María Teresa Melgarejo Segura, Ana Morales Martínez, Yaiza Yáñez Castillo, Miguel Ángel Arrabal Polo, Francisco Gutiérrez Tejero, Manuel Pareja Vílchez, Miguel Arrabal Martín
{"title":"使用丝裂霉素 C 和卡介苗治疗非肌层浸润性膀胱癌的电动力给药化疗。","authors":"María Teresa Melgarejo Segura, Ana Morales Martínez, Yaiza Yáñez Castillo, Miguel Ángel Arrabal Polo, Francisco Gutiérrez Tejero, Manuel Pareja Vílchez, Miguel Arrabal Martín","doi":"10.3233/BLC-230042","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to classical Bacillus Calmette Guérin (BCG) treatment.</p><p><strong>Objective: </strong>To compare the efficacy of mitomycin C applied with the electromotive drug delivery device (MMC-EMDA) versus BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ (CIS).</p><p><strong>Methods: </strong>Prospective non-randomized study in which 47 patients received MMC-EMDA (40 mg of MMC diluted in 50 mg of distilled water at 20 mA for 30 min. Regimen of 6 weekly and then 6 monthly instillations) and 48 patients received BCG (50 mg of OncoCITE® diluted in 50 ml of normal saline for 60 min. Regimen of 6 weekly instillations and then 3 weekly instillations at months 3, 6 and 12). The primary endpoint was the recurrence-free rate (RFR) at 24 months. Secondary endpoints were time to recurrence and progression-free rate (PFR) at 24 months follow-up.</p><p><strong>Results: </strong>Baseline patient assessment and mean follow-up time were similar in both groups (MMC-EMDA group: 26.4 months; BCG group: 28.4 months (<i>p</i> = 0.44)). The RFR at 24 months was 80.9% for the MMC-EMDA group and 77.1% for the BCG group (<i>p</i> = 0.969). The mean time to recurrence was 12.5 months in the MMC-EMDA group and 14 months in the BCG group (<i>p</i> = 0.681). At 24 months, PFR was 97.9% in the MMC-EMDA group and 93.8% in the BCG group (<i>p</i> = 0.419).</p><p><strong>Conclusions: </strong>No differences were found between MMC-EMDA and BCG treatments in patients with high-risk and intermediate-risk NMIBC without CIS.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"1 1","pages":"159-166"},"PeriodicalIF":1.0000,"publicationDate":"2023-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181766/pdf/","citationCount":"0","resultStr":"{\"title\":\"Electromotive Drug Administration Chemotherapy with Mitomycin C Versus Bacillus Calmette-Guerin for the Treatment of Non-Muscle Invasive Bladder Cancer.\",\"authors\":\"María Teresa Melgarejo Segura, Ana Morales Martínez, Yaiza Yáñez Castillo, Miguel Ángel Arrabal Polo, Francisco Gutiérrez Tejero, Manuel Pareja Vílchez, Miguel Arrabal Martín\",\"doi\":\"10.3233/BLC-230042\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to classical Bacillus Calmette Guérin (BCG) treatment.</p><p><strong>Objective: </strong>To compare the efficacy of mitomycin C applied with the electromotive drug delivery device (MMC-EMDA) versus BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ (CIS).</p><p><strong>Methods: </strong>Prospective non-randomized study in which 47 patients received MMC-EMDA (40 mg of MMC diluted in 50 mg of distilled water at 20 mA for 30 min. Regimen of 6 weekly and then 6 monthly instillations) and 48 patients received BCG (50 mg of OncoCITE® diluted in 50 ml of normal saline for 60 min. Regimen of 6 weekly instillations and then 3 weekly instillations at months 3, 6 and 12). The primary endpoint was the recurrence-free rate (RFR) at 24 months. Secondary endpoints were time to recurrence and progression-free rate (PFR) at 24 months follow-up.</p><p><strong>Results: </strong>Baseline patient assessment and mean follow-up time were similar in both groups (MMC-EMDA group: 26.4 months; BCG group: 28.4 months (<i>p</i> = 0.44)). The RFR at 24 months was 80.9% for the MMC-EMDA group and 77.1% for the BCG group (<i>p</i> = 0.969). The mean time to recurrence was 12.5 months in the MMC-EMDA group and 14 months in the BCG group (<i>p</i> = 0.681). At 24 months, PFR was 97.9% in the MMC-EMDA group and 93.8% in the BCG group (<i>p</i> = 0.419).</p><p><strong>Conclusions: </strong>No differences were found between MMC-EMDA and BCG treatments in patients with high-risk and intermediate-risk NMIBC without CIS.</p>\",\"PeriodicalId\":54217,\"journal\":{\"name\":\"Bladder Cancer\",\"volume\":\"1 1\",\"pages\":\"159-166\"},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2023-06-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181766/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bladder Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3233/BLC-230042\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bladder Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3233/BLC-230042","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
Electromotive Drug Administration Chemotherapy with Mitomycin C Versus Bacillus Calmette-Guerin for the Treatment of Non-Muscle Invasive Bladder Cancer.
Background: Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to classical Bacillus Calmette Guérin (BCG) treatment.
Objective: To compare the efficacy of mitomycin C applied with the electromotive drug delivery device (MMC-EMDA) versus BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ (CIS).
Methods: Prospective non-randomized study in which 47 patients received MMC-EMDA (40 mg of MMC diluted in 50 mg of distilled water at 20 mA for 30 min. Regimen of 6 weekly and then 6 monthly instillations) and 48 patients received BCG (50 mg of OncoCITE® diluted in 50 ml of normal saline for 60 min. Regimen of 6 weekly instillations and then 3 weekly instillations at months 3, 6 and 12). The primary endpoint was the recurrence-free rate (RFR) at 24 months. Secondary endpoints were time to recurrence and progression-free rate (PFR) at 24 months follow-up.
Results: Baseline patient assessment and mean follow-up time were similar in both groups (MMC-EMDA group: 26.4 months; BCG group: 28.4 months (p = 0.44)). The RFR at 24 months was 80.9% for the MMC-EMDA group and 77.1% for the BCG group (p = 0.969). The mean time to recurrence was 12.5 months in the MMC-EMDA group and 14 months in the BCG group (p = 0.681). At 24 months, PFR was 97.9% in the MMC-EMDA group and 93.8% in the BCG group (p = 0.419).
Conclusions: No differences were found between MMC-EMDA and BCG treatments in patients with high-risk and intermediate-risk NMIBC without CIS.
期刊介绍：
Bladder Cancer is an international multidisciplinary journal to facilitate progress in understanding the epidemiology/etiology, genetics, molecular correlates, pathogenesis, pharmacology, ethics, patient advocacy and survivorship, diagnosis and treatment of tumors of the bladder and upper urinary tract. The journal publishes research reports, reviews, short communications, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research in basic science, translational research and clinical medicine that expedites our fundamental understanding and improves treatment of tumors of the bladder and upper urinary tract.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
