Pietro Scilipoti, Aleksander Ślusarczyk, Mario de Angelis, Francesco Soria, Benjamin Pradere, Wojciech Krajewski, David D'Andrea, Andrea Mari, Francesco Del Giudice, Renate Pichler, José Daniel Subiela, Luca Afferi, Simone Albisinni, Laura Mertens, Ekaterina Laukhtina, Keiichiro Mori, Piotr Radziszewski, Shahrokh F Shariat, Andrea Necchi, Evanguelos Xylinas, Paolo Gontero, Morgan Rouprêt, Francesco Montorsi, Alberto Briganti, Marco Moschini
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Our aim was to assess the effectiveness of adjuvant MMC and compare different MMC regimens in preventing recurrence.</p><p><strong>Methods: </strong>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.</p><p><strong>Key findings and limitations: </strong>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).</p><p><strong>Conclusions and clinical implications: </strong>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.</p><p><strong>Patient summary: </strong>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. 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引用次数: 0
摘要
背景和目的：建议膀胱内注射丝裂霉素C（MMC）以预防中危非肌浸润性膀胱癌（IR-NMIBC）复发，但最佳方案和剂量尚不确定。我们的目的是评估MMC辅助治疗的有效性，并比较不同的MMC治疗方案在预防复发方面的效果：我们于 2023 年 11 月在 PubMed、Scopus 和 Web of Science 上进行了一次全面搜索，以了解有关接受 MMC 辅助治疗的 IR-NMIBC 患者无复发生存率（RFS）的研究。以不同的 MMC 方案或其他膀胱内药物作为比较对象的前瞻性试验均符合条件：共有 14 项研究符合 RFS 的系统综述条件，11 项符合 RFS 的荟萃分析条件。MMC诱导加维持治疗患者的1年、2年和5年RFS估计值分别为84%（95%置信区间[CI] 79-89%）、75%（95% CI 68-82%）和51%（95% CI 40-63%）；卡介苗（BCG）维持治疗患者的1年、2年和5年RFS估计值分别为88%（95% CI 83-94%）、78%（95% CI 67-89%）和66%（95% CI 57-75%）。据估计，40 毫克 MMC（2 项研究）和 30 毫克 MMC（4 项研究）维持治疗方案的 2 年 RFS 率分别为 76%（95% CI 69-84%）和 66%（95% CI 60-72%）。在纳入的研究中，卡介苗维持治疗与40毫克MMC维持治疗的2年RFS相当（78% vs 76%）。不同的 MMC 维持时间（>1 年 vs 1 年 vs 结论和临床意义）对 RFS 没有影响：在IR-NMIBC中，MMC诱导和维持方案的短期RFS率似乎与卡介苗维持方案相当。在辅助诱导和维持治疗中，40 毫克 MMC 似乎比 30 毫克更能有效预防复发。我们没有观察到较长的维持治疗方案有RFS获益：对于中危非肌浸润性膀胱癌患者，使用丝裂霉素 C（MMC）溶液进行膀胱治疗似乎与卡介苗（卡介苗）一样能有效预防肿瘤切除后的复发。关于丝裂霉素 C 的最佳剂量和治疗时间，还需要进一步的试验来提供更有力的证据。
The Role of Mitomycin C in Intermediate-risk Non-muscle-invasive Bladder Cancer: A Systematic Review and Meta-analysis.
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.
期刊介绍：
Journal Name: European Urology Oncology
Affiliation: Official Journal of the European Association of Urology
Focus:
First official publication of the EAU fully devoted to the study of genitourinary malignancies
Aims to deliver high-quality research
Content:
Includes original articles, opinion piece editorials, and invited reviews
Covers clinical, basic, and translational research
Publication Frequency: Six times a year in electronic format
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