BA08 研究：顺铂、甲氨蝶呤和长春碱（CMV）治疗单纯尿路上皮鳞癌的开放标签、单臂、非随机、2 期临床试验。
BA08: An open-label, single-arm, non-randomised, phase 2 trial of cisplatin, methotrexate and vinblastine (CMV) for pure squamous cell cancer of the urinary tract.
机构信息
Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom.
Christie Hospital, Manchester, United Kingdom.
出版信息
PLoS One. 2019 Jan 16;14(1):e0210785. doi: 10.1371/journal.pone.0210785. eCollection 2019.
BACKGROUND
Pure squamous cell carcinoma (SCC) of the urinary tract is rare in the UK and has a poor prognosis compared with transitional cell carcinoma (TCC). Cisplatin based chemotherapy has been shown to be effective in TCC.
METHODS
Patients with T3-T4, pelvic relapsed, nodal or metastatic SCC of the urinary tract were recruited into an open-label, single-arm, non-randomised, phase 2 trial evaluating the activity and safety of cisplatin, methotrexate and vinblastine (CMV) chemotherapy. CMV was given as three 21-day cycles of methotrexate 30mg/m2 (day 1 & 8), vinblastine 4mg/m2 (day 1 & 8) and cisplatin 100mg/m2 (day 2).
RESULTS
38 patients were recruited. Overall response was 39% (95% CI 24%, 55%)-13% CR and 26% PR. Median OS was 7.8 months (95% CI 3.4, 12.6) with 39% 1-year survival. Toxicity was acceptable.
CONCLUSION
CMV is well tolerated and active in patients with pure SCC of the urinary tract.
背景
英国罕见纯尿路鳞状细胞癌（SCC），与移行细胞癌（TCC）相比预后较差。顺铂为基础的化疗已被证明对 TCC 有效。
方法
招募了 T3-T4、盆腔复发、淋巴结或转移性尿路 SCC 的患者，参加一项开放标签、单臂、非随机、2 期试验，评估顺铂、甲氨蝶呤和长春碱（CMV）化疗的活性和安全性。CMV 给予三个 21 天周期的甲氨蝶呤 30mg/m2（第 1 天和第 8 天）、长春碱 4mg/m2（第 1 天和第 8 天）和顺铂 100mg/m2（第 2 天）。
结果
共招募了 38 例患者。总体缓解率为 39%（95%CI 24%，55%）-13%CR 和 26%PR。中位 OS 为 7.8 个月（95%CI 3.4，12.6），1 年生存率为 39%。毒性可耐受。
结论
CMV 在纯尿路 SCC 患者中耐受良好且有效。
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