Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Guérin Instillation Therapy for Nonmuscle Invasive Bladder Cancer

No AccessJournal of UrologyAdult Urology1 Jan 2016Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Guérin Instillation Therapy for Nonmuscle Invasive Bladder Cancer Akira Yokomizo, Yusuke Kanimoto, Takehiko Okamura, Seiichiro Ozono, Hirofumi Koga, Masatsugu Iwamura, Hiroshi Tanaka, Satoru Takahashi, Tomoyasu Tsushima, Hiro-omi Kanayama, Hideyuki Akaza, Nobuo Shinohara, Soichi Mugiya, Koichiro Nomata, Tsuyoshi Nakamura, and Seiji Naito Akira YokomizoAkira Yokomizo Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Recipient of honoraria from Japan BCG Laboratory Co., Ltd., More articles by this author , Yusuke KanimotoYusuke Kanimoto Department of Urology, Chutoen General Medical Center, Kakegawa, Japan More articles by this author , Takehiko OkamuraTakehiko Okamura Department of Urology, Anjo Kosei Hospital, Anjo, Japan More articles by this author , Seiichiro OzonoSeiichiro Ozono Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan Recipient of honoraria from Nipponkayaku Co. Ltd. and Sanofi Aventis. More articles by this author , Hirofumi KogaHirofumi Koga Department of Urology, Harasanshin Hospital, Fukuoka, Japan More articles by this author , Masatsugu IwamuraMasatsugu Iwamura Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan More articles by this author , Hiroshi TanakaHiroshi Tanaka Department of Urology, Sapporo City General Hospital, Sapporo, Japan More articles by this author , Satoru TakahashiSatoru Takahashi Department of Urology, Nihon University College of Medicine, Tokyo, Japan More articles by this author , Tomoyasu TsushimaTomoyasu Tsushima Department of Urology, Okayama Medical Center, Okayama, Japan More articles by this author , Hiro-omi KanayamaHiro-omi Kanayama Department of Urology, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan More articles by this author , Hideyuki AkazaHideyuki Akaza Department of Strategic Investigation on Comprehensive Cancer Network, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan More articles by this author , Nobuo ShinoharaNobuo Shinohara Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan More articles by this author , Soichi MugiyaSoichi Mugiya Department of Urology, Suzukake Central Hospital, Hamamatsu, Japan More articles by this author , Koichiro NomataKoichiro Nomata Department of Urology, Nagasaki Harbor Medical Center City Hospital, Nagasaki, Japan More articles by this author , Tsuyoshi NakamuraTsuyoshi Nakamura Graduate School of Science and Engineering, Chuo University, Tokyo, Japan More articles by this author , and Seiji NaitoSeiji Naito Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Recipient of honoraria from Japan BCG Laboratory Co., Ltd., More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.08.075AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The optimal dose of intravesical bacillus Calmette-Guérin for the treatment of nonmuscle invasive bladder cancer is controversial. We investigated if induction therapy with low dose bacillus Calmette-Guérin could achieve a complete response rate similar to that of standard dose bacillus Calmette-Guérin, with less toxicity and higher quality of life. Materials and Methods: After transurethral resection, patients with unresectable multiple nonmuscle invasive bladder cancer and/or carcinoma in situ were randomized to receive standard (80 mg) or low dose (40 mg) bacillus Calmette-Guérin instillation induction therapy (weekly, 8 times). The primary end point was noninferiority of low dose bacillus Calmette-Guérin with a null hypothesis of a 15% decrease in complete response rate. Secondary end points were recurrence-free survival, progression-free survival, overall survival, patient compliance, adverse events and quality of life using the EORTC QLQ-C30. Results: In an intent to treat analysis of 166 patients the complete response rates for low dose and standard dose bacillus Calmette-Guérin were 79% (95% CI 0.70–0.88) and 85% (95% CI 0.77–0.92), respectively. Dunnett-Gent analysis revealed that the null hypothesis of inferiority of low dose bacillus Calmette-Guérin in terms of complete response could not be rejected (p = 0.119). However, there were no significant differences between the groups in terms of recurrence, progression and overall survival. Low dose bacillus Calmette-Guérin was associated with significantly less fever (p = 0.001) and micturition pain (p = 0.047), and significantly higher quality of life scores for global quality of life, role functioning and functional impairment. Conclusions: The noninferiority of low dose bacillus Calmette-Guérin was not proven. 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Google Scholar © 2016 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byChang S (2018) Re: Intravesical rAd-IFNα/Syn3 for Patients with High-Grade, bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized StudyJournal of Urology, VOL. 200, NO. 6, (1164-1164), Online publication date: 1-Dec-2018.Leitner C, Ederer I, de Martino M, Hofbauer S, Lucca I, Mbeutcha A, Mathieu R, Haitel A, Susani M, Shariat S and Klatte T (2016) Dynamic Prognostication Using Conditional Recurrence and Progression Estimates for Patients with Nonmuscle Invasive Bladder CancerJournal of Urology, VOL. 196, NO. 1, (46-51), Online publication date: 1-Jul-2016. Volume 195Issue 1January 2016Page: 41-46Supplementary Materials Advertisement Copyright & Permissions© 2016 by American Urological Association Education and Research, Inc.Keywordsadministration and dosageurinary bladder neoplasmsmycobacterium bovisquality of lifeMetricsAuthor Information Akira Yokomizo Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Recipient of honoraria from Japan BCG Laboratory Co., Ltd., More articles by this author Yusuke Kanimoto Department of Urology, Chutoen General Medical Center, Kakegawa, Japan More articles by this author Takehiko Okamura Department of Urology, Anjo Kosei Hospital, Anjo, Japan More articles by this author Seiichiro Ozono Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan Recipient of honoraria from Nipponkayaku Co. Ltd. and Sanofi Aventis. More articles by this author Hirofumi Koga Department of Urology, Harasanshin Hospital, Fukuoka, Japan More articles by this author Masatsugu Iwamura Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan More articles by this author Hiroshi Tanaka Department of Urology, Sapporo City General Hospital, Sapporo, Japan More articles by this author Satoru Takahashi Department of Urology, Nihon University College of Medicine, Tokyo, Japan More articles by this author Tomoyasu Tsushima Department of Urology, Okayama Medical Center, Okayama, Japan More articles by this author Hiro-omi Kanayama Department of Urology, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan More articles by this author Hideyuki Akaza Department of Strategic Investigation on Comprehensive Cancer Network, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan More articles by this author Nobuo Shinohara Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan More articles by this author Soichi Mugiya Department of Urology, Suzukake Central Hospital, Hamamatsu, Japan More articles by this author Koichiro Nomata Department of Urology, Nagasaki Harbor Medical Center City Hospital, Nagasaki, Japan More articles by this author Tsuyoshi Nakamura Graduate School of Science and Engineering, Chuo University, Tokyo, Japan More articles by this author Seiji Naito Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan Recipient of honoraria from Japan BCG Laboratory Co., Ltd., More articles by this author Expand All Advertisement PDF downloadLoading ...