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Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial

医学 丝裂霉素C 泌尿系统 膀胱癌 危险系数 泌尿科 内科学 胃肠病学 置信区间 癌症 外科
作者
Yasuyoshi Miyata,Toshifumi Tsurusaki,Yoshiko Hayashida,Yushi Imasato,Kosuke Takehara,Daiyu Aoki,Masaharu Nishikido,Junichi Watanabe,Kensuke Mitsunari,Tomohiro Matsuo,Kenkichi Ohba,Keisuke Taniguchi,Hideki Sakai
出处
期刊:BJUI [Wiley]
卷期号:129 (4): 534-541 被引量:6
标识
DOI:10.1111/bju.15571
摘要

To compare the urinary pH, recurrence-free survival (RFS), and safety of adjuvant intravesical therapy in patients with non-muscle-invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara-C) therapy.A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara-C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.A total of 81 and 87 patients were randomised into the MMC and MMC + Ara-C groups, respectively. Overall, the RFS in the MMC + Ara-C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate-risk NMIBC, but not in those with high-risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara-C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara-C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18-0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara-C groups, respectively, without a significant difference (P = 0.113).Our randomised clinical trial suggested that intravesical therapy with MMC and Ara-C is useful and safe for patients with intermediate-risk NMIBC. Increase in urinary pH with Ara-C is speculated as a mechanism for increased anti-cancer effects.

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