Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study
PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND M...
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| Veröffentlicht in: | Journal of clinical oncology 2021-01, Vol.39 (3), p.202-214 |
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| creator | Catto, James W. F. Gordon, Kathryn Collinson, Michelle Poad, Heather Twiddy, Maureen Johnson, Mark Jain, Sunjay Chahal, Rohit Simms, Matt Dooldeniya, Mohantha Bell, Richard Koenig, Phillip Conroy, Samantha Goodwin, Louise Noon, Aidan P. Croft, Julie Brown, Julia M. |
| description | PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible.
MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned.
RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months.
CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL. (C) 2020 by American Society of Clinical Oncology |
| doi_str_mv | 10.1200/JCO.20.01665 |
| format | Article |
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MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned.
RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months.
CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL. (C) 2020 by American Society of Clinical Oncology</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.20.01665</identifier><identifier>PMID: 33332191</identifier><language>eng</language><publisher>PHILADELPHIA: Lippincott Williams & Wilkins</publisher><subject>Administration, Intravesical ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; BCG Vaccine - administration & dosage ; BCG Vaccine - adverse effects ; Cystectomy - adverse effects ; Feasibility Studies ; Female ; Humans ; Life Sciences & Biomedicine ; Male ; Neoplasm Grading ; Neoplasm Invasiveness ; Oncology ; ORIGINAL REPORTS ; Prospective Studies ; Science & Technology ; Time Factors ; Treatment Outcome ; United Kingdom ; Urinary Bladder Neoplasms - mortality ; Urinary Bladder Neoplasms - pathology ; Urinary Bladder Neoplasms - therapy</subject><ispartof>Journal of clinical oncology, 2021-01, Vol.39 (3), p.202-214</ispartof><rights>2020 by American Society of Clinical Oncology 2020 American Society of Clinical Oncology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>63</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000635366300004</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c427t-52095868c2c18841d3e648cd466db4c60bf7c4ebc5598dbfb97d36e56c6c3f7b3</citedby><cites>FETCH-LOGICAL-c427t-52095868c2c18841d3e648cd466db4c60bf7c4ebc5598dbfb97d36e56c6c3f7b3</cites><orcidid>0000-0001-7167-4908 ; 0000-0002-3794-1598 ; 0000-0001-7586-3394</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,3730,27929,27930,39263</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33332191$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Catto, James W. F.</creatorcontrib><creatorcontrib>Gordon, Kathryn</creatorcontrib><creatorcontrib>Collinson, Michelle</creatorcontrib><creatorcontrib>Poad, Heather</creatorcontrib><creatorcontrib>Twiddy, Maureen</creatorcontrib><creatorcontrib>Johnson, Mark</creatorcontrib><creatorcontrib>Jain, Sunjay</creatorcontrib><creatorcontrib>Chahal, Rohit</creatorcontrib><creatorcontrib>Simms, Matt</creatorcontrib><creatorcontrib>Dooldeniya, Mohantha</creatorcontrib><creatorcontrib>Bell, Richard</creatorcontrib><creatorcontrib>Koenig, Phillip</creatorcontrib><creatorcontrib>Conroy, Samantha</creatorcontrib><creatorcontrib>Goodwin, Louise</creatorcontrib><creatorcontrib>Noon, Aidan P.</creatorcontrib><creatorcontrib>Croft, Julie</creatorcontrib><creatorcontrib>Brown, Julia M.</creatorcontrib><creatorcontrib>BRAVO Study Grp</creatorcontrib><creatorcontrib>BRAVO study group</creatorcontrib><creatorcontrib>on behalf of the BRAVO study group</creatorcontrib><title>Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study</title><title>Journal of clinical oncology</title><addtitle>J CLIN ONCOL</addtitle><addtitle>J Clin Oncol</addtitle><description>PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible.
MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned.
RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months.
CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL. (C) 2020 by American Society of Clinical Oncology</description><subject>Administration, Intravesical</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>BCG Vaccine - administration & dosage</subject><subject>BCG Vaccine - adverse effects</subject><subject>Cystectomy - adverse effects</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Humans</subject><subject>Life Sciences & Biomedicine</subject><subject>Male</subject><subject>Neoplasm Grading</subject><subject>Neoplasm Invasiveness</subject><subject>Oncology</subject><subject>ORIGINAL REPORTS</subject><subject>Prospective Studies</subject><subject>Science & Technology</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><subject>Urinary Bladder Neoplasms - mortality</subject><subject>Urinary Bladder Neoplasms - pathology</subject><subject>Urinary Bladder Neoplasms - therapy</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>EIF</sourceid><recordid>eNqNkU2P0zAQhiMEYpeFG2fkIxKk2PFHUg5IbUS7i1ZUKh_iZjn2pDUk8WI7ReUH8TvxtksFN3yZV5rH74zmzbKnBE9IgfGrd_VqUuAJJkLwe9k54UWZlyXn97NzXNIiJxX9cpY9CuErxoRVlD_Mzmh6BZmS8-zXWhmrVYfqfYigo-v3aLZRdggRXQ3Rqx2EQ39eL1HrPLq0m22-tuHbUS29MoDeu6Efg-4g_dmpYHeA5p0yBjyq1aDBv0ZrCGMXA1p416O4BbRWg3G9_QkG1S5Ncl2X5Hw9-7zKF5BMGtvZuEcf4mj2j7MHreoCPLmrF9mnxduP9WV-vVpe1bPrXLOijDkv8JRXotKFJlXFiKEgWKUNE8I0TAvctKVm0GjOp5Vp2mZaGiqACy00bcuGXmRvjr43Y9OD0XB7gk7eeNsrv5dOWflvZ7BbuXE7WeGyYpglg-d3Bt59HyFE2dugoevUAG4MsmAlYXzKGUnoyyOqvQvBQ3saQ7C8jVamaGWB5SHahD_7e7UT_CfLBLw4Aj-gcW3QFtLlTxjGWFBOhaBJHRat_p-ubVTRuqF24xDpbxf2wqc</recordid><startdate>20210120</startdate><enddate>20210120</enddate><creator>Catto, James W. F.</creator><creator>Gordon, Kathryn</creator><creator>Collinson, Michelle</creator><creator>Poad, Heather</creator><creator>Twiddy, Maureen</creator><creator>Johnson, Mark</creator><creator>Jain, Sunjay</creator><creator>Chahal, Rohit</creator><creator>Simms, Matt</creator><creator>Dooldeniya, Mohantha</creator><creator>Bell, Richard</creator><creator>Koenig, Phillip</creator><creator>Conroy, Samantha</creator><creator>Goodwin, Louise</creator><creator>Noon, Aidan P.</creator><creator>Croft, Julie</creator><creator>Brown, Julia M.</creator><general>Lippincott Williams & Wilkins</general><general>American Society of Clinical Oncology</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><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><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7167-4908</orcidid><orcidid>https://orcid.org/0000-0002-3794-1598</orcidid><orcidid>https://orcid.org/0000-0001-7586-3394</orcidid></search><sort><creationdate>20210120</creationdate><title>Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study</title><author>Catto, James W. F. ; Gordon, Kathryn ; Collinson, Michelle ; Poad, Heather ; Twiddy, Maureen ; Johnson, Mark ; Jain, Sunjay ; Chahal, Rohit ; Simms, Matt ; Dooldeniya, Mohantha ; Bell, Richard ; Koenig, Phillip ; Conroy, Samantha ; Goodwin, Louise ; Noon, Aidan P. ; Croft, Julie ; Brown, Julia M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c427t-52095868c2c18841d3e648cd466db4c60bf7c4ebc5598dbfb97d36e56c6c3f7b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Administration, Intravesical</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>BCG Vaccine - administration & dosage</topic><topic>BCG Vaccine - adverse effects</topic><topic>Cystectomy - adverse effects</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Humans</topic><topic>Life Sciences & Biomedicine</topic><topic>Male</topic><topic>Neoplasm Grading</topic><topic>Neoplasm Invasiveness</topic><topic>Oncology</topic><topic>ORIGINAL REPORTS</topic><topic>Prospective Studies</topic><topic>Science & Technology</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><topic>Urinary Bladder Neoplasms - mortality</topic><topic>Urinary Bladder Neoplasms - pathology</topic><topic>Urinary Bladder Neoplasms - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Catto, James W. F.</creatorcontrib><creatorcontrib>Gordon, Kathryn</creatorcontrib><creatorcontrib>Collinson, Michelle</creatorcontrib><creatorcontrib>Poad, Heather</creatorcontrib><creatorcontrib>Twiddy, Maureen</creatorcontrib><creatorcontrib>Johnson, Mark</creatorcontrib><creatorcontrib>Jain, Sunjay</creatorcontrib><creatorcontrib>Chahal, Rohit</creatorcontrib><creatorcontrib>Simms, Matt</creatorcontrib><creatorcontrib>Dooldeniya, Mohantha</creatorcontrib><creatorcontrib>Bell, Richard</creatorcontrib><creatorcontrib>Koenig, Phillip</creatorcontrib><creatorcontrib>Conroy, Samantha</creatorcontrib><creatorcontrib>Goodwin, Louise</creatorcontrib><creatorcontrib>Noon, Aidan P.</creatorcontrib><creatorcontrib>Croft, Julie</creatorcontrib><creatorcontrib>Brown, Julia M.</creatorcontrib><creatorcontrib>BRAVO Study Grp</creatorcontrib><creatorcontrib>BRAVO study group</creatorcontrib><creatorcontrib>on behalf of the BRAVO study group</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Catto, James W. F.</au><au>Gordon, Kathryn</au><au>Collinson, Michelle</au><au>Poad, Heather</au><au>Twiddy, Maureen</au><au>Johnson, Mark</au><au>Jain, Sunjay</au><au>Chahal, Rohit</au><au>Simms, Matt</au><au>Dooldeniya, Mohantha</au><au>Bell, Richard</au><au>Koenig, Phillip</au><au>Conroy, Samantha</au><au>Goodwin, Louise</au><au>Noon, Aidan P.</au><au>Croft, Julie</au><au>Brown, Julia M.</au><aucorp>BRAVO Study Grp</aucorp><aucorp>BRAVO study group</aucorp><aucorp>on behalf of the BRAVO study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study</atitle><jtitle>Journal of clinical oncology</jtitle><stitle>J CLIN ONCOL</stitle><addtitle>J Clin Oncol</addtitle><date>2021-01-20</date><risdate>2021</risdate><volume>39</volume><issue>3</issue><spage>202</spage><epage>214</epage><pages>202-214</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible.
MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned.
RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months.
CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL. (C) 2020 by American Society of Clinical Oncology</abstract><cop>PHILADELPHIA</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33332191</pmid><doi>10.1200/JCO.20.01665</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0001-7167-4908</orcidid><orcidid>https://orcid.org/0000-0002-3794-1598</orcidid><orcidid>https://orcid.org/0000-0001-7586-3394</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Intravesical Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects BCG Vaccine - administration & dosage BCG Vaccine - adverse effects Cystectomy - adverse effects Feasibility Studies Female Humans Life Sciences & Biomedicine Male Neoplasm Grading Neoplasm Invasiveness Oncology ORIGINAL REPORTS Prospective Studies Science & Technology Time Factors Treatment Outcome United Kingdom Urinary Bladder Neoplasms - mortality Urinary Bladder Neoplasms - pathology Urinary Bladder Neoplasms - therapy |
| title | Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study |
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