Luca Di Gianfrancesco, Mauro Ragonese, Massimiliano Foti, Giuseppe Palermo, Emilio Sacco, PierFrancesco Bassi, Marco Racioppi
{"title":"如何减少严重功能障碍患者卡介苗-谷氨酰胺停药。","authors":"Luca Di Gianfrancesco, Mauro Ragonese, Massimiliano Foti, Giuseppe Palermo, Emilio Sacco, PierFrancesco Bassi, Marco Racioppi","doi":"10.1097/CU9.0000000000000134","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Severe functional impairment is often considered a contraindication to intravesical therapy for nonmuscle-invasive bladder cancer (NMIBC). A tailored intravesical bacillus Calmette-Guérin (BCG) procedure was evaluated in high-risk (HR)-NMIBC patients with severe functional impairment.</p><p><strong>Materials and methods: </strong>Patients with a Katz Index score of 2 or less and an initial diagnosis of HR-NMIBC with atraumatic insertion of a Foley-type indwelling catheter, bladder emptying, and BCG instillation were prospectively treated; after 2 hours, the bladder was emptied and the catheter was removed (group A).After propensity score matching, 52 patients in group A were compared with that of 52 consecutive patients in group B using a retrospective database, with similar baseline/oncological characteristics and treated with standard intermittent catheterization. Moreover, groups A and B were compared with that of 130 consecutive patients (group C) retrospectively evaluated, with similar oncological characteristics but with a Katz Index score of 3 or greater and treated with standard intermittent catheterization.</p><p><strong>Results: </strong>The discontinuation rates were 11.5%, 35%, and 9% in groups A, B, and C, respectively (A vs. B, log-rank score 42.52 [<i>p</i> < 0.05]; B vs. C, 107.6 [<i>p</i> < 0.05]; A vs. C, 3.45 [<i>p</i> > 0.05]). The overall adverse event rates were 38.5%, 57.7%, and 39.2%, respectively (A vs. B, <i>p</i> = 0.04; B vs. C, 0.03; A vs. C, 0.92). The rates of severe adverse events were 1.9%, 1.9%, and 1.5%, respectively, without statistically significant differences. The cumulative HR disease-free survival rates were 63.4%, 48%, and 69.2%, respectively (A vs. B, log-rank score 154.9 [<i>p</i> < 0.05]; B vs. C, 415 [<i>p</i> < 0.05]; A vs. C, 244 [<i>p</i> < 0.05]).</p><p><strong>Conclusions: </strong>A tailored intravesical instillation procedure may reduce BCG discontinuation and adverse effects.</p>","PeriodicalId":39147,"journal":{"name":"Current Urology","volume":"16 3","pages":"160-167"},"PeriodicalIF":0.9000,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/de/curr-urol-16-160.PMC9527929.pdf","citationCount":"0","resultStr":"{\"title\":\"How to reduce bacillus Calmette-Guérin discontinuation in patients with severe functional impairment.\",\"authors\":\"Luca Di Gianfrancesco, Mauro Ragonese, Massimiliano Foti, Giuseppe Palermo, Emilio Sacco, PierFrancesco Bassi, Marco Racioppi\",\"doi\":\"10.1097/CU9.0000000000000134\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Severe functional impairment is often considered a contraindication to intravesical therapy for nonmuscle-invasive bladder cancer (NMIBC). A tailored intravesical bacillus Calmette-Guérin (BCG) procedure was evaluated in high-risk (HR)-NMIBC patients with severe functional impairment.</p><p><strong>Materials and methods: </strong>Patients with a Katz Index score of 2 or less and an initial diagnosis of HR-NMIBC with atraumatic insertion of a Foley-type indwelling catheter, bladder emptying, and BCG instillation were prospectively treated; after 2 hours, the bladder was emptied and the catheter was removed (group A).After propensity score matching, 52 patients in group A were compared with that of 52 consecutive patients in group B using a retrospective database, with similar baseline/oncological characteristics and treated with standard intermittent catheterization. Moreover, groups A and B were compared with that of 130 consecutive patients (group C) retrospectively evaluated, with similar oncological characteristics but with a Katz Index score of 3 or greater and treated with standard intermittent catheterization.</p><p><strong>Results: </strong>The discontinuation rates were 11.5%, 35%, and 9% in groups A, B, and C, respectively (A vs. B, log-rank score 42.52 [<i>p</i> < 0.05]; B vs. C, 107.6 [<i>p</i> < 0.05]; A vs. C, 3.45 [<i>p</i> > 0.05]). The overall adverse event rates were 38.5%, 57.7%, and 39.2%, respectively (A vs. B, <i>p</i> = 0.04; B vs. C, 0.03; A vs. C, 0.92). The rates of severe adverse events were 1.9%, 1.9%, and 1.5%, respectively, without statistically significant differences. The cumulative HR disease-free survival rates were 63.4%, 48%, and 69.2%, respectively (A vs. B, log-rank score 154.9 [<i>p</i> < 0.05]; B vs. C, 415 [<i>p</i> < 0.05]; A vs. C, 244 [<i>p</i> < 0.05]).</p><p><strong>Conclusions: </strong>A tailored intravesical instillation procedure may reduce BCG discontinuation and adverse effects.</p>\",\"PeriodicalId\":39147,\"journal\":{\"name\":\"Current Urology\",\"volume\":\"16 3\",\"pages\":\"160-167\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2022-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/de/curr-urol-16-160.PMC9527929.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Urology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/CU9.0000000000000134\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/8/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Urology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/CU9.0000000000000134","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/8/27 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:严重的功能损害通常被认为是膀胱内治疗非肌肉侵袭性膀胱癌(NMIBC)的禁忌症。对具有严重功能障碍的高风险(HR)-NMIBC患者进行了量身定制的膀胱内卡介苗(BCG)治疗。材料和方法:对Katz指数为2分或更低且初步诊断为HR-NMIBC的患者进行前瞻性治疗,并采用foley型留置导尿管、膀胱排空和BCG灌注;2小时后,排空膀胱并拔除导管(A组)。倾向评分匹配后,使用回顾性数据库将A组52例患者与B组连续52例患者进行比较,这些患者具有相似的基线/肿瘤特征,并接受标准间歇性导尿治疗。此外,将A组和B组与回顾性评估的130例连续患者(C组)进行比较,这些患者具有相似的肿瘤特征,但Katz指数评分为3分或更高,并接受标准间歇置管治疗。结果:A、B、C组停药率分别为11.5%、35%、9% (A组vs. B组,log-rank评分42.52 [p < 0.05];B比C, 107.6 [p < 0.05];A对C, 3.45 [p > 0.05])。总不良事件发生率分别为38.5%、57.7%和39.2% (A vs. B, p = 0.04;B对C, 0.03;A对C, 0.92)。严重不良事件发生率分别为1.9%、1.9%和1.5%,差异无统计学意义。累积HR无病生存率分别为63.4%、48%和69.2% (A vs B, log-rank评分154.9 [p < 0.05];B vs. C, 415 [p < 0.05];A对C, 244 [p < 0.05])。结论:量身定制的膀胱内注射程序可减少卡介苗停药和不良反应。
How to reduce bacillus Calmette-Guérin discontinuation in patients with severe functional impairment.
Background: Severe functional impairment is often considered a contraindication to intravesical therapy for nonmuscle-invasive bladder cancer (NMIBC). A tailored intravesical bacillus Calmette-Guérin (BCG) procedure was evaluated in high-risk (HR)-NMIBC patients with severe functional impairment.
Materials and methods: Patients with a Katz Index score of 2 or less and an initial diagnosis of HR-NMIBC with atraumatic insertion of a Foley-type indwelling catheter, bladder emptying, and BCG instillation were prospectively treated; after 2 hours, the bladder was emptied and the catheter was removed (group A).After propensity score matching, 52 patients in group A were compared with that of 52 consecutive patients in group B using a retrospective database, with similar baseline/oncological characteristics and treated with standard intermittent catheterization. Moreover, groups A and B were compared with that of 130 consecutive patients (group C) retrospectively evaluated, with similar oncological characteristics but with a Katz Index score of 3 or greater and treated with standard intermittent catheterization.
Results: The discontinuation rates were 11.5%, 35%, and 9% in groups A, B, and C, respectively (A vs. B, log-rank score 42.52 [p < 0.05]; B vs. C, 107.6 [p < 0.05]; A vs. C, 3.45 [p > 0.05]). The overall adverse event rates were 38.5%, 57.7%, and 39.2%, respectively (A vs. B, p = 0.04; B vs. C, 0.03; A vs. C, 0.92). The rates of severe adverse events were 1.9%, 1.9%, and 1.5%, respectively, without statistically significant differences. The cumulative HR disease-free survival rates were 63.4%, 48%, and 69.2%, respectively (A vs. B, log-rank score 154.9 [p < 0.05]; B vs. C, 415 [p < 0.05]; A vs. C, 244 [p < 0.05]).
Conclusions: A tailored intravesical instillation procedure may reduce BCG discontinuation and adverse effects.