Matthew D Galsky1, Sumanta K Pal2, Simon Chowdhury3, Lauren C Harshman4, Simon J Crabb5, Yu-Ning Wong6, Evan Y Yu7, Thomas Powles8, Erin L Moshier9, Sylvain Ladoire10, Syed A Hussain11, Neeraj Agarwal12, Ulka N Vaishampayan13, Federica Recine14, Dominik Berthold15, Andrea Necchi16, Christine Theodore17, Matthew I Milowsky18, Joaquim Bellmunt4, Jonathan E Rosenberg19. 1. Department of Hematology and Medical Oncology, Mount Sinai Medical Center, New York, New York. 2. Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, California. 3. Department of Urology, Guy's and St. Thomas' Hospital, London, United Kingdom. 4. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. 5. Department of Medical Oncology, Southampton General Hospital, Southampton, United Kingdom. 6. Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. 7. Division of Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle, Washington. 8. Department of Medical Oncology, Barts Cancer Institute, London, United Kingdom. 9. Division of Biostatistics, Department of Preventative Medicine, Mount Sinai Medical Center, New York, New York. 10. Department of Medical Oncology, Georges François Leclerc Center, Dijon, France. 11. Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom. 12. Department of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah. 13. Department of Hematology and Oncology, Barbara Ann Karmanos Cancer Center, Detroit, Michigan. 14. Department of Medical Oncology, Samuel and Barbara Sternberg Cancer Research Foundation, Rome, Italy. 15. Department of Medical Oncology, University Hospital of Lausanne, Lausanne, Switzerland. 16. Department of Medical Oncology, Foundation IRCCS National Cancer Institute, Milan, Italy. 17. Department of Oncology, Hospital Foch, Suresnes, France. 18. Division of Hematology and Oncology, Department of Medicine, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina. 19. Division of Genitourinary Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Abstract
BACKGROUND: Gemcitabine plus cisplatin (GC) has been adopted as a neoadjuvant regimen for muscle-invasive bladder cancer despite the lack of Level I evidence in this setting. METHODS: Data were collected using an electronic data-capture platform from 28 international centers. Eligible patients had clinical T-classification 2 (cT2) through cT4aN0M0 urothelial cancer of the bladder and received neoadjuvant GC or methotrexate, vinblastine, doxorubicin, plus cisplatin (MVAC) before undergoing cystectomy. Logistic regression was used to compute propensity scores as the predicted probabilities of patients being assigned to MVAC versus GC given their baseline characteristics. These propensity scores were then included in a new logistic regression model to estimate an adjusted odds ratio comparing the odds of attaining a pathologic complete response (pCR) between patients who received MVAC and those who received GC. RESULTS: In total, 212 patients (146 patients in the GC cohort and 66 patients in the MVAC cohort) met criteria for inclusion in the analysis. The majority of patients in the MVAC cohort (77%) received dose-dense MVAC. The median age of patients was 63 years, they were predominantly men (74%), and they received a median of 3 cycles of neoadjuvant chemotherapy. The pCR rate was 29% in the MVAC cohort and 31% in the GC cohort. There was no significant difference in the pCR rate when adjusted for propensity scores between the 2 regimens (odds ratio, 0.91; 95% confidence interval, 0.48-1.72; P = .77). In an exploratory analysis evaluating survival, the hazard ratio comparing hazard rates for MVAC versus GC adjusted for propensity scores was not statistically significant (hazard ratio, 0.78; 95% confidence interval, 0.40-1.54; P = .48). CONCLUSIONS: Patients who received neoadjuvant GC and MVAC achieved comparable pCR rates in the current analysis, providing evidence to support what has become routine practice.
BACKGROUND:Gemcitabine plus cisplatin (GC) has been adopted as a neoadjuvant regimen for muscle-invasive bladder cancer despite the lack of Level I evidence in this setting. METHODS: Data were collected using an electronic data-capture platform from 28 international centers. Eligible patients had clinical T-classification 2 (cT2) through cT4aN0M0 urothelial cancer of the bladder and received neoadjuvant GC or methotrexate, vinblastine, doxorubicin, plus cisplatin (MVAC) before undergoing cystectomy. Logistic regression was used to compute propensity scores as the predicted probabilities of patients being assigned to MVAC versus GC given their baseline characteristics. These propensity scores were then included in a new logistic regression model to estimate an adjusted odds ratio comparing the odds of attaining a pathologic complete response (pCR) between patients who received MVAC and those who received GC. RESULTS: In total, 212 patients (146 patients in the GC cohort and 66 patients in the MVAC cohort) met criteria for inclusion in the analysis. The majority of patients in the MVAC cohort (77%) received dose-dense MVAC. The median age of patients was 63 years, they were predominantly men (74%), and they received a median of 3 cycles of neoadjuvant chemotherapy. The pCR rate was 29% in the MVAC cohort and 31% in the GC cohort. There was no significant difference in the pCR rate when adjusted for propensity scores between the 2 regimens (odds ratio, 0.91; 95% confidence interval, 0.48-1.72; P = .77). In an exploratory analysis evaluating survival, the hazard ratio comparing hazard rates for MVAC versus GC adjusted for propensity scores was not statistically significant (hazard ratio, 0.78; 95% confidence interval, 0.40-1.54; P = .48). CONCLUSIONS:Patients who received neoadjuvant GC and MVAC achieved comparable pCR rates in the current analysis, providing evidence to support what has become routine practice.
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Authors: Alberto Martini; Rachel Jia; Bart S Ferket; Nikhil Waingankar; Elizabeth R Plimack; Simon J Crabb; Lauren C Harshman; Evan Y Yu; Thomas Powles; Jonathan E Rosenberg; Sumanta K Pal; Ulka N Vaishampayan; Andrea Necchi; N Peter Wiklund; Reza Mehrazin; Madhu Mazumdar; John P Sfakianos; Matthew D Galsky Journal: Cancer Date: 2019-05-31 Impact factor: 6.860
Authors: Homayoun Zargar; Jay B Shah; Elisabeth E Fransen van de Putte; Kylea R Potvin; Kamran Zargar-Shoshtari; Bas W van Rhijn; Siamak Daneshmand; Jeff M Holzbeierlein; Philippe E Spiess; Eric Winquist; Simon Horenblas; Colin Dinney; Peter C Black; Wassim Kassouf Journal: World J Urol Date: 2017-06-17 Impact factor: 4.226