Intravesical therapy with pertussis toxin before radical cystectomy in patients with bladder cancer:: A Phase I study
Intravesical therapy with pertussis toxin before radical cystectomy in patients with bladder cancer:: A Phase I study
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DOI：
10.1016/s0090-4295(99)00154-5
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发表时间：
1999-09-01
期刊：
影响因子：
2.1
通讯作者：
Rübben, H
中科院分区：
文献类型：
--
作者：
Otto, T;Lümmen, G;Rübben, H
目标。目的：探讨百日咳毒素(PTX)膀胱内注射对肿瘤细胞的毒副作用，因为PTX在体内外均能抑制肿瘤细胞的运动，是一种很有前途的抗癌治疗方法。我们启动了一项I期研究，并在根治性膀胱切除术前测量了PTX膀胱内灌注的效果。研究终点为PTX相关副作用。PTX分5个剂量水平滴注，从14mUg开始，持续到72mg.15名患者被纳入研究，年龄中位数为。PTX膀胱内灌注无局部或全身副作用(根据美国国家癌症研究所毒性标准为0级)。PTX治疗是安全和耐受性良好的，剂量在72mUg以下时没有任何明显的局部或全身毒性。因此，PTX对局部肿瘤的影响应在II期研究中进行评估。(C)1999，爱思唯尔科学公司。
Objectives. To ascertain the side effects of intravesical instillation of pertussis toxin (PTX) because it inhibits tumor cell motility in vitro and in vivo and seems to be a promising therapeutic approach against cancer.Methods. We initiated a Phase I study and measured the effect of intravesical instillation of PTX before radical cystectomy. Study end points were PTX-related side effects. PTX was instilled at five dose levels, starting with 14 mu g and continuing to 72 mu g.Results. Fifteen patients, with a median age of 64 years, were included in the study. Intravesical instillation of PTX was without local or systemic side effects (grade 0, according to National Cancer Institute toxicity criteria).Conclusions. Treatment with PTX was safe and well tolerated without any significant local or systemic toxicity in dosages up to 72 mu g. Therefore, the influence of PTX on local tumor should be evaluated in a Phase II study. (C) 1999, Elsevier Science Inc.