Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study
Objectives To assess bacillus Calmette–Guérin maintenance treatment schedule for non‐muscle invasive bladder cancer at 2 years, using one‐third of the full dose and fewer instillations every 3 months or 6 months. Methods This was a prospective, randomized, multicenter study. All patients had an inte...
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| Veröffentlicht in: | International journal of urology 2015-01, Vol.22 (1), p.53-60 |
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| creator | Pfister, Christian Kerkeni, Walid Rigaud, Jerome Le Gal, Sophie Saint, Fabien Colombel, Marc Guy, Laurent Wallerand, Herve Irani, Jacques Soulie, Michel |
| description | Objectives
To assess bacillus Calmette–Guérin maintenance treatment schedule for non‐muscle invasive bladder cancer at 2 years, using one‐third of the full dose and fewer instillations every 3 months or 6 months.
Methods
This was a prospective, randomized, multicenter study. All patients had an intermediate‐ or high‐risk non‐muscle invasive bladder cancer. They received three weekly instillations of one‐third dose bacillus Calmette–Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate‐specific antigen.
Results
No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette–Guérin tolerance was comparable – the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate‐specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.
Conclusion
One‐third dose maintenance bacillus Calmette–Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side‐effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate‐specific antigen levels do not appear to be useful in predicting bacillus Calmette–Guérin toxicity. |
| doi_str_mv | 10.1111/iju.12609 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_1652376991</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1652376991</sourcerecordid><originalsourceid>FETCH-LOGICAL-i3139-8c213eef3774a47aafcf2c8c54348822133eef293472f01cbc8f2a20be91a4083</originalsourceid><addsrcrecordid>eNo9UUluFDEUtRARaQILLoC8ZOPEU03sSCk0QVGCojRIbCy3-1vt4Krq2C5CnQhxDi6GeyDe-Om_4ct-CL1h9JTlc-bux1PGS9o8QzMmJSecSv4czWjDGlKzih-jlzHeU8oEZ_ULdMwLXpQ1EzP0-8JaZ7SZsO5XOA0egu4N4MHioQeS1i6ssB29x6shAl5q47wfI2617yAlIPPx75_getxp1yfod-a0zimbCcNPCBMWuBv6tI54CLg84Pf47nEgE-iAA8TRp7jduLi9IeftnEjc5ZEzkBMDjmlcTa_QkdU-wuvDfYIWHy_u2k_k6mZ-2X64Ik4wkR9rOBMAVlSV1LLS2hrLTW0KKWRd80xuWd4IWXFLmVma2nLN6RIapiWtxQl6t8_dhOFhhJhU56IB73UPwxgVKwsuqrJpWJa-PUjHZQcrtQmu02FS_z83C872gkfnYXriGVXb1lRuTe1aU5efFzuQHWTvcDHBryeHDj9UWYmqUN-u56qV51-_f6luVSv-AWjDmvo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1652376991</pqid></control><display><type>article</type><title>Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><creator>Pfister, Christian ; Kerkeni, Walid ; Rigaud, Jerome ; Le Gal, Sophie ; Saint, Fabien ; Colombel, Marc ; Guy, Laurent ; Wallerand, Herve ; Irani, Jacques ; Soulie, Michel</creator><creatorcontrib>Pfister, Christian ; Kerkeni, Walid ; Rigaud, Jerome ; Le Gal, Sophie ; Saint, Fabien ; Colombel, Marc ; Guy, Laurent ; Wallerand, Herve ; Irani, Jacques ; Soulie, Michel ; Cancer Committee of French Urological Association</creatorcontrib><description>Objectives
To assess bacillus Calmette–Guérin maintenance treatment schedule for non‐muscle invasive bladder cancer at 2 years, using one‐third of the full dose and fewer instillations every 3 months or 6 months.
Methods
This was a prospective, randomized, multicenter study. All patients had an intermediate‐ or high‐risk non‐muscle invasive bladder cancer. They received three weekly instillations of one‐third dose bacillus Calmette–Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate‐specific antigen.
Results
No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette–Guérin tolerance was comparable – the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate‐specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.
Conclusion
One‐third dose maintenance bacillus Calmette–Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side‐effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate‐specific antigen levels do not appear to be useful in predicting bacillus Calmette–Guérin toxicity.</description><identifier>ISSN: 0919-8172</identifier><identifier>EISSN: 1442-2042</identifier><identifier>DOI: 10.1111/iju.12609</identifier><identifier>PMID: 25256813</identifier><language>eng</language><publisher>Australia: Blackwell Publishing Ltd</publisher><subject>Administration, Intravesical ; Adult ; Aged ; Aged, 80 and over ; bacillus Calmette-Guérin ; BCG Vaccine - administration & dosage ; BCG Vaccine - adverse effects ; BCG Vaccine - therapeutic use ; bladder cancer ; Carcinoma, Transitional Cell - drug therapy ; Disease Progression ; Female ; Humans ; Immune Tolerance ; maintenance ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Prospective Studies ; Prostate-Specific Antigen ; Pyuria ; recurrence ; side-effects ; Treatment Outcome ; Urinary Bladder Neoplasms - drug therapy ; Urinary Bladder Neoplasms - pathology</subject><ispartof>International journal of urology, 2015-01, Vol.22 (1), p.53-60</ispartof><rights>2014 The Japanese Urological Association</rights><rights>2014 The Japanese Urological Association.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fiju.12609$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fiju.12609$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25256813$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pfister, Christian</creatorcontrib><creatorcontrib>Kerkeni, Walid</creatorcontrib><creatorcontrib>Rigaud, Jerome</creatorcontrib><creatorcontrib>Le Gal, Sophie</creatorcontrib><creatorcontrib>Saint, Fabien</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Guy, Laurent</creatorcontrib><creatorcontrib>Wallerand, Herve</creatorcontrib><creatorcontrib>Irani, Jacques</creatorcontrib><creatorcontrib>Soulie, Michel</creatorcontrib><creatorcontrib>Cancer Committee of French Urological Association</creatorcontrib><title>Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study</title><title>International journal of urology</title><addtitle>Int J Urol</addtitle><description>Objectives
To assess bacillus Calmette–Guérin maintenance treatment schedule for non‐muscle invasive bladder cancer at 2 years, using one‐third of the full dose and fewer instillations every 3 months or 6 months.
Methods
This was a prospective, randomized, multicenter study. All patients had an intermediate‐ or high‐risk non‐muscle invasive bladder cancer. They received three weekly instillations of one‐third dose bacillus Calmette–Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate‐specific antigen.
Results
No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette–Guérin tolerance was comparable – the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate‐specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.
Conclusion
One‐third dose maintenance bacillus Calmette–Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side‐effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate‐specific antigen levels do not appear to be useful in predicting bacillus Calmette–Guérin toxicity.</description><subject>Administration, Intravesical</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>bacillus Calmette-Guérin</subject><subject>BCG Vaccine - administration & dosage</subject><subject>BCG Vaccine - adverse effects</subject><subject>BCG Vaccine - therapeutic use</subject><subject>bladder cancer</subject><subject>Carcinoma, Transitional Cell - drug therapy</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Humans</subject><subject>Immune Tolerance</subject><subject>maintenance</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local</subject><subject>Prospective Studies</subject><subject>Prostate-Specific Antigen</subject><subject>Pyuria</subject><subject>recurrence</subject><subject>side-effects</subject><subject>Treatment Outcome</subject><subject>Urinary Bladder Neoplasms - drug therapy</subject><subject>Urinary Bladder Neoplasms - pathology</subject><issn>0919-8172</issn><issn>1442-2042</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9UUluFDEUtRARaQILLoC8ZOPEU03sSCk0QVGCojRIbCy3-1vt4Krq2C5CnQhxDi6GeyDe-Om_4ct-CL1h9JTlc-bux1PGS9o8QzMmJSecSv4czWjDGlKzih-jlzHeU8oEZ_ULdMwLXpQ1EzP0-8JaZ7SZsO5XOA0egu4N4MHioQeS1i6ssB29x6shAl5q47wfI2617yAlIPPx75_getxp1yfod-a0zimbCcNPCBMWuBv6tI54CLg84Pf47nEgE-iAA8TRp7jduLi9IeftnEjc5ZEzkBMDjmlcTa_QkdU-wuvDfYIWHy_u2k_k6mZ-2X64Ik4wkR9rOBMAVlSV1LLS2hrLTW0KKWRd80xuWd4IWXFLmVma2nLN6RIapiWtxQl6t8_dhOFhhJhU56IB73UPwxgVKwsuqrJpWJa-PUjHZQcrtQmu02FS_z83C872gkfnYXriGVXb1lRuTe1aU5efFzuQHWTvcDHBryeHDj9UWYmqUN-u56qV51-_f6luVSv-AWjDmvo</recordid><startdate>201501</startdate><enddate>201501</enddate><creator>Pfister, Christian</creator><creator>Kerkeni, Walid</creator><creator>Rigaud, Jerome</creator><creator>Le Gal, Sophie</creator><creator>Saint, Fabien</creator><creator>Colombel, Marc</creator><creator>Guy, Laurent</creator><creator>Wallerand, Herve</creator><creator>Irani, Jacques</creator><creator>Soulie, Michel</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201501</creationdate><title>Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study</title><author>Pfister, Christian ; Kerkeni, Walid ; Rigaud, Jerome ; Le Gal, Sophie ; Saint, Fabien ; Colombel, Marc ; Guy, Laurent ; Wallerand, Herve ; Irani, Jacques ; Soulie, Michel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i3139-8c213eef3774a47aafcf2c8c54348822133eef293472f01cbc8f2a20be91a4083</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Administration, Intravesical</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>bacillus Calmette-Guérin</topic><topic>BCG Vaccine - administration & dosage</topic><topic>BCG Vaccine - adverse effects</topic><topic>BCG Vaccine - therapeutic use</topic><topic>bladder cancer</topic><topic>Carcinoma, Transitional Cell - drug therapy</topic><topic>Disease Progression</topic><topic>Female</topic><topic>Humans</topic><topic>Immune Tolerance</topic><topic>maintenance</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local</topic><topic>Prospective Studies</topic><topic>Prostate-Specific Antigen</topic><topic>Pyuria</topic><topic>recurrence</topic><topic>side-effects</topic><topic>Treatment Outcome</topic><topic>Urinary Bladder Neoplasms - drug therapy</topic><topic>Urinary Bladder Neoplasms - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pfister, Christian</creatorcontrib><creatorcontrib>Kerkeni, Walid</creatorcontrib><creatorcontrib>Rigaud, Jerome</creatorcontrib><creatorcontrib>Le Gal, Sophie</creatorcontrib><creatorcontrib>Saint, Fabien</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Guy, Laurent</creatorcontrib><creatorcontrib>Wallerand, Herve</creatorcontrib><creatorcontrib>Irani, Jacques</creatorcontrib><creatorcontrib>Soulie, Michel</creatorcontrib><creatorcontrib>Cancer Committee of French Urological Association</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pfister, Christian</au><au>Kerkeni, Walid</au><au>Rigaud, Jerome</au><au>Le Gal, Sophie</au><au>Saint, Fabien</au><au>Colombel, Marc</au><au>Guy, Laurent</au><au>Wallerand, Herve</au><au>Irani, Jacques</au><au>Soulie, Michel</au><aucorp>Cancer Committee of French Urological Association</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study</atitle><jtitle>International journal of urology</jtitle><addtitle>Int J Urol</addtitle><date>2015-01</date><risdate>2015</risdate><volume>22</volume><issue>1</issue><spage>53</spage><epage>60</epage><pages>53-60</pages><issn>0919-8172</issn><eissn>1442-2042</eissn><abstract>Objectives
To assess bacillus Calmette–Guérin maintenance treatment schedule for non‐muscle invasive bladder cancer at 2 years, using one‐third of the full dose and fewer instillations every 3 months or 6 months.
Methods
This was a prospective, randomized, multicenter study. All patients had an intermediate‐ or high‐risk non‐muscle invasive bladder cancer. They received three weekly instillations of one‐third dose bacillus Calmette–Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate‐specific antigen.
Results
No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette–Guérin tolerance was comparable – the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate‐specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.
Conclusion
One‐third dose maintenance bacillus Calmette–Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side‐effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate‐specific antigen levels do not appear to be useful in predicting bacillus Calmette–Guérin toxicity.</abstract><cop>Australia</cop><pub>Blackwell Publishing Ltd</pub><pmid>25256813</pmid><doi>10.1111/iju.12609</doi><tpages>8</tpages></addata></record> |
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| ispartof | International journal of urology, 2015-01, Vol.22 (1), p.53-60 |
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| subjects | Administration, Intravesical Adult Aged Aged, 80 and over bacillus Calmette-Guérin BCG Vaccine - administration & dosage BCG Vaccine - adverse effects BCG Vaccine - therapeutic use bladder cancer Carcinoma, Transitional Cell - drug therapy Disease Progression Female Humans Immune Tolerance maintenance Male Middle Aged Neoplasm Recurrence, Local Prospective Studies Prostate-Specific Antigen Pyuria recurrence side-effects Treatment Outcome Urinary Bladder Neoplasms - drug therapy Urinary Bladder Neoplasms - pathology |
| title | Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: Two-year results of URO-BCG-4 multicenter study |
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