Yoshio Naya, MasakatsuOishi et al, J ClinOncol 33, 2015 (suppl; abstr e15523)
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.
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.
J ClinOncol 33, 2015 (suppl; abstr e15523)
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
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.