Background: The purpose of this study was to investigate the efficacy and safety of vinorelbine plus cisplatin chemotherapy in patients with recurrent and/or metastatic salivary gland cancer of the head and neck. Methods: In this single-arm phase II study, patients with recurrent and/or metastatic salivary gland cancer were treated with i.v. vinorelbine (25 mg/m 2 ) on days 1 and 8 plus cisplatin (80 mg/m 2 ) on day 1 every 3 weeks for 4 or 6 cycles. The primary endpoint was the objective response rate. Progression-free survival (PFS), overall survival (OS), and adverse events were also assessed. Results: Between September 2008 and November 2014, 40 patients with recurrent and/or metastatic salivary gland cancer received vinorelbine plus cisplatin chemotherapy. The objective response rate was 35.0%, including 1 complete response. Median PFS and OS rates were 6.3 months and 16.9 months, respectively. No treatment-related deaths occurred. Conclusion: Administering vinorelbine plus cisplatin chemotherapy to patients with recurrent and/or metastatic salivary gland cancers is safe and effective.
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