Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial

被引：197

作者：

Ito, Akihiro ^{[1
]}

Shintaku, Ichiro ^{[1
]}

Satoh, Makoto ^{[4
]}

Ioritani, Naomasa ^{[2
]}

Aizawa, Masataka ^{[2
]}

Tochigi, Tatsuo ^{[5
]}

Kawamura, Sadafumi ^{[5
]}

Aoki, Hiroshi ^{[5
]}

Numata, Isao ^{[6
]}

Takeda, Atsushi ^{[6
]}

Namiki, Shunichi ^{[6
]}

Namima, Takashige ^{[3
]}

Ikeda, Yoshihiro ^{[3
]}

Kambe, Koichi ^{[7
]}

Kyan, Atsushi ^{[8
]}

Ueno, Seiji ^{[9
]}

Orikasa, Kazuhiko ^{[1
]}

Katoh, Shinnosuke ^{[10
]}

Adachi, Hisanobu ^{[11
]}

Tokuyama, Satoru ^{[12
]}

Ishidoya, Shigeto ^{[1
]}

Yamaguchi, Takuhiro ^{[1
]}

Arai, Yoichi ^{[1
]}

机构：

[1] Tohoku Univ, Grad Sch Med, Sendai, Miyagi 980, Japan

[2] Sendai Shakai Hoken Hosp, Sendai, Miyagi, Japan

[3] Tohoku Rosai Hosp, Sendai, Miyagi, Japan

[4] Sen En Gen Hosp, Tagajo, Miyagi, Japan

[5] Miyagi Canc Ctr, Natori, Miyagi 9811293, Japan

[6] Osaki Citizen Hosp, Osaki, Japan

[7] Senseki Hosp, Higashihiroshima, Japan

[8] Shirakawa Kosei Gen Hosp, Shirakawa, Japan

[9] Kesennuma City Hosp, Kesennuma, Miyagi, Japan

[10] Ogachi Cent Hosp, Yuzawa, Japan

[11] Iwate Prefectural Iwai Hosp, Ichinoseki, Japan

[12] Iwaki Kyoritsu Gen Hosp, Iwaki, Fukushima, Japan

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 31卷 / 11期

关键词：

TRANSITIONAL-CELL CARCINOMA; TERM-FOLLOW-UP; MITOMYCIN-C; CLINICAL-TRIAL; RISK-FACTORS; CANCER; TUMORS; CHEMOTHERAPY; EXPERIENCE; RESECTION;

D O I：

10.1200/JCO.2012.45.2128

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose We evaluated the efficacy of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC). Patients and Methods From December 2005 to November 2008, 77 patients clinically diagnosed with UUT-UC from 11 institutions participating in the Tohoku Urological Evidence-Based Medicine Study Group were preoperatively enrolled in this study. Patients were randomly assigned to receive or not receive a single instillation of THP (30 mg in 30 mL of saline) into the bladder within 48 hours after nephroureterectomy. Cystoscopy and urinary cytology were repeated every 3 months for 2 years or until the occurrence of first bladder recurrence. Results Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group. Based on multivariate analysis, THP instillation (hazard rate [HR], 0.26; 95% CI, 0.07 to 0.91; P = .035) and open surgery (HR, 0.28; 95% CI, 0.09 to 0.84; P = .024) were independently predictive of a reduced incidence of bladder recurrence. Conclusion In this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations. J Clin Oncol 31:1422-1427. (C) 2013 by American Society of Clinical Oncology

引用

页码：1422 / 1427

页数：6

共 28 条

[1] COMPARATIVE INVESTIGATION ON USE OF (2''R)-4'-O-TETRAHYDROPYRANYL-ADRIAMYCIN AND ADRIAMYCIN AS INTRAVESICAL CHEMOTHERAPY FOR SUPERFICIAL BLADDER-TUMORS [J].