Yoshio Naya, MasakatsuOishi et al, J ClinOncol 33, 2015 (suppl; abstr e15523)
京都府立大学医学院
本研究通过随机前瞻性多中心试验，对比了中低危非肌层浸润性膀胱癌在进行尿道切除术（TURBT）后，即刻灌注化疗与短期辅助灌注化疗的术后复发率。
共106例中低危复发风险的非肌层浸润性膀胱癌患者。组A术后即刻灌注吡柔比星30mg；组B术后每周灌注吡柔比星30mg，连续8周。术后所有患者每三个月进行一次膀胱镜及尿道细胞检查。
即刻灌注组（组A）2年无复发率为65.3%，短期灌注组（组B）为87.2%（P=0.038）。中危复发患者的2年无复发率，组A危62.3%，组B86.8%（p=0.0261）。所有病人均无疾病进展。组A不良反应发生率为0%，组B为24.4%。均无3级或以上不良反应发生。
对于中危复发患者术后每周灌注吡柔比星30mg，连续8周方案可有效降低复发风险，且无严重不良反应。本研究为经TURBT的中危复发NMIBC患者提供了一个更加合理有效的化疗方案。

Effect of short term adjuvant intravesical chemotherapy on recurrence rates compared with one immediate postoperative intravesical chemotherapy in patients with non muscle invasive bladder carcinoma with low or intermediate recurrent risk.

Subcategory:Bladder Cancer
Category:Genitourinary (Nonprostate) Cancer
Meeting:2015 ASCO Annual Meeting
Session Type and Session Title:
This abstract will not be presented at the 2015 ASCO Annual Meeting but has been published in conjunction with the meeting.
Abstract Number:e15523
Citation:
J ClinOncol 33, 2015 (suppl; abstr e15523)
Author(s):
Yoshio Naya, MasakatsuOishi, Takashi Ueda, Hiroyuki Nakanishi, Terukazu Nakamura, Fumiya Hongo, Kazumi Kamoi, Koji Okihara, Tsuyoshi Iwata, Motohiro Kanazawa, Kazuya Mikami, Hiroaki Miyashita, Tsuneharu Miki, KPUM Oncology Study Group; Kyoto Prefectural University of Medicine, Kyoto, Japan; Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan; Departments of Translational Cancer Drug Development and Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan; Department of Urology, Matsushita Memorial Hospital, Moriguchi, Japan; Department of Urology, Ohmihachiman City Hospital, Ohmihachiman, Japan

Abstract Disclosures
Abstract:
Background: We present a randomized, prospective, multicenter study comparing one immediate postoperative intravesical chemotherapy with short-term adjuvant intravesical chemotherapy after transurethral resection of bladder tumor (TURBT) for non-muscle invasive bladder carcinoma (NMIBC) with low or intermediate recurrent risk. Methods: This study was a multicenter, prospective, randomized controlled trial, and was approved by the ethics committees of Kyoto Prefectural University of Medicine in September 2010. One hundred six patients with low or intermediate recurrent risk of NMIBC were randomized to one immediate postoperative intravesical instillation of pirarubicin (THP) 30mg (Group A), or additional intravesical chemotherapy of THP 30mg weekly for 8 weeks (Group B). The patients were examined by cystoscopy and urine cytological examination every 3 months after TURBt to determine bladder tumor recurrence. Results: The 2-year recurrence free rate were 65.3% for Group A and 87.2% for Group B, respectively (log rank test, p = 0.038). In patients with intermediate recurrent risk, the 2year recurrence free rate were 62.3% for Group A and 86.8% in group B, respectively (log rank test, p = 0.0261). There was no patient with progression during this period. Adverse events were documented in 0% and 24.4% in Group A and Group B, respectively. There was no patient with severe adverse event (Grade 3 or more). Conclusions: Additional instillation of THP 30mg weekly for 8 weeks reduced the risk of tumor recurrence without severe toxicity in NMIBC patients with intermediate recurrent risk. Our data provide a rationale for adjuvant intravesical chemotherapy after TURBT in NMIBC patients with intermediate recurrent risk.