Ta、T1膀胱移行细胞癌术后THP(吡柔比星)即刻灌注联合常规灌注预防复发—一项前瞻、随机、多中心临床研究

DOI: 10.3760/cma.j.issn.0366-6999.20131042

Peking University Wujieping Urology Center, Peking University Shougang Hospital, Beijng 100144, China (Li NC and Na YQ)

Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China (Ye ZQ)

Correspondence to: LI Ning-chen, Peking University Wujieping Urology Center, Peking University Shougang Hospital, Beijng 100144, China (Email: ningchenli@)

The study was supported by the Chinese Urological Association and Shenzhen Main Luck Pharmaceutical Co., Ltd, China.

Conflicts of interests: The study was supported partly by the Shenzhen Main Luck Pharmaceutical Co., Ltd, China.

Original article

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-chen, YE ZHANG-qun, NA Yan-qun; CUA THP ® Immediate Instillations Study Group

Keywords: pirarubicin; instillation therapy; non-muscle-invasive bladder cancer; randomized clinical trial

Background Immediate intravesical instillation of chemotherapeutic agents after transurethral resection (TUR) of non-muscle 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 ®) 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 (T a 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 ® 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 ® 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.

Chin Med J 2013;126 (15): 2805-2809

A

lthough transurethral resection (TUR) is the standard treatment for non-muscle-invasive bladder tumors, 40%–80% of tumors recur despite complete resection.1 Intravesical chemotherapy as prophylactic treatment after TUR of Ta/ T1 disease has been shown to decrease short-term recurrence rates by approximately 20% and long-term rates by 8.2%.2-4 Chemotherapeutic agents, such as mitomycin C (MMC), pirarubicin (THP ®), and epirubicin (EPI), have often been used to prevent tumor recurrence in China,2,5-7 although the intravesical instillation of Bacille Calmette-Guerin has been shown to be more effective than chemotherapeutic agents in prophylactic treatment.7

Immediate intravesical instillation of chemotherapeutic agents after TUR has recently been suggested and has been proven to decrease the tumor recurrence rate significantly, especially in patients at low and intermediate risk of recurrence.6,8-10 In China, THP ® has been widely used in patients after TUR as prophylactic treatment.11-13 However, only a small number of studies of the efficacy and safety of THP ® as immediate instillation have been done around the world. Therefore, we designed this prospective, randomized, controlled study to investigate the efficacy and safety of immediate intravesical instillation combined with regular instillations using THP ® as prophylaxis compared to regular instillations after TUR of non-muscle invasive

transitional cell bladder cancer.

METHODS

Study design

From January 2007 to September 2009, 403 patients were enrolled at 26 urologic centers in China in a prospective, randomized, multicenter study conducted by the Chinese Urological Association Bladder Cancer Group. The study protocol was designed to meet the criteria of the Declaration of Helsinki , including written informed consent provided by all patients. Ethics approval was granted by the Ethical Committee of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology.