Mann Patel, Aravind Rajagopalan, Ellen M Cahill, Kevin J Chua, Rachel Passarelli, John Pfail, Sai Krishnaraya Doppalapudi, David Golombos, Thomas Jang, Vignesh T Packiam, Saum Ghodoussipour
{"title":"卡介苗-谷氨酰胺诱导治疗非肌性浸润性膀胱癌的耐受性和疗效。","authors":"Mann Patel, Aravind Rajagopalan, Ellen M Cahill, Kevin J Chua, Rachel Passarelli, John Pfail, Sai Krishnaraya Doppalapudi, David Golombos, Thomas Jang, Vignesh T Packiam, Saum Ghodoussipour","doi":"10.14440/bladder.2024.0051","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Intravesical Bacillus Calmette-Guérin (BCG) is the standard treatment for intermediate-risk, high-grade, and high-risk non-muscle invasive bladder cancer (NMIBC). However, it is associated with adverse effects, potentially causing treatment interruptions or discontinuation.</p><p><strong>Objectives: </strong>This study analyzed the tolerability and efficacy of induction BCG, with associated patient- and disease-related factors.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on BCG-naive patients diagnosed with high-grade NMIBC, who received induction BCG at our institution between 2011 and 2021. Tolerability was defined as the completion of a 6-week induction course of BCG without treatment interruption or discontinuation. Multivariable logistic regression was performed to determine risk factors associated with the inability to tolerate treatment.</p><p><strong>Results: </strong>Induction BCG was given to 203 NMIBC patients, where 147 (72%) patients tolerated the treatment. Treatment interruptions occurred in 44 (22%) patients, while 12 (5.9%) patients discontinued the treatment. The median length of interruption was 1 week, primarily due to concerns about urinary tract infection (UTI) (<i>n</i> = 18, 41%) or gross hematuria (<i>n</i> = 5, 11%). No significant difference in 1-year recurrence rates was observed between those who tolerated BCG and those who did not (50% vs. 48%). Risk factors associated with the inability to tolerate induction BCG included male sex (odds ratio [OR] = 5.76, <i>p</i> < 0.01), hypertension (OR = 3.47, <i>p</i> = 0.02), and low pre-treatment hemoglobin levels (OR = 0.73, <i>p</i> = 0.03).</p><p><strong>Conclusion: </strong>Inability to tolerate BCG occurred in 28% of patients, with 5.9% experiencing discontinuation. Interruptions were short, mostly concerning UTI, and rarely leading to discontinuation. Poor tolerability was associated with male sex, hypertension, and low pre-treatment hemoglobin levels, highlighting critical targets for reducing the risk of BCG interruption or discontinuation.</p>","PeriodicalId":72421,"journal":{"name":"Bladder (San Francisco, Calif.)","volume":"12 2","pages":"e21200031"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12308126/pdf/","citationCount":"0","resultStr":"{\"title\":\"Tolerability and efficacy of induction Bacillus Calmette-Guérin for non-muscle invasive bladder cancer.\",\"authors\":\"Mann Patel, Aravind Rajagopalan, Ellen M Cahill, Kevin J Chua, Rachel Passarelli, John Pfail, Sai Krishnaraya Doppalapudi, David Golombos, Thomas Jang, Vignesh T Packiam, Saum Ghodoussipour\",\"doi\":\"10.14440/bladder.2024.0051\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Intravesical Bacillus Calmette-Guérin (BCG) is the standard treatment for intermediate-risk, high-grade, and high-risk non-muscle invasive bladder cancer (NMIBC). However, it is associated with adverse effects, potentially causing treatment interruptions or discontinuation.</p><p><strong>Objectives: </strong>This study analyzed the tolerability and efficacy of induction BCG, with associated patient- and disease-related factors.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on BCG-naive patients diagnosed with high-grade NMIBC, who received induction BCG at our institution between 2011 and 2021. Tolerability was defined as the completion of a 6-week induction course of BCG without treatment interruption or discontinuation. Multivariable logistic regression was performed to determine risk factors associated with the inability to tolerate treatment.</p><p><strong>Results: </strong>Induction BCG was given to 203 NMIBC patients, where 147 (72%) patients tolerated the treatment. Treatment interruptions occurred in 44 (22%) patients, while 12 (5.9%) patients discontinued the treatment. The median length of interruption was 1 week, primarily due to concerns about urinary tract infection (UTI) (<i>n</i> = 18, 41%) or gross hematuria (<i>n</i> = 5, 11%). No significant difference in 1-year recurrence rates was observed between those who tolerated BCG and those who did not (50% vs. 48%). Risk factors associated with the inability to tolerate induction BCG included male sex (odds ratio [OR] = 5.76, <i>p</i> < 0.01), hypertension (OR = 3.47, <i>p</i> = 0.02), and low pre-treatment hemoglobin levels (OR = 0.73, <i>p</i> = 0.03).</p><p><strong>Conclusion: </strong>Inability to tolerate BCG occurred in 28% of patients, with 5.9% experiencing discontinuation. Interruptions were short, mostly concerning UTI, and rarely leading to discontinuation. Poor tolerability was associated with male sex, hypertension, and low pre-treatment hemoglobin levels, highlighting critical targets for reducing the risk of BCG interruption or discontinuation.</p>\",\"PeriodicalId\":72421,\"journal\":{\"name\":\"Bladder (San Francisco, Calif.)\",\"volume\":\"12 2\",\"pages\":\"e21200031\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12308126/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bladder (San Francisco, Calif.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14440/bladder.2024.0051\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bladder (San Francisco, Calif.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14440/bladder.2024.0051","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景：膀胱内卡介苗（BCG）是治疗中危、高级别、高风险非肌肉浸润性膀胱癌（NMIBC）的标准治疗方法。然而，它与不良反应有关，可能导致治疗中断或停止。目的：本研究分析诱导卡介苗的耐受性和疗效，以及相关的患者和疾病相关因素。方法：回顾性分析2011年至2021年在我院接受诱导BCG治疗的高级别NMIBC患者。耐受性定义为完成了6周的卡介苗诱导疗程，没有中断或停止治疗。采用多变量logistic回归来确定与不能耐受治疗相关的危险因素。结果：203例NMIBC患者接受诱导BCG治疗，其中147例（72%）耐受。44例（22%）患者出现治疗中断，12例（5.9%）患者停止治疗。中断的中位长度为1周，主要是由于担心尿路感染（n = 18, 41%）或总血尿（n = 5, 11%）。耐受卡介苗组和不耐受卡介苗组的1年复发率无显著差异（50% vs 48%）。与诱导卡介苗不能耐受相关的危险因素包括男性（优势比[OR] = 5.76, p < 0.01）、高血压（OR = 3.47, p = 0.02）和治疗前低血红蛋白水平（OR = 0.73, p = 0.03）。结论：28%的患者无法耐受卡介苗，5.9%的患者停药。中断时间很短，主要与尿路感染有关，很少导致中断。耐受性差与男性、高血压和治疗前血红蛋白水平低有关，这突出了降低卡介苗中断或停药风险的关键目标。
Tolerability and efficacy of induction Bacillus Calmette-Guérin for non-muscle invasive bladder cancer.
Background: Intravesical Bacillus Calmette-Guérin (BCG) is the standard treatment for intermediate-risk, high-grade, and high-risk non-muscle invasive bladder cancer (NMIBC). However, it is associated with adverse effects, potentially causing treatment interruptions or discontinuation.
Objectives: This study analyzed the tolerability and efficacy of induction BCG, with associated patient- and disease-related factors.
Methods: A retrospective analysis was conducted on BCG-naive patients diagnosed with high-grade NMIBC, who received induction BCG at our institution between 2011 and 2021. Tolerability was defined as the completion of a 6-week induction course of BCG without treatment interruption or discontinuation. Multivariable logistic regression was performed to determine risk factors associated with the inability to tolerate treatment.
Results: Induction BCG was given to 203 NMIBC patients, where 147 (72%) patients tolerated the treatment. Treatment interruptions occurred in 44 (22%) patients, while 12 (5.9%) patients discontinued the treatment. The median length of interruption was 1 week, primarily due to concerns about urinary tract infection (UTI) (n = 18, 41%) or gross hematuria (n = 5, 11%). No significant difference in 1-year recurrence rates was observed between those who tolerated BCG and those who did not (50% vs. 48%). Risk factors associated with the inability to tolerate induction BCG included male sex (odds ratio [OR] = 5.76, p < 0.01), hypertension (OR = 3.47, p = 0.02), and low pre-treatment hemoglobin levels (OR = 0.73, p = 0.03).
Conclusion: Inability to tolerate BCG occurred in 28% of patients, with 5.9% experiencing discontinuation. Interruptions were short, mostly concerning UTI, and rarely leading to discontinuation. Poor tolerability was associated with male sex, hypertension, and low pre-treatment hemoglobin levels, highlighting critical targets for reducing the risk of BCG interruption or discontinuation.
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