Delayed high-dose intravesical epirubicin therapy of superficial bladder cancer - A way to reduce the side effects and increase the efficacy - A phase 2 trial
Delayed high-dose intravesical epirubicin therapy of superficial bladder cancer - A way to reduce the side effects and increase the efficacy - A phase 2 trial
复制标题
DOI：
10.1159/000058438
复制
发表时间：
2002-01-01
影响因子：
1.6
通讯作者：
Pagano, F
中科院分区：
文献类型：
--
作者：
Bassi, PF;Spinadin, R;Pagano, F
简介：膀胱内表阿霉素是一种广泛用于治疗浅表性膀胱癌的药物。据报道，剂量和活性之间存在直接关系：不幸的是，剂量增加也增加了治疗相关副作用的频率和强度。材料与方法：一项2期试验旨在评价延迟（每两周一次）高剂量（80 mg）表阿霉素治疗浅表性膀胱癌的毒性和活性。对30例中危表浅性膀胱癌（mTa，G2期）患者采用经尿道电切加膀胱灌注治疗：每2周给予80 mg表阿霉素溶于50 ml无菌生理盐水中，共6次（延迟方案）。随访3 ~ 26个月。30例患者中有11例（37%）发生了需要特定药物治疗的膀胱内外照射局部不良反应（根据NCI-CTC v.2.0，1999，分级大于或等于2）。未观察到与给药相关的全身毒性。结果如下：在29例可评价患者中，22例（76%）在诱导疗程后无疾病，6例（21%）浅表性膀胱癌复发，1例（3%）肿瘤进展。结论：延迟（每两周一次滴注）高剂量（80 mg）膀胱内表阿霉素方案的副作用是可以接受的，并显示出有价值的治疗影响中度风险的浅表性膀胱癌患者。版权所有（C）2002 S. KargerAG，巴塞尔。
Introduction: Intravesical epirubicin is a widely used agent for the treatment of superficial bladder cancer. A direct relationship between dose and activity has been reported: unfortunately the dose increase also increased the frequency and the intensity of treatment-related side effects. Materials and Methods: A phase 2 trial was designed to evaluate the toxicity and the activity of a delayed (biweekly) high-dose (80 mg) epirubicin therapy of superficial bladder cancer. Thirty patients with intermediate risk superficial bladder cancer (stage mTa, G2) have been treated with transurethral resection and epirubicin intravesical therapy: the patients were given 80 mg epirubicin in 50 ml sterile saline every 2 weeks for 6 times (delayed regimen). The follow-up ranged from 3 to 26 months. Eleven of 30 (37%) patients experienced a local adverse reaction to intravesical epirubicin requiring specific medication (grade greater than or equal to2 according to NCI-CTC v.2.0, 1999). No systemic toxicity related to the treatment was observed. Results: Out of the 29 evaluable patients, 22 (76%) were free of disease after the induction course, 6 (21%) had superficial bladder cancer recurrences and 1 (3%) experienced tumor progression. Conclusion: A delayed (biweekly instillation) high-dose (80 mg) intravesical epirubicin regimen was acceptable in terms of side effects and showed a worthwhile therapeutical impact in patients with intermediate risk superficial bladder cancer. Copyright (C) 2002 S. KargerAG, Basel.