Partial Versus Complete Bacillus Calmette-Guérin Intravesical Therapy and Bladder Cancer Outcomes in High-risk Non-muscle-invasive Bladder Cancer: Is NIMBUS the Full Story?
Partial Versus Complete Bacillus Calmette-Guérin Intravesical Therapy and Bladder Cancer Outcomes in High-risk Non-muscle-invasive Bladder Cancer: Is NIMBUS the Full Story?
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DOI：
10.1016/j.euros.2021.01.009
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发表时间：
2021-04
影响因子：
2.5
通讯作者：
Schroeck FR
中科院分区：
文献类型：
--
作者：
Rezaee ME;Ismail AAO;Okorie CL;Seigne JD;Lynch KE;Schroeck FR
考虑到全球短缺和NIMBUS试验的提前终止，了解降低卡介苗（BCG）治疗强度的意义非常重要。评估部分和完全BCG诱导与结局的相关性。这是一项回顾性队列研究，研究对象为2005年至2011年间诊断为高危非肌层浸润性膀胱癌（NMIBC;高级别[HG] Ta、T1或原位癌）的退伍军人，随访至2014年。将患者分为部分与完全BCG诱导（1至5次vs 5次或更多次滴注）。为了与NIMBUS试验进行比较，定义了部分BCG诱导亚组。使用倾向评分调整回归模型评估部分BCG诱导与复发和膀胱癌死亡风险的相关性。在540例患者中，114例（21.1%）接受了部分BCG诱导。部分或完全BCG诱导与HG Ta（5年累积发病率[CIn] 46.6% vs 53.9%，p = 0.38）或T1（5年CIn 47.1% vs 56.7，p = 0.19）疾病的复发风险无显著相关性。同样，我们也没有发现膀胱癌死亡的风险增加（HG Ta：5年时CIn为4.7% vs 5.4%，p = 0.87; T1：5年时CIn为10.0% vs 11.4%，p = 0.77）。NIMBUS样诱导与HG Ta疾病患者复发风险增加相关，尽管无统计学意义。不可测量的混杂是一种局限性。接受部分与完全卡介苗诱导的高危NMIBC患者的癌症结局相似，这表明需要未来的研究来确定如何为最大数量的患者优化卡介苗输送，特别是在全球短缺期间。接受卡介苗（BCG）部分疗程和完整疗程的患者结局相似。未来的研究需要确定如何最好地将BCG提供给最多的患者，特别是在药物短缺期间。接受部分卡介苗（BCG）诱导的高危非肌肉浸润性膀胱癌患者与接受完全BCG诱导的患者结局相似。需要更多的前瞻性试验来确定如何在全球短缺期间最大限度地提高BCG的使用率。
It is important to understand the implications of reduced bacillus Calmette-Guérin (BCG) treatment intensity, given global shortages and early termination of the NIMBUS trial. To assess the association of partial versus complete BCG induction with outcomes. This is a retrospective cohort study of veterans diagnosed with high-risk non–muscle-invasive bladder cancer (NMIBC; high grade [HG] Ta, T1, or carcinoma in situ) between 2005 and 2011 with follow-up through 2014. Patients were categorized into partial versus complete BCG induction (one to five vs five or more instillations). Partial BCG induction subgroups were defined for comparison with the NIMBUS trial. Propensity score–adjusted regression models were used to assess the association of partial BCG induction with risk of recurrence and bladder cancer death. Among 540 patients, 114 (21.1%) underwent partial BCG induction. Partial versus complete BCG induction was not significantly associated with the risk of recurrence in HG Ta (cumulative incidence [CIn] 46.6% vs 53.9% at 5 yr, p = 0.38) or T1 (CIn 47.1% vs 56.7 at 5 yr, p = 0.19) disease. Similarly, we found no increased risk of bladder cancer death (HG Ta: CIn 4.7%7vs 5.4% at 5 yr, p = 0.87; T1: CIn 10.0% vs 11.4% at 5 yr, p = 0.77). NIMBUS-like induction was associated with an increased risk of recurrence in patients with HG Ta disease, although not statistically significant. Unmeasured confounding is a limitation. Cancer outcomes were similar among high-risk NMIBC patients who underwent partial versus complete BCG induction, suggesting that future research is needed to determine how to optimize BCG delivery for the greatest number of patients, especially during global shortages. Outcomes were similar between patients receiving partial and complete courses of bacillus Calmette-Guérin (BCG) therapy. Future research is needed to determine how to best deliver BCG to the greatest number of patients, particularly during medication shortages. Patients with high-risk non–muscle-invasive bladder cancer who underwent partial bacillus Calmette-Guérin (BCG) induction experienced similar outcomes to those who received complete BCG induction. Additional prospective trials are needed to determine how to maximize BCG utilization for the greatest number of patients during global shortages.
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影响因子：
6.6
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