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.

中文翻译：

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BA08：顺铂，甲氨蝶呤和长春碱（CMV）治疗泌尿道纯鳞癌的开放标签，单臂，非随机，2期临床试验

背景

纯尿道鳞状细胞癌（SCC）在英国很少见，与移行细胞癌（TCC）相比，预后较差。已显示基于顺铂的化学疗法在TCC中有效。

方法

招募患有T3-T4，骨盆复发，淋巴结转移或转移性SCC的患者参加一项开放标签，单组，非随机，2期试验，评估顺铂，甲氨蝶呤和长春碱（CMV）的活性和安全性化学疗法。给予CMV的三个21天周期为甲氨蝶呤30mg / m ²（第1和8天），长春碱4mg / m ²（第1和8天）和顺铂100mg / m ²（第2天）。

结果

招募了38名患者。总体反应为39％（95％CI 24％，55％）– 13％CR和26％PR。OS中位数为7.8个月（95％CI 3.4，12.6），一年生存率为39％。毒性是可以接受的。

结论

单纯尿路SCC患者对CMV的耐受性良好且活跃。