目的:建议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)的复发;然而,最佳治疗方案和剂量尚不确定.我们的目的是评估辅助MMC的有效性,并比较不同的MMC方案预防复发。
方法:我们在PubMed中进行了全面的搜索,Scopus,和WebofScience于2023年11月进行的研究,调查接受辅助MMC的IR-NMIBC患者的无复发生存率(RFS)。使用不同MMC方案或其他膀胱内药物作为对照的前瞻性试验被认为是合格的。
■总的来说,14项研究有资格进行系统评价,11项研究有资格进行RFS的荟萃分析。估计一年,2年,5年RFS率为84%(95%置信区间[CI]79-89%),75%(95%CI68-82%),接受MMC诱导加维持治疗的患者为51%(95%CI40-63%),和88%(95%CI83-94%),78%(95%CI67-89%),接受卡介苗(BCG)维持治疗的患者占66%(95%CI57-75%),分别。对于40mgMMC(2项研究),MMC维持方案的2年RFS率估计为76%(95%CI69-84%),对于30mgMMC(4项研究)为66%(95%CI60-72%)。在包括的研究中,卡介苗维持提供了与维持40mgMMC相当的2年RFS(78%对76%)。RFS在MMC维持时间上没有差异(>1年vs1年vs<1年)。
结论:MMC诱导和维持方案提供的短期RFS率与IR-NMIBC中BCG维持的RFS率相当。对于佐剂诱导和维持,40毫克的MMC似乎比30毫克更有效地预防复发。我们没有观察到长期维持方案的RFS益处。
结果:对于中危非肌层浸润性膀胱癌患者,用称为丝裂霉素C(MMC)的药物进行膀胱治疗似乎与卡介苗(卡介苗)一样有效,可以预防肿瘤切除后的复发。需要进一步的试验以获得关于最佳MMC剂量和治疗时间的更强有力的证据。
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.
UNASSIGNED: 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: 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.
RESULTS: 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.