丝裂霉素C在中危非肌层浸润性膀胱癌中的作用：一项系统评价和Meta分析
The Role of Mitomycin C in Intermediate-risk Non-muscle-invasive Bladder Cancer: A Systematic Review and Meta-analysis.
作者信息
Scilipoti Pietro, Ślusarczyk Aleksander, de Angelis Mario, Soria Francesco, Pradere Benjamin, Krajewski Wojciech, D'Andrea David, Mari Andrea, Giudice Francesco Del, Pichler Renate, Subiela José Daniel, Afferi Luca, Albisinni Simone, Mertens Laura, Laukhtina Ekaterina, Mori Keiichiro, Radziszewski Piotr, Shariat Shahrokh F, Necchi Andrea, Xylinas Evanguelos, Gontero Paolo, Rouprêt Morgan, Montorsi Francesco, Briganti Alberto, Moschini Marco
机构信息
Department of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.
Department of General, Oncological and Functional Urology, Medical University of Warsaw, Warsaw, Poland.
出版信息
Eur Urol Oncol. 2024 Dec;7(6):1293-1302. doi: 10.1016/j.euo.2024.06.005. Epub 2024 Jun 19.
BACKGROUND AND OBJECTIVE
Intravesical mitomycin C (MMC) instillations are recommended to prevent recurrence of intermediate-risk non-muscle-invasive bladder cancer (IR-NMIBC); however, the optimal regimen and dose are uncertain. Our aim was to assess the effectiveness of adjuvant MMC and compare different MMC regimens in preventing recurrence.
METHODS
We performed a comprehensive search in PubMed, Scopus, and Web of Science in November 2023 for studies investigating recurrence-free survival (RFS) among patients with IR-NMIBC who received adjuvant MMC. Prospective trials with different MMC regimens or other intravesical drugs as comparators were considered eligible.
KEY FINDINGS AND LIMITATIONS
Overall, 14 studies were eligible for systematic review and 11 for meta-analysis of RFS. Estimates of 1-yr, 2-yr, and 5-yr RFS rates were 84% (95% confidence interval [CI] 79-89%), 75% (95% CI 68-82%), and 51% (95% CI 40-63%) for patients treated with MMC induction plus maintenance, and 88% (95% CI 83-94%), 78% (95% CI 67-89%), and 66% (95% CI 57-75%) for patients treated with bacillus Calmette-Guérin (BCG) maintenance, respectively. Estimates of 2-yr RFS rates for MMC maintenance regimens were 76% (95% CI 69-84%) for 40 mg MMC (2 studies) and 66% (95% CI 60-72%) for 30 mg MMC (4 studies). Among the studies included, BCG maintenance provided comparable 2-yr RFS to 40 mg MMC with maintenance (78% vs 76%). RFS did not differ by MMC maintenance duration (>1 yr vs 1 yr vs <1 yr).
CONCLUSIONS AND CLINICAL IMPLICATIONS
MMC induction and maintenance regimens seem to provide short-term RFS rates equivalent to those for BCG maintenance in IR-NMIBC. For adjuvant induction and maintenance, 40 mg of MMC appears to be more effective in preventing recurrence than 30 mg. We did not observe an RFS benefit for longer maintenance regimens.
PATIENT SUMMARY
For patients with intermediate-risk non-muscle-invasive bladder cancer, bladder treatments with a solution of a drug called mitomycin C (MMC) seem to be as effective as BCG (bacillus Calmette-Guérin) in preventing recurrence after tumor removal. Further trials are needed for stronger evidence on the best MMC dose and treatment time.
背景与目的
推荐膀胱内灌注丝裂霉素C（MMC）以预防中危非肌层浸润性膀胱癌（IR-NMIBC）复发；然而，最佳方案和剂量尚不确定。我们的目的是评估辅助性MMC的有效性，并比较不同MMC方案在预防复发方面的效果。
方法
2023年11月，我们在PubMed、Scopus和Web of Science中进行了全面检索，以查找研究接受辅助性MMC治疗的IR-NMIBC患者无复发生存期（RFS）的研究。将不同MMC方案或其他膀胱内用药作为对照的前瞻性试验视为合格。
主要发现与局限性
总体而言，14项研究符合系统评价的标准，11项符合RFS的荟萃分析标准。接受MMC诱导加维持治疗的患者1年、2年和5年RFS率估计分别为84%（95%置信区间[CI]79-89%）、75%（95%CI 68-82%）和51%（95%CI 40-63%），接受卡介苗（BCG）维持治疗的患者分别为88%（95%CI 83-94%）、78%（95%CI 67-89%）和66%（95%CI 57-75%）。MMC维持方案的2年RFS率估计，40mg MMC为76%（95%CI 69-84%）（2项研究），30mg MMC为66%（95%CI 60-72%）（4项研究）。在纳入的研究中，BCG维持治疗与40mg MMC维持治疗的2年RFS相当（78%对76%）。RFS在MMC维持持续时间方面无差异（>1年对1年对<一年）。
结论与临床意义
MMC诱导和维持方案在IR-NMIBC中似乎能提供与BCG维持治疗相当的短期RFS率。对于辅助诱导和维持治疗，40mg MMC在预防复发方面似乎比30mg更有效。我们未观察到更长维持方案对RFS有获益。
患者总结
对于中危非肌层浸润性膀胱癌患者，用一种名为丝裂霉素C（MMC）的药物溶液进行膀胱治疗在预防肿瘤切除后复发方面似乎与BCG（卡介苗）一样有效。需要进一步试验以获得关于最佳MMC剂量和治疗时间更有力的证据。
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