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

Journal of Urology

Volumn 195, Issue 1, 2016, Pages 41-46

  Yokomizo, Akira ^a   Kanimoto, Yusuke ^c   Okamura, Takehiko ^d   Ozono, Seiichiro ^e   Koga, Hirofumi ^b   Iwamura, Masatsugu ^g   Tanaka, Hiroshi ^h   Takahashi, Satoru ^j   Tsushima, Tomoyasu ^m   Kanayama, Hiro Omi ⁿ   Akaza, Hideyuki ^k   Shinohara, Nobuo ⁱ   Mugiya, Soichi ^f   Nomata, Koichiro ^o   Nakamura, Tsuyoshi ^l   Naito, Seiji ^a  

^a KYUSHU UNIVERSITY   (Japan)

^b HARASANSHIN HOSPITAL   (Japan)

^c Chutoen General Medical Center   (Japan)

^d ANJO KOSEI HOSPITAL   (Japan)

^e HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f Suzukake Central Hospital   (Japan)

^g KITASATO UNIVERSITY   (Japan)

^h SAPPORO CITY GENERAL HOSPITAL   (Japan)

ⁱ HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^j NIHON UNIVERSITY   (Japan)

^k UNIVERSITY OF TOKYO   (Japan)

^l CHUO UNIVERSITY   (Japan)

^m Okayama Medical Association   (Japan)

ⁿ UNIVERSITY OF TOKUSHIMA   (Japan)

^o Nagasaki Harbor Medical Center City Hospital   (Japan)

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Author keywords

administration and dosage; mycobacterium bovis; quality of life; urinary bladder neoplasms

Indexed keywords

BCG VACCINE; IMMUNOLOGICAL ADJUVANT;

AGED; ARTICLE; CANCER IMMUNOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARCINOMA IN SITU; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DYSURIA; FEMALE; FEVER; HUMAN; HUMAN TISSUE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MYCOBACTERIUM BOVIS BCG; NON MUSCLE INVASIVE BLADDER CANCER; NULL HYPOTHESIS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENCE FREE SURVIVAL; TRANSURETHRAL RESECTION; TREATMENT RESPONSE; TUMOR BIOPSY; INTRAVESICAL DRUG ADMINISTRATION; PATHOLOGY; TREATMENT OUTCOME; TUMOR INVASION; URINARY BLADDER NEOPLASMS;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, INTRAVESICAL; AGED; BCG VACCINE; FEMALE; HUMANS; MALE; NEOPLASM INVASIVENESS; QUALITY OF LIFE; TREATMENT OUTCOME; URINARY BLADDER NEOPLASMS;

EID: 84951069679     PISSN: 00225347     EISSN: 15273792     Source Type: Journal    
DOI: 10.1016/j.juro.2015.08.075     Document Type: Article

References (15)

1. A. Morales, D. Eidinger, and A.W. Bruce Intracavitary bacillus Calmette-Guerin in the treatment of superficial bladder tumors J Urol 116 1976 180
2. T. Takeda, E. Kikuchi, K. Yuge, and et al. Discontinuance of bacille Calmette-Guerin instillation therapy for nonmuscle-invasive bladder cancer has negative effect on tumor recurrence Urology 73 2009 1318
3. J.A. Martínez-Piñeiro, N. Flores, S. Isorna, and et al. Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guérin with a reduced dose of 27 mg in superficial bladder cancer BJU Int 89 2002 671
4. J.A. Martínez-Piñeiro, L. Martínez-Piñeiro, E. Solsona, and et al. Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial J Urol 174 2005 1242
5. A. Ojea, J.L. Nogueira, E. Solsona, and et al. A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C Eur Urol 52 2007 1398
6. S.J. Pocock, and R. Simon Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial Biometrics 31 1975 103
7. A. Trotti, A.D. Colevas, A. Setser, and et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment Semin Radiat Oncol 13 2003 176
8. S. Mugiya, S. Ozono, M. Nagata, and et al. Long-term outcome of a low-dose intravesical bacillus Calmette-Guerin therapy for carcinoma in situ of the bladder: results after six successive instillations of 40 mg BCG Jpn J Clin Oncol 35 2005 395
9. J. Oddens, M. Brausi, R. Sylvester, and et al. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance Eur Urol 63 2013 462
10. M. Babjuk, M. Burger, R. Zigeuner, and et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013 Eur Urol 64 2013 639
11. R.A. Badalament, H.W. Herr, G.Y. Wong, and et al. A prospective randomized trial of maintenance versus nonmaintenance intravesical bacillus Calmette-Guerin therapy of superficial bladder cancer J Clin Oncol 5 1987 441
12. M.A. Hudson, T.L. Ratliff, D.P. Gillen, and et al. Single course versus maintenance bacillus Calmette-Guerin therapy for superficial bladder tumors: a prospective, randomized trial J Urol 138 1987 295
13. D.L. Lamm, B.A. Blumenstein, J.D. Crissman, and et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study J Urol 163 2000 1124
14. S. Hinotsu, H. Akaza, S. Naito, and et al. Maintenance therapy with bacillus Calmette-Guerin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscle-invasive bladder cancer BJU Int 108 2011 187
15. B. Ehdaie, R. Sylvester, and H.W. Herr Maintenance bacillus Calmette-Guerin treatment of non-muscle-invasive bladder cancer: a critical evaluation of the evidence Eur Urol 64 2013 579