Min Hee Hong1, Chang Gon Kim1,2, Yoon Woo Koh3, Eun Chang Choi3, Jinna Kim4, Sun Och Yoon5, Hye Ryun Kim1, Byoung Chul Cho1. 1. Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 2. Graduate School of Medical Science and Engineering, KAIST, Daejeon, Republic of Korea. 3. Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea. 4. Department of Radiology, Yonsei University College of Medicine, Seoul, Republic of Korea. 5. Department of Pathology, Yonsei University College of Medicine, Seoul, Republic of Korea.
Abstract
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/m2 ) on days 1 and 8 plus cisplatin (80 mg/m2 ) 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 receivedvinorelbine 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.
RCT Entities:
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/m2 ) on days 1 and 8 plus cisplatin (80 mg/m2 ) 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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