Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer
To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration. All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at...
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| Veröffentlicht in: | Urology (Ridgewood, N.J.) N.J.), 2021-10, Vol.156, p.191-198 |
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| creator | Kuperus, Joshua M. Busman, Ross D. Kuipers, Susan K. Broekhuizen, Helen T. Noyes, Sabrina L. Brede, Christopher M. Tobert, Conrad M. Lane, Brian R. |
| description | To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration.
All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at our institution were surveyed before repeat instillation. Survey questions recorded IVT retention times and the duration and severity of the following side effects: bladder symptoms, fatigue, body aches, hematuria, fever, chills, and other. All responses were collected and quantified in a de-identified, password-protected database. Statistical analysis was performed using SAS JMP 13.
Of 592 surveys completed, symptoms of any kind were reported on 463 surveys (78%) with the most common symptoms including bladder symptoms (59%), fatigue (52%), body aches (26%), and hematuria (18%). Patients were able to hold full-dose BCG, reduced-dose BCG, and gemcitabine for the protocol-specified duration 87%, 95%, and 71% of the time (P |
| doi_str_mv | 10.1016/j.urology.2021.04.062 |
| format | Article |
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All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at our institution were surveyed before repeat instillation. Survey questions recorded IVT retention times and the duration and severity of the following side effects: bladder symptoms, fatigue, body aches, hematuria, fever, chills, and other. All responses were collected and quantified in a de-identified, password-protected database. Statistical analysis was performed using SAS JMP 13.
Of 592 surveys completed, symptoms of any kind were reported on 463 surveys (78%) with the most common symptoms including bladder symptoms (59%), fatigue (52%), body aches (26%), and hematuria (18%). Patients were able to hold full-dose BCG, reduced-dose BCG, and gemcitabine for the protocol-specified duration 87%, 95%, and 71% of the time (P <0.05). The prevalence, severity, and duration of body aches were highest with gemcitabine (P <0.05) while the prevalence and duration of hematuria were higher with BCG (P <0.05). Reduced-dose BCG had the lowest prevalence, severity, and duration of fatigue (P <0.05).
Significant differences in the side effects and tolerability of full-dose BCG, reduced-dose BCG, and gemcitabine were demonstrated using this novel survey, and these differences are of value for informing IVT selection. Evaluation of IVTs other than gemcitabine and BCG will further inform selection of therapies for NMIBC.</description><identifier>ISSN: 0090-4295</identifier><identifier>EISSN: 1527-9995</identifier><identifier>DOI: 10.1016/j.urology.2021.04.062</identifier><identifier>PMID: 34217763</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject><![CDATA[Adjuvants, Immunologic - administration & dosage ; Adjuvants, Immunologic - adverse effects ; Administration, Intravesical ; Aged ; Antimetabolites, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - adverse effects ; BCG Vaccine - administration & dosage ; BCG Vaccine - adverse effects ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Dose-Response Relationship, Drug ; Drug Monitoring - methods ; Drug Monitoring - statistics & numerical data ; Drug Tapering - methods ; Drug-Related Side Effects and Adverse Reactions - classification ; Drug-Related Side Effects and Adverse Reactions - diagnosis ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - etiology ; Female ; Humans ; Male ; Neoplasm Invasiveness ; Neoplasm Staging ; Patient Reported Outcome Measures ; Prevalence ; Symptom Assessment - methods ; Symptom Assessment - statistics & numerical data ; Urinary Bladder Neoplasms - drug therapy ; Urinary Bladder Neoplasms - pathology]]></subject><ispartof>Urology (Ridgewood, N.J.), 2021-10, Vol.156, p.191-198</ispartof><rights>2021 Elsevier Inc.</rights><rights>Copyright © 2021 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-3ac45ee39448670232f723e3585302ce3f64853cccb4fca6091d9ecbe00bcb833</citedby><cites>FETCH-LOGICAL-c365t-3ac45ee39448670232f723e3585302ce3f64853cccb4fca6091d9ecbe00bcb833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.urology.2021.04.062$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34217763$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kuperus, Joshua M.</creatorcontrib><creatorcontrib>Busman, Ross D.</creatorcontrib><creatorcontrib>Kuipers, Susan K.</creatorcontrib><creatorcontrib>Broekhuizen, Helen T.</creatorcontrib><creatorcontrib>Noyes, Sabrina L.</creatorcontrib><creatorcontrib>Brede, Christopher M.</creatorcontrib><creatorcontrib>Tobert, Conrad M.</creatorcontrib><creatorcontrib>Lane, Brian R.</creatorcontrib><title>Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer</title><title>Urology (Ridgewood, N.J.)</title><addtitle>Urology</addtitle><description>To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration.
All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at our institution were surveyed before repeat instillation. Survey questions recorded IVT retention times and the duration and severity of the following side effects: bladder symptoms, fatigue, body aches, hematuria, fever, chills, and other. All responses were collected and quantified in a de-identified, password-protected database. Statistical analysis was performed using SAS JMP 13.
Of 592 surveys completed, symptoms of any kind were reported on 463 surveys (78%) with the most common symptoms including bladder symptoms (59%), fatigue (52%), body aches (26%), and hematuria (18%). Patients were able to hold full-dose BCG, reduced-dose BCG, and gemcitabine for the protocol-specified duration 87%, 95%, and 71% of the time (P <0.05). The prevalence, severity, and duration of body aches were highest with gemcitabine (P <0.05) while the prevalence and duration of hematuria were higher with BCG (P <0.05). Reduced-dose BCG had the lowest prevalence, severity, and duration of fatigue (P <0.05).
Significant differences in the side effects and tolerability of full-dose BCG, reduced-dose BCG, and gemcitabine were demonstrated using this novel survey, and these differences are of value for informing IVT selection. Evaluation of IVTs other than gemcitabine and BCG will further inform selection of therapies for NMIBC.</description><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Adjuvants, Immunologic - adverse effects</subject><subject>Administration, Intravesical</subject><subject>Aged</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>BCG Vaccine - administration & dosage</subject><subject>BCG Vaccine - adverse effects</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Monitoring - methods</subject><subject>Drug Monitoring - statistics & numerical data</subject><subject>Drug Tapering - methods</subject><subject>Drug-Related Side Effects and Adverse Reactions - classification</subject><subject>Drug-Related Side Effects and Adverse Reactions - diagnosis</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Neoplasm Invasiveness</subject><subject>Neoplasm Staging</subject><subject>Patient Reported Outcome Measures</subject><subject>Prevalence</subject><subject>Symptom Assessment - methods</subject><subject>Symptom Assessment - statistics & numerical data</subject><subject>Urinary Bladder Neoplasms - drug therapy</subject><subject>Urinary Bladder Neoplasms - pathology</subject><issn>0090-4295</issn><issn>1527-9995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcGO0zAURS0EYsrAJ4C8ZEGCYztOvUI0zJSRBpBgWFuO_YJcOXaxk6L-Dl-KZ1rYsnpe3Hueng9CLxtSN6QRb3f1kqKPP441JbSpCa-JoI_QqmlpV0kp28doRYgkFaeyvUDPct4RQoQQ3VN0wThtuk6wFfrdx2mvk8sx4Djib84CvhpHMHPGOlh8Fz0kPTjv5iPewPwLIOCbMCd9gOyM9nijjfN-ybjXfoJ5hmq7QHLhDf4KdjFgqw8xA9702wfgFibj5kIMgMeY8OcYqk9LNh4K9qCzO5Ss19ZCKsRgID1HT0btM7w4z0v0_frqrv9Y3X7Z3vTvbyvDRDtXTBveAjDJ-Vp0hDI6dpQBa9ctI9QAGwUvT2PMwEejBZGNlWAGIGQww5qxS_T6xN2n-HOBPKvJZQPe6wBxyYq2pS9l1_ESbU9Rk2LOCUa1T27S6agaou71qJ0661H3ehThqugpvVfnFcswgf3X-uujBN6dAlAOPThIKhsH5ResS8WJstH9Z8Uf6ayl1w</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Kuperus, Joshua M.</creator><creator>Busman, Ross D.</creator><creator>Kuipers, Susan K.</creator><creator>Broekhuizen, Helen T.</creator><creator>Noyes, Sabrina L.</creator><creator>Brede, Christopher M.</creator><creator>Tobert, Conrad M.</creator><creator>Lane, Brian R.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202110</creationdate><title>Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer</title><author>Kuperus, Joshua M. ; Busman, Ross D. ; Kuipers, Susan K. ; Broekhuizen, Helen T. ; Noyes, Sabrina L. ; Brede, Christopher M. ; Tobert, Conrad M. ; Lane, Brian R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c365t-3ac45ee39448670232f723e3585302ce3f64853cccb4fca6091d9ecbe00bcb833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adjuvants, Immunologic - administration & dosage</topic><topic>Adjuvants, Immunologic - adverse effects</topic><topic>Administration, Intravesical</topic><topic>Aged</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>BCG Vaccine - administration & dosage</topic><topic>BCG Vaccine - adverse effects</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Monitoring - methods</topic><topic>Drug Monitoring - statistics & numerical data</topic><topic>Drug Tapering - methods</topic><topic>Drug-Related Side Effects and Adverse Reactions - classification</topic><topic>Drug-Related Side Effects and Adverse Reactions - diagnosis</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Neoplasm Invasiveness</topic><topic>Neoplasm Staging</topic><topic>Patient Reported Outcome Measures</topic><topic>Prevalence</topic><topic>Symptom Assessment - methods</topic><topic>Symptom Assessment - statistics & numerical data</topic><topic>Urinary Bladder Neoplasms - drug therapy</topic><topic>Urinary Bladder Neoplasms - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kuperus, Joshua M.</creatorcontrib><creatorcontrib>Busman, Ross D.</creatorcontrib><creatorcontrib>Kuipers, Susan K.</creatorcontrib><creatorcontrib>Broekhuizen, Helen T.</creatorcontrib><creatorcontrib>Noyes, Sabrina L.</creatorcontrib><creatorcontrib>Brede, Christopher M.</creatorcontrib><creatorcontrib>Tobert, Conrad M.</creatorcontrib><creatorcontrib>Lane, Brian R.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Urology (Ridgewood, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kuperus, Joshua M.</au><au>Busman, Ross D.</au><au>Kuipers, Susan K.</au><au>Broekhuizen, Helen T.</au><au>Noyes, Sabrina L.</au><au>Brede, Christopher M.</au><au>Tobert, Conrad M.</au><au>Lane, Brian R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer</atitle><jtitle>Urology (Ridgewood, N.J.)</jtitle><addtitle>Urology</addtitle><date>2021-10</date><risdate>2021</risdate><volume>156</volume><spage>191</spage><epage>198</epage><pages>191-198</pages><issn>0090-4295</issn><eissn>1527-9995</eissn><abstract>To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration.
All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at our institution were surveyed before repeat instillation. Survey questions recorded IVT retention times and the duration and severity of the following side effects: bladder symptoms, fatigue, body aches, hematuria, fever, chills, and other. All responses were collected and quantified in a de-identified, password-protected database. Statistical analysis was performed using SAS JMP 13.
Of 592 surveys completed, symptoms of any kind were reported on 463 surveys (78%) with the most common symptoms including bladder symptoms (59%), fatigue (52%), body aches (26%), and hematuria (18%). Patients were able to hold full-dose BCG, reduced-dose BCG, and gemcitabine for the protocol-specified duration 87%, 95%, and 71% of the time (P <0.05). The prevalence, severity, and duration of body aches were highest with gemcitabine (P <0.05) while the prevalence and duration of hematuria were higher with BCG (P <0.05). Reduced-dose BCG had the lowest prevalence, severity, and duration of fatigue (P <0.05).
Significant differences in the side effects and tolerability of full-dose BCG, reduced-dose BCG, and gemcitabine were demonstrated using this novel survey, and these differences are of value for informing IVT selection. Evaluation of IVTs other than gemcitabine and BCG will further inform selection of therapies for NMIBC.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34217763</pmid><doi>10.1016/j.urology.2021.04.062</doi><tpages>8</tpages></addata></record> |
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| ispartof | Urology (Ridgewood, N.J.), 2021-10, Vol.156, p.191-198 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - adverse effects Administration, Intravesical Aged Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects BCG Vaccine - administration & dosage BCG Vaccine - adverse effects Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Dose-Response Relationship, Drug Drug Monitoring - methods Drug Monitoring - statistics & numerical data Drug Tapering - methods Drug-Related Side Effects and Adverse Reactions - classification Drug-Related Side Effects and Adverse Reactions - diagnosis Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Female Humans Male Neoplasm Invasiveness Neoplasm Staging Patient Reported Outcome Measures Prevalence Symptom Assessment - methods Symptom Assessment - statistics & numerical data Urinary Bladder Neoplasms - drug therapy Urinary Bladder Neoplasms - pathology |
| title | Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer |
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