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Perspectives and Experience in Treating Bladder Cancer & Expectations for Phase III trial

Perspectives and Experience in Treating Bladder Cancer & Expectations for Phase III trial. Harry W. Herr, M.D. Department of Urology Memorial Sloan-Kettering Cancer Center. Transurethral Resection of Bladder Tumors. Bladder Lumen. Tumor B. Tumor A. 3 cm. 3 cm. 2 cm. Mucosa. Mucosa.

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Perspectives and Experience in Treating Bladder Cancer & Expectations for Phase III trial

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  1. Perspectives and Experience in Treating Bladder Cancer & Expectations for Phase III trial Harry W. Herr, M.D. Department of Urology Memorial Sloan-Kettering Cancer Center

  2. Transurethral Resection of Bladder Tumors Bladder Lumen Tumor B Tumor A 3 cm 3 cm 2 cm Mucosa Mucosa Lamina Propria Broad-front Invasion Tentacular Invasion B A A B C B A A B C Muscle

  3. High-Risk Superficial Bladder Cancer

  4. Local Invasion of Carcinoma in situ of the Bladder

  5. History of BCG Pasteur Institute, 1908 Lille, France Albert Calmette French bacteriologist Camille Guerin veterinarian M. bovis

  6. BCG and Bladder CancerHistory • 1929 Pearl, Baltimore, TBC < cancer • 1959 Old LJ (MSK), antitumor effect of BCG • 1970 Zbar (NCI), BCG in guinea pig and man • 1970 Morton, intralesional BCG in melanoma • 1974 deKernion (NCI), BCG bladder melanoma • 1976 Morales (NCI), intravesical BCG • 1979-84, MSKCC and SWOG randomized trials • 1990, FDA approved use of BCG against CIS

  7. Tumor progression P=.006 BCG TUR Survival P=.03 BCG TUR Herr H, et al: Randomized trial of BCG therapy with 10-year follow-up JCO 13: 1404, 1995

  8. 33% 40% 52%

  9. 10-15% 25% 34% N=307; 15-20 year follow-up

  10. Maintenance BCG immunotherapy for Ta, T1 and Tis; A SWOG randomized studyTumor after induction BCG excluded, N=384 recur Recurrence Progression Survival Lamm et al J Urol 2002:163:1124

  11. TaG3, T1, CIS (n=588 pts) RANDOMIZE RANDOMIZE BCG MCC BCG MCC 6 weeks Maintenance 3,6,9,12,18,21,24,30,36 mos Maintenance 3, 6, 12, 18, 24, 30, 36 mos Cystoscopy and TUR every 3 to 6 mos Cystoscopy and TUR every 3 to 6 mos Response (CR) and tolerability Response (CR) and tolerance USA, Canada, France

  12. Expectations for Phase III trial • Fewer tumor recurrences • Fewer invasive procedures (TURs) • Less tumor progression (life-threatening) • Improved survival • Better tolerability (repeated doses necessary)

  13. Treatment of BCG-Failures

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