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中低危非肌層浸潤性膀胱癌短期輔助灌注與術后即刻灌注吡柔比星的復發率比較

    2016-12-7

Yoshio Naya, MasakatsuOishi et al, J ClinOncol 33, 2015 (suppl; abstr e15523)
京都府立大學醫學院
本研究通過隨機前瞻性多中心試驗,對比了中低危非肌層浸潤性膀胱癌在進行尿道切除術(TURBT)后,即刻灌注化療與短期輔助灌注化療的術后復發率。
共106例中低危復發風險的非肌層浸潤性膀胱癌患者。組A術后即刻灌注吡柔比星30mg;組B術后每周灌注吡柔比星30mg,連續8周。術后所有患者每三個月進行一次膀胱鏡及尿道細胞檢查。
即刻灌注組(組A)2年無復發率為65.3%,短期灌注組(組B)為87.2%(P=0.038)。中危復發患者的2年無復發率,組A危62.3%,組B86.8%(p=0.0261)。所有病人均無疾病進展。組A不良反應發生率為0%,組B為24.4%。均無3級或以上不良反應發生。
對于中危復發患者術后每周灌注吡柔比星30mg,連續8周方案可有效降低復發風險,且無嚴重不良反應。本研究為經TURBT的中危復發NMIBC患者提供了一個更加合理有效的化療方案。

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.



  

 

 
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