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Intravesical Thiotepa versus Mitomycin C in Patients with TA, T1 and TIS Transitional Cell Carcinoma of the Bladder: A Phase III Prospective Randomized Study

1988; Lippincott Williams & Wilkins; Volume: 140; Issue: 6 Linguagem: Inglês

10.1016/s0022-5347(17)42052-0

1527-3792

Niall M. Heney, Warren W. Koontz, Bruce Barton, Mark S. Soloway, Donald L. Trump, Tapan A. Hazra, Ronald S. Weinstein,

Renal cell carcinoma treatment

No AccessJournal of Urology1 Dec 1988Intravesical Thiotepa versus Mitomycin C in Patients with TA, T1 and TIS Transitional Cell Carcinoma of the Bladder: A Phase III Prospective Randomized Study Niall M. Heney, Warren W. Koontz, Bruce Barton, Mark Soloway, Donald L. Trump, Tapan Hazra, Ronald S. Weinstein, and The National Bladder Cancer Group‡ Niall M. HeneyNiall M. Heney More articles by this author , Warren W. KoontzWarren W. Koontz More articles by this author , Bruce BartonBruce Barton More articles by this author , Mark SolowayMark Soloway More articles by this author , Donald L. TrumpDonald L. Trump More articles by this author , Tapan HazraTapan Hazra Deceased. More articles by this author , Ronald S. WeinsteinRonald S. Weinstein More articles by this author , and The National Bladder Cancer Group‡ G. R. Prout, Jr., Massachusetts General Hospital, Boston, Massachusetts (CA23082 and CA15944); M. Soloway, University of Tennessee, Memphis, Tennessee (CA15934); G. Brannen, Virginia Mason Research Center, Seattle, Washington (CA17466); S. Cutler, Georgetown University, Washington, D. C. and G. Knatternd, Maryland Medical Research Institute, Baltimore, Maryland (CA23078); S. Loening, University of Iowa, Iowa City, Iowa (CA15933); M. J. Flanagan, Rush Presbyterian-St. Luke’s, Chicago, Illinois (CÁ16866); H. Pearse, University of Oregon, Portland, Oregon (CA25918); J. E. Pontes and R. Huben, Roswell Park Memorial Institute, Buffalo, New York (CA15937); W. W. Koontz, Jr., Medical College of Virginia, Richmond, Virginia (CA15492); Gilbert Friedell, St. Vincent’s Hospital, Worcester, Massachusetts and R. Weinstein, Rush Presbyterian-St. Luke’s Hospital, Chicago, Illinois (CA36641); K. Cummings, University of Wisconsin, Madison, Wisconsin (CA31793); Z. Wajsman, University of Florida, Gainesville, Florida; M. Droller, Mt. Sinai Hospital, New York, New York, and Joseph Schmidt, University of California, San Diego, California. More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(17)42052-0AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail A prospective randomized clinical trial was conducted by the National Bladder Cancer Group to compare thiotepa and mitomycin C in ablating residual Ta, T1 and TIS transitional cell carcinoma of the bladder. Eight weekly instillations were given followed by cystoscopy 4 weeks after the treatment was stopped. The over-all complete response rate based on cystoscopy and either biopsy or cytology was 26 per cent for thiotepa versus 39 per cent for mitomycin C (p equals 0.08). The greatest efficacy was seen in the Ta group with mitomycin C demonstrating superiority over thiotepa. Patients with negative cystoscopy and biopsy but who had positive cytology were considered to be partial responders. When partial and complete responders were combined the over-all response rate was 53 per cent for thiotepa and 63 per cent for mitomycin C (p equals 0.23). Patients with TIS appeared to respond equally to thiotepa and mitomycin C. Toxicity included urinary frequency in 22 of the 73 patients in the thiotepa arm and 31 of the 76 patients receiving mitomycin C. A rash was observed in 2 of the thiotepa group versus 14 of the mitomycin C group. Bone marrow depression occurred in 15 patients receiving thiotepa and in 12 receiving mitomycin C. © 1988 by The American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byRose A, El-Leithy T, Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S and Rübben H (2015) Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation StudyJournal of Urology, VOL. 194, NO. 4, (939-943), Online publication date: 1-Oct-2015.Gofrit O, Zorn K, Shikanov S and Steinberg G (2010) Marker Lesion Experiments in Bladder Cancer—What Have We Learned?Journal of Urology, VOL. 183, NO. 5, (1678-1685), Online publication date: 1-May-2010.van der Heijden A, Moonen P, Cornel E, Vergunst H, de Reijke T, van Boven E, Barten E, Puri R, van Kalken C and Witjes J (2018) Phase II Marker Lesion Study With Intravesical Instillation of Apaziquone for Superficial Bladder Cancer: Toxicity and Marker ResponseJournal of Urology, VOL. 176, NO. 4, (1349-1353), Online publication date: 1-Oct-2006.Krege S, Giani G, Meyer R, Otto T and Rubben H (2018) A Randomized Multicenter Trial of Adjuvant Therapy in Superficial Bladder Cancer: Transurethral Resection Only Versus Transurethral Resection Plus Mitomycin C Versus Transurethral Resection Plus Bacillus Calmette-GuerinJournal of Urology, VOL. 156, NO. 3, (962-966), Online publication date: 1-Sep-1996.Bouffioux C, Denis L, Oosterlinck W, Viggiano G, Vergison B, Keuppens F, De Pauw M, Sylvester R and Cheuvart B (2018) Adjuvant Chemotherapy of Recurrent Superficial Transitional Cell Carcinoma: Results of a European Organization for Research on Treatment of Cancer Randomized Trial Comparing Intravesical Instillation of Thiotepa, Doxorubicin and CisplatinJournal of Urology, VOL. 148, NO. 2 Part 1, (297-301), Online publication date: 1-Aug-1992.Steinberg G, Brendler C, Squire R and Isaacs J (2018) Experimental Intravesical Therapy for Superficial Transitional Cell Carcinoma in a Rat Bladder Tumor ModelJournal of Urology, VOL. 145, NO. 3, (647-653), Online publication date: 1-Mar-1991. (2018) Reply by AuthorsJournal of Urology, VOL. 142, NO. 4, (1072-1072), Online publication date: 1-Oct-1989.Soloway M (2018) Editorial CommentJournal of Urology, VOL. 142, NO. 4, (1072-1072), Online publication date: 1-Oct-1989.Drago P, Badalament R, Lucas J and Drago J (2018) Bladder Wall Calcification after Intravesical Mitomycin C Treatment of Superficial Bladder CancerJournal of Urology, VOL. 142, NO. 4, (1071-1072), Online publication date: 1-Oct-1989. Volume 140Issue 6December 1988Page: 1390-1393 Advertisement Copyright & Permissions© 1988 by The American Urological Association Education and Research, Inc.MetricsAuthor Information Niall M. Heney More articles by this author Warren W. Koontz More articles by this author Bruce Barton More articles by this author Mark Soloway More articles by this author Donald L. Trump More articles by this author Tapan Hazra Deceased. More articles by this author Ronald S. Weinstein More articles by this author The National Bladder Cancer Group‡ G. R. Prout, Jr., Massachusetts General Hospital, Boston, Massachusetts (CA23082 and CA15944); M. Soloway, University of Tennessee, Memphis, Tennessee (CA15934); G. Brannen, Virginia Mason Research Center, Seattle, Washington (CA17466); S. Cutler, Georgetown University, Washington, D. C. and G. Knatternd, Maryland Medical Research Institute, Baltimore, Maryland (CA23078); S. Loening, University of Iowa, Iowa City, Iowa (CA15933); M. J. Flanagan, Rush Presbyterian-St. Luke’s, Chicago, Illinois (CÁ16866); H. Pearse, University of Oregon, Portland, Oregon (CA25918); J. E. Pontes and R. Huben, Roswell Park Memorial Institute, Buffalo, New York (CA15937); W. W. Koontz, Jr., Medical College of Virginia, Richmond, Virginia (CA15492); Gilbert Friedell, St. Vincent’s Hospital, Worcester, Massachusetts and R. Weinstein, Rush Presbyterian-St. Luke’s Hospital, Chicago, Illinois (CA36641); K. Cummings, University of Wisconsin, Madison, Wisconsin (CA31793); Z. Wajsman, University of Florida, Gainesville, Florida; M. Droller, Mt. Sinai Hospital, New York, New York, and Joseph Schmidt, University of California, San Diego, California. More articles by this author Expand All Advertisement PDF downloadLoading ...