Hong Min Hee, Kim Chang Gon, Koh Yoon Woo, Choi Eun Chang, Kim Jinna, Yoon Sun Och, Kim Hye Ryun, Cho Byoung Chul
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Graduate School of Medical Science and Engineering, KAIST, Daejeon, Republic of Korea.
Head Neck. 2018 Jan;40(1):55-62. doi: 10.1002/hed.24933. Epub 2017 Oct 16.
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.
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 ) on days 1 and 8 plus cisplatin (80 mg/m ) 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.
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.
Administering vinorelbine plus cisplatin chemotherapy to patients with recurrent and/or metastatic salivary gland cancers is safe and effective.
本研究旨在调查长春瑞滨联合顺铂化疗对头颈部复发性和/或转移性唾液腺癌患者的疗效和安全性。
在这项单臂II期研究中，复发性和/或转移性唾液腺癌患者接受静脉注射长春瑞滨（25mg/m²），于第1天和第8天给药，联合顺铂（80mg/m²）于第1天给药，每3周进行1次，共4或6个周期。主要终点为客观缓解率。同时评估无进展生存期（PFS）、总生存期（OS）和不良事件。
2008年9月至2014年11月期间，40例复发性和/或转移性唾液腺癌患者接受了长春瑞滨联合顺铂化疗。客观缓解率为35.0%，包括1例完全缓解。中位PFS和OS分别为6.3个月和16.9个月。未发生与治疗相关的死亡。
对复发性和/或转移性唾液腺癌患者给予长春瑞滨联合顺铂化疗是安全有效的。
