Treatment of recurrent and/or metastatic squamous cell head and neck carcinoma with a combination of vinorelbine, cisplatin, and 5-fluorouracil: A multicenter phase II trial

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Abstract
Purpose:Vinorelbine has been demonstrated to be active against squamous cell carcinomas of the headneck (SCHNC) and lung. This multicenter phase II trial was carried out to evaluate the activity and tolerability of the combination of vinorelbine, cisplatin, and 5-fluorouracil given on an outpatient schedule in a series of 80 patients with recurrent SCHNC.Patients and methods:Eighty patients with recurrent and/ or metastatic SCHNC were treated with a combination of CDDP 80 mg/m2 on day 1, 5-FU 600 mg/m2 as a 4-hour infusion on days 2-5, and vinorelbine 25 mg/m2 on days 2 + 8. This cycle was repeated every 28 days. Most patients had oral cavity, larynx, or oropharynx carcinoma (88%). Forty-seven had previously received surgery alone, two radiotherapy alone, and 31 surgery plus radiotherapy. Seventy-two patients had locoregional recurrency, and eight had distant metastases.Results:According to an intent-to-treat analysis, complete response (CR) of a mean duration of 12.7 months was achieved in 13% of cases (95% CI 5%-21%), and partial response of 8.3+ months in 45% of patients (95% CI 33%-56%), for an overall response rate of 55% (95% CI 43%-65%). Nine patients (11%) showed no change, and 22 (28%) progressed. Five patients were not evaluable for response and toxicity. CR were seen more frequently in patients pre-treated with only surgery than in those who had also received radiotherapy (15% vs. 9%; p = 0.7). No statistically significant differences in response rate according to site of primary tumor were found (p = 0.8, NS). The received dose intensities of 5-FU, CDDP, and VNR were 90%, 92%, and 82%, respectively. The overall survival of the series as a whole was 9.7+ months (range 4-27). Toxicity was generally acceptable. Grades 3 and 4 leukopnia were recorded in 11% and 5% of patients, respectively. Noteworthy was the occurrence of pain at the tumor site after vinorele administration in 5 patients.Conclusion:The combination regimen of CDDP, 5-FU and vinorelbine is quite active in the treatment of metastatic and/or recurrent SCHNC. This regimen should be tested as initial treatment in previously untreated patients and compared to a standard regimen in recurrent SCHNC.

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