Neoadjuvant Gemcitabine-Cisplatin Plus Radical Cystectomy-Pelvic Lymph Node Dissection for Muscle-invasive Bladder Cancer: A 12-year Experience |
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| Affiliation: | 1. Department of Medicine, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY;2. Department of Medicine, Weill Cornell Medical College, New York, NY;3. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY;4. Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Center, New York, NY;5. Division of Hematology/Oncology, Department of Medicine, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC;1. Department of Urology, Medical University of Vienna, Vienna, Austria;2. Department of Urology, Jikei University School of Medicine, Tokyo, Japan;3. Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan;4. Department of Special Surgery, Jordan University Hospital, The University of Jordan, Amman, Jordan;5. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;6. Klinik für Urologie, Luzerner Kantonsspital, Lucerne, Switzerland;7. Urological Research Institute, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy;8. Department for Gynaecology and Gynaecologic Oncology, Medical University of Vienna, Vienna, Austria;9. Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia;10. Department of Urology, Weill Cornell Medical College, New York, NY;11. Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX;12. Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria;1. Department of Urology, University Hospital Frankfurt, Frankfurt am Main, Germany;2. Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, Québec, Canada;3. Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany;4. Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy;5. Department of Urology, University of Naples Federico II, Naples, Italy;6. Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria;7. Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University, Moscow, Russia;8. Department of Urology, University of Jordan, Amman, Jordan;9. Department of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, British Colombia, Canada;10. Department of Urology, McGill University Health Centre, Montréal, Québec, Canada;1. Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women‘s Hospital, Harvard Medical School, Boston, MA;2. Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany;3. Department of Urology, Pitié Salpétrière Hospital, Assistance Publique des Hôpitaux de Paris, Pierre and Marie Curie University, Paris, France;4. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;5. Vattikuti Urology Institute, Vattikuti Urology Institute (VUI) Center for Outcomes Research Analytics and Evaluation, Henry Ford Hospital, Detroit, MI;6. Division of Urological Surgery, Brigham and Women''s Hospital, Harvard Medical School, Boston, MA;1. Department of Urology, Mayo Clinic, Rochester, MN, USA;2. Department of Urology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;3. Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA;4. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA;1. Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA;2. Weill Cornell Medical College, New York, NY, USA;3. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA;4. Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA;5. Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA;6. Division of Hematology/Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;7. Department of Medical Oncology, NYU Langone Health, New York, NY, USA;8. Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA |
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| Abstract: | IntroductionThe aim of this study was to determine drug delivery/toxicity, and pathologic/surgical outcomes of patients with muscle-invasive bladder cancer (MIBC) receiving neoadjuvant gemcitabine-cisplatin (GC) plus radical cystectomy-pelvic lymph node dissection (RC-PLND).Patients and MethodsChemotherapy and surgical/pathologic outcomes were retrospectively analyzed with 5-year survival follow-up at a referral center. Post-neoadjuvant chemotherapy (NAC) pathologic endpoints included complete response (pT0N0), residual non-MIBC (pTa/Tis/T1N0), and ≥ MIBC (≥ pT2 and/or N+). Associations of pathologic/surgical findings with overall survival (OS), disease-free survival (DFS), and surgical management with RC-PLND were analyzed (Cox regression).ResultsClinical T2a-T4aN0M0 MIBC patients (n = 154) from January 2000-October 2012 received GC plus RC-PLND. Patients (n = 117; 76%) received GC × 4 and 136 (88%) GC × 3. Five-year OS was 61% (95% confidence interval [CI], 53-71). Median number of resected lymph nodes (LNs) was 19. Down-staging was observed as follows: pT0N0: 21%; pTa/Tis/T1N0: 25%, with similar 5-year OS (85% and 89%, respectively). Five-year OS for < pT2 versus ≥ pT2 residual disease was 87% (95% CI, 78%-98%) versus 38% (95% CI, 27%-53%); P < .001. Post-NAC stage ≥ pT2 (HR, 6.79; 95% CI, 2.63-17.53; P < .001), positive LN (HR, 3.64; 95% CI, 1.84-7.19; P < .001), and positive margins (HR, 4.15; 95% CI, 1.68-10.25; P = .002) were associated with increased risk of all-cause death (multivariable analysis). An HR of 0.97 (95% CI, 0.94-1.00) was observed for each additional node removed, but this effect was not statistically significant (P = .056).ConclusionsNeoadjuvant GC achieves meaningful pathologic responses. Patients with ≥ pT2 residual disease, positive margins, or positive LN post-chemotherapy have inferior survival. |
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| Keywords: | Bladder cancer Complete pathologic response Neoadjuvant chemotherapy Pathologic downstaging Urothelial carcinoma |
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