Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial
Objectives To compare the urinary pH, recurrence‐free survival (RFS), and safety of adjuvant intravesical therapy in patients with non‐muscle‐invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara‐C) therapy. Patients and Methods A total of 165 patien...
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| Veröffentlicht in: | BJU international 2022-04, Vol.129 (4), p.534-541 |
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| creator | Miyata, Yasuyoshi Tsurusaki, Toshifumi Hayashida, Yasushi Imasato, Yushi Takehara, Kosuke Aoki, Daiyu Nishikido, Masaharu Watanabe, Junichi Mitsunari, Kensuke Matsuo, Tomohiro Ohba, Kojiro Taniguchi, Keisuke Sakai, Hideki |
| description | Objectives
To compare the urinary pH, recurrence‐free survival (RFS), and safety of adjuvant intravesical therapy in patients with non‐muscle‐invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara‐C) therapy.
Patients and Methods
A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara‐C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.
Results
A total of 81 and 87 patients were randomised into the MMC and MMC + Ara‐C groups, respectively. Overall, the RFS in the MMC + Ara‐C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate‐risk NMIBC, but not in those with high‐risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara‐C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P 7.0 in the MMC and MMC + Ara‐C groups was 6.3% and 26.7%, respectively (P |
| doi_str_mv | 10.1111/bju.15571 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9290455</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2560830268</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3581-c8e6f85ec0b8a903acc3a988343dcc168fcd25f1c3a19625166237fb5bea4e8d3</originalsourceid><addsrcrecordid>eNp1kU1rFTEUhoNYbK0u_AMScNMit00mH824EPRiP6TFjQV3IZOc0VwySZvMXLm7brvzN_aXmPa2RQUDIS8nD2_OyYvQK0r2aF373WLao0Ic0Cdoi3LJZ5ySb08fNGnlJnpeyoKQWpDiGdpknCnGFN1C1ydxzGYJxVsT8ODHNKysj3iOd87O5rvYRIeruLm6flu3XY2p-AjYZNP5WLUD3KeMY4o3V7-GqdgAVfi4NMUvAXfBOAcZWxMt5HfY4Fwd0-ALOGyDj3fPjtmb8AJt9CYUeHl_bqPzw09f58ez0y9HJ_MPpzPLhKIzq0D2SoAlnTItYcZaZlql6kjOWipVb10jelqrtJWNoFI27KDvRAeGg3JsG71f-15M3QDOwu0HBH2R_WDySifj9d830f_Q39NSt01LuBDVYOfeIKfLCcqo6zgWQjAR0lR0IyRRjDRSVfTNP-giTTnW8XQjOW-4YJJWandN2ZxKydA_NkOJvg1Y14D1XcCVff1n94_kQ6IV2F8DP32A1f-d9MfP52vL3_s0tYI</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2644245361</pqid></control><display><type>article</type><title>Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Miyata, Yasuyoshi ; Tsurusaki, Toshifumi ; Hayashida, Yasushi ; Imasato, Yushi ; Takehara, Kosuke ; Aoki, Daiyu ; Nishikido, Masaharu ; Watanabe, Junichi ; Mitsunari, Kensuke ; Matsuo, Tomohiro ; Ohba, Kojiro ; Taniguchi, Keisuke ; Sakai, Hideki</creator><creatorcontrib>Miyata, Yasuyoshi ; Tsurusaki, Toshifumi ; Hayashida, Yasushi ; Imasato, Yushi ; Takehara, Kosuke ; Aoki, Daiyu ; Nishikido, Masaharu ; Watanabe, Junichi ; Mitsunari, Kensuke ; Matsuo, Tomohiro ; Ohba, Kojiro ; Taniguchi, Keisuke ; Sakai, Hideki ; Nagasaki University Urological Oncology Research Group ; the Nagasaki University Urological Oncology Research Group</creatorcontrib><description>Objectives
To compare the urinary pH, recurrence‐free survival (RFS), and safety of adjuvant intravesical therapy in patients with non‐muscle‐invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara‐C) therapy.
Patients and Methods
A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara‐C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.
Results
A total of 81 and 87 patients were randomised into the MMC and MMC + Ara‐C groups, respectively. Overall, the RFS in the MMC + Ara‐C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate‐risk NMIBC, but not in those with high‐risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara‐C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara‐C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18–0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara‐C groups, respectively, without a significant difference (P = 0.113).
Conclusions
Our randomised clinical trial suggested that intravesical therapy with MMC and Ara‐C is useful and safe for patients with intermediate‐risk NMIBC. Increase in urinary pH with Ara‐C is speculated as a mechanism for increased anti‐cancer effects.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/bju.15571</identifier><identifier>PMID: 34383381</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Administration, Intravesical ; Antibiotics, Antineoplastic - therapeutic use ; Bladder cancer ; BladderCancer ; blcsm ; Cancer ; Clinical trials ; Cytarabine ; Cytarabine - therapeutic use ; Cytosine ; cytosine arabinoside ; Female ; Humans ; intravesical therapy ; Invasiveness ; Male ; Mitomycin - therapeutic use ; Mitomycin C ; Multivariate analysis ; non‐muscle‐invasive bladder cancer ; Original ; Patients ; pH effects ; randomised trial ; Toxicity ; Urinary Bladder Neoplasms - surgery ; urinary pH ; uroonc</subject><ispartof>BJU international, 2022-04, Vol.129 (4), p.534-541</ispartof><rights>2021 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International</rights><rights>2021 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.</rights><rights>2021. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3581-c8e6f85ec0b8a903acc3a988343dcc168fcd25f1c3a19625166237fb5bea4e8d3</citedby><cites>FETCH-LOGICAL-c3581-c8e6f85ec0b8a903acc3a988343dcc168fcd25f1c3a19625166237fb5bea4e8d3</cites><orcidid>0000-0001-6272-6657</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbju.15571$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbju.15571$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34383381$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Miyata, Yasuyoshi</creatorcontrib><creatorcontrib>Tsurusaki, Toshifumi</creatorcontrib><creatorcontrib>Hayashida, Yasushi</creatorcontrib><creatorcontrib>Imasato, Yushi</creatorcontrib><creatorcontrib>Takehara, Kosuke</creatorcontrib><creatorcontrib>Aoki, Daiyu</creatorcontrib><creatorcontrib>Nishikido, Masaharu</creatorcontrib><creatorcontrib>Watanabe, Junichi</creatorcontrib><creatorcontrib>Mitsunari, Kensuke</creatorcontrib><creatorcontrib>Matsuo, Tomohiro</creatorcontrib><creatorcontrib>Ohba, Kojiro</creatorcontrib><creatorcontrib>Taniguchi, Keisuke</creatorcontrib><creatorcontrib>Sakai, Hideki</creatorcontrib><creatorcontrib>Nagasaki University Urological Oncology Research Group</creatorcontrib><creatorcontrib>the Nagasaki University Urological Oncology Research Group</creatorcontrib><title>Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>Objectives
To compare the urinary pH, recurrence‐free survival (RFS), and safety of adjuvant intravesical therapy in patients with non‐muscle‐invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara‐C) therapy.
Patients and Methods
A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara‐C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.
Results
A total of 81 and 87 patients were randomised into the MMC and MMC + Ara‐C groups, respectively. Overall, the RFS in the MMC + Ara‐C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate‐risk NMIBC, but not in those with high‐risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara‐C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara‐C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18–0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara‐C groups, respectively, without a significant difference (P = 0.113).
Conclusions
Our randomised clinical trial suggested that intravesical therapy with MMC and Ara‐C is useful and safe for patients with intermediate‐risk NMIBC. Increase in urinary pH with Ara‐C is speculated as a mechanism for increased anti‐cancer effects.</description><subject>Administration, Intravesical</subject><subject>Antibiotics, Antineoplastic - therapeutic use</subject><subject>Bladder cancer</subject><subject>BladderCancer</subject><subject>blcsm</subject><subject>Cancer</subject><subject>Clinical trials</subject><subject>Cytarabine</subject><subject>Cytarabine - therapeutic use</subject><subject>Cytosine</subject><subject>cytosine arabinoside</subject><subject>Female</subject><subject>Humans</subject><subject>intravesical therapy</subject><subject>Invasiveness</subject><subject>Male</subject><subject>Mitomycin - therapeutic use</subject><subject>Mitomycin C</subject><subject>Multivariate analysis</subject><subject>non‐muscle‐invasive bladder cancer</subject><subject>Original</subject><subject>Patients</subject><subject>pH effects</subject><subject>randomised trial</subject><subject>Toxicity</subject><subject>Urinary Bladder Neoplasms - surgery</subject><subject>urinary pH</subject><subject>uroonc</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kU1rFTEUhoNYbK0u_AMScNMit00mH824EPRiP6TFjQV3IZOc0VwySZvMXLm7brvzN_aXmPa2RQUDIS8nD2_OyYvQK0r2aF373WLao0Ic0Cdoi3LJZ5ySb08fNGnlJnpeyoKQWpDiGdpknCnGFN1C1ydxzGYJxVsT8ODHNKysj3iOd87O5rvYRIeruLm6flu3XY2p-AjYZNP5WLUD3KeMY4o3V7-GqdgAVfi4NMUvAXfBOAcZWxMt5HfY4Fwd0-ALOGyDj3fPjtmb8AJt9CYUeHl_bqPzw09f58ez0y9HJ_MPpzPLhKIzq0D2SoAlnTItYcZaZlql6kjOWipVb10jelqrtJWNoFI27KDvRAeGg3JsG71f-15M3QDOwu0HBH2R_WDySifj9d830f_Q39NSt01LuBDVYOfeIKfLCcqo6zgWQjAR0lR0IyRRjDRSVfTNP-giTTnW8XQjOW-4YJJWandN2ZxKydA_NkOJvg1Y14D1XcCVff1n94_kQ6IV2F8DP32A1f-d9MfP52vL3_s0tYI</recordid><startdate>202204</startdate><enddate>202204</enddate><creator>Miyata, Yasuyoshi</creator><creator>Tsurusaki, Toshifumi</creator><creator>Hayashida, Yasushi</creator><creator>Imasato, Yushi</creator><creator>Takehara, Kosuke</creator><creator>Aoki, Daiyu</creator><creator>Nishikido, Masaharu</creator><creator>Watanabe, Junichi</creator><creator>Mitsunari, Kensuke</creator><creator>Matsuo, Tomohiro</creator><creator>Ohba, Kojiro</creator><creator>Taniguchi, Keisuke</creator><creator>Sakai, Hideki</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</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>7QP</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6272-6657</orcidid></search><sort><creationdate>202204</creationdate><title>Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial</title><author>Miyata, Yasuyoshi ; Tsurusaki, Toshifumi ; Hayashida, Yasushi ; Imasato, Yushi ; Takehara, Kosuke ; Aoki, Daiyu ; Nishikido, Masaharu ; Watanabe, Junichi ; Mitsunari, Kensuke ; Matsuo, Tomohiro ; Ohba, Kojiro ; Taniguchi, Keisuke ; Sakai, Hideki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3581-c8e6f85ec0b8a903acc3a988343dcc168fcd25f1c3a19625166237fb5bea4e8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Administration, Intravesical</topic><topic>Antibiotics, Antineoplastic - therapeutic use</topic><topic>Bladder cancer</topic><topic>BladderCancer</topic><topic>blcsm</topic><topic>Cancer</topic><topic>Clinical trials</topic><topic>Cytarabine</topic><topic>Cytarabine - therapeutic use</topic><topic>Cytosine</topic><topic>cytosine arabinoside</topic><topic>Female</topic><topic>Humans</topic><topic>intravesical therapy</topic><topic>Invasiveness</topic><topic>Male</topic><topic>Mitomycin - therapeutic use</topic><topic>Mitomycin C</topic><topic>Multivariate analysis</topic><topic>non‐muscle‐invasive bladder cancer</topic><topic>Original</topic><topic>Patients</topic><topic>pH effects</topic><topic>randomised trial</topic><topic>Toxicity</topic><topic>Urinary Bladder Neoplasms - surgery</topic><topic>urinary pH</topic><topic>uroonc</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Miyata, Yasuyoshi</creatorcontrib><creatorcontrib>Tsurusaki, Toshifumi</creatorcontrib><creatorcontrib>Hayashida, Yasushi</creatorcontrib><creatorcontrib>Imasato, Yushi</creatorcontrib><creatorcontrib>Takehara, Kosuke</creatorcontrib><creatorcontrib>Aoki, Daiyu</creatorcontrib><creatorcontrib>Nishikido, Masaharu</creatorcontrib><creatorcontrib>Watanabe, Junichi</creatorcontrib><creatorcontrib>Mitsunari, Kensuke</creatorcontrib><creatorcontrib>Matsuo, Tomohiro</creatorcontrib><creatorcontrib>Ohba, Kojiro</creatorcontrib><creatorcontrib>Taniguchi, Keisuke</creatorcontrib><creatorcontrib>Sakai, Hideki</creatorcontrib><creatorcontrib>Nagasaki University Urological Oncology Research Group</creatorcontrib><creatorcontrib>the Nagasaki University Urological Oncology Research Group</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Miyata, Yasuyoshi</au><au>Tsurusaki, Toshifumi</au><au>Hayashida, Yasushi</au><au>Imasato, Yushi</au><au>Takehara, Kosuke</au><au>Aoki, Daiyu</au><au>Nishikido, Masaharu</au><au>Watanabe, Junichi</au><au>Mitsunari, Kensuke</au><au>Matsuo, Tomohiro</au><au>Ohba, Kojiro</au><au>Taniguchi, Keisuke</au><au>Sakai, Hideki</au><aucorp>Nagasaki University Urological Oncology Research Group</aucorp><aucorp>the Nagasaki University Urological Oncology Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2022-04</date><risdate>2022</risdate><volume>129</volume><issue>4</issue><spage>534</spage><epage>541</epage><pages>534-541</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>Objectives
To compare the urinary pH, recurrence‐free survival (RFS), and safety of adjuvant intravesical therapy in patients with non‐muscle‐invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara‐C) therapy.
Patients and Methods
A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara‐C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.
Results
A total of 81 and 87 patients were randomised into the MMC and MMC + Ara‐C groups, respectively. Overall, the RFS in the MMC + Ara‐C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate‐risk NMIBC, but not in those with high‐risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara‐C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara‐C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18–0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara‐C groups, respectively, without a significant difference (P = 0.113).
Conclusions
Our randomised clinical trial suggested that intravesical therapy with MMC and Ara‐C is useful and safe for patients with intermediate‐risk NMIBC. Increase in urinary pH with Ara‐C is speculated as a mechanism for increased anti‐cancer effects.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34383381</pmid><doi>10.1111/bju.15571</doi><tpages>541</tpages><orcidid>https://orcid.org/0000-0001-6272-6657</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | BJU international, 2022-04, Vol.129 (4), p.534-541 |
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| subjects | Administration, Intravesical Antibiotics, Antineoplastic - therapeutic use Bladder cancer BladderCancer blcsm Cancer Clinical trials Cytarabine Cytarabine - therapeutic use Cytosine cytosine arabinoside Female Humans intravesical therapy Invasiveness Male Mitomycin - therapeutic use Mitomycin C Multivariate analysis non‐muscle‐invasive bladder cancer Original Patients pH effects randomised trial Toxicity Urinary Bladder Neoplasms - surgery urinary pH uroonc |
| title | Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non‐muscle‐invasive bladder cancer: a randomised clinical trial |
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