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Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study
Li Ning-chen1; Ye Zhang-qun2; Na Yan-qun1; CUA THP Immediate Instillations
关键词pirarubicin instillation therapy non-muscle-invasive bladder cancer randomized clinical trial
刊名CHINESE MEDICAL JOURNAL
2013-08-05
DOI10.3760/cma.j.issn.0366-6999.20131042
126期:15页:2805-2809
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
资助者Chinese Urological Association ; Shenzhen Main Luck Pharmaceutical Co., Ltd, China ; Chinese Urological Association ; Shenzhen Main Luck Pharmaceutical Co., Ltd, China
研究领域[WOS]General & Internal Medicine
关键词[WOS]POSTOPERATIVE INSTILLATION ; FOLLOW-UP ; 7 EORTC ; RECURRENCE ; CARCINOMA ; RISK ; CHEMOTHERAPY ; EPIRUBICIN ; TRIALS
英文摘要

Background Immediate intravesical instillation of chemotherapeutic agents after transurethral resection (TUR) of nonmuscle invasive transitional cell bladder cancer has recently been suggested and has been proven to decrease the tumor recurrence rate significantly. This study is to evaluate the efficacy and safety of immediate intravesical instillation combined with regular instillations of Pirarubicin (THP (R)) as prophylaxis compared to regular instillations only after TUR operation.

Methods This was a prospective, randomized, multi-center, clinical study. Patients diagnosed with non-muscle invasive bladder cancer (Ta and T1) pathologically and suitable for TUR were enrolled randomly into two groups. In the study group, the patients received intravesical instillation within 24-hour post TURBT, followed by regular intravesical therapy using 30 mg/50 ml of THP (R) once a week for 8 weeks, and then once a month to 1 year postoperatively Among the patients. In the control group, patients received regular instillation only.

Results A total of 403 patients were enrolled into this study from 26 institutions in China. Among the potients, 210 were enrolled into the study group and 193 were enrolled into the control group. At the median follow-up of 18 months, the recurrence rate was 7.8% in the study group, significantly lower than that in the control group (14.3%; P=0.042). Subgroup analysis showed that the recurrence rate in low and intermediate-risk patients was significantly lower in the study group (6.8%) than in the control group (14.0%; P=0.047), although no significant differences were found in high-risk patients.

Conclusion One immediate dose of THP (R) 30 mg after TURBT followed by regular intravesical therapy appears well tolerated and more effective than regular intravesical therapy for preventing tumor recurrence, especially in low and intermediate-risk patients.

语种英语
资助者Chinese Urological Association ; Shenzhen Main Luck Pharmaceutical Co., Ltd, China ; Chinese Urological Association ; Shenzhen Main Luck Pharmaceutical Co., Ltd, China
WOS记录号WOS:000329015500002
引用统计
被引频次:5[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/64030
专题北京大学首钢医院
作者单位1.Peking Univ, Shougang Hosp, Wujieping Urol Ctr, Beijing 100144, Peoples R China
2.Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Urol, Wuhan 430030, Hunan, Peoples R China
推荐引用方式
GB/T 7714
Li Ning-chen,Ye Zhang-qun,Na Yan-qun,et al. Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study[J]. CHINESE MEDICAL JOURNAL,2013,126(15):2805-2809.
APA Li Ning-chen,Ye Zhang-qun,Na Yan-qun,&CUA THP Immediate Instillations.(2013).Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study.CHINESE MEDICAL JOURNAL,126(15),2805-2809.
MLA Li Ning-chen,et al."Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study".CHINESE MEDICAL JOURNAL 126.15(2013):2805-2809.
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