days 2 and B. There were 15 patients with laryngeal carcinoma, 19 patients with oropharyngeal carcinoma, 15 with carcinoma in the oral cavity, 5 with carcinoma in the hypopharynx, and 4 with carcinoma in the maxillary sinus. Most patients (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: All patients completed the induction chemotherapy. After a mean of 3.86 cycles per patient, the overall response rate was 88% (95% confidence interval (CI), 82-94%), with a complete response rate of 23% (95% CI, 14-26%). Complete responses were more frequently seen in patients with N0-1 disease than in those with N2-3 disease (P = 0.037). No other statistically significant correlation between type of response and extent of disease was noted. Toxicity consisted mainly of myelosuppression and gastrointestinal side effects. After definitive locoregional treatment, 58% of patients were clinically free of disease. These patients included those who had complete response after induction chemotherapy, 19 of 39 patients who had partial response, and 2 with stable disease. Median disease free survival was 16 months, and median overall survival 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 effect. This regimen, which does not require hospitalization, should be compared with standard chemotherapy, such as the combination of CDDP and continuous-infusion 5-FU.

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Accession: 009724608

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PMID: 9083162

DOI: 10.1002/(sici)1097-0142(19970401)79:7<1394::aid-cncr17>3.0.co;2-v



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