Thomas Seisen1, Maxine Sun1, Stuart R Lipsitz1, Firas Abdollah2, Jeffrey J Leow1, Mani Menon2, Mark A Preston1, Lauren C Harshman3, Adam S Kibel1, Paul L Nguyen4, Joaquim Bellmunt3, Toni K Choueiri3, Quoc-Dien Trinh5. 1. Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 2. Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA. 3. Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. 4. Department of Radiation Oncology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 5. Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: qtrinh@bwh.harvard.edu.
Abstract
Given the lack of randomized evidence comparing trimodal therapy (TMT) to radical cystectomy (RC) for muscle-invasive urothelial carcinoma of the bladder (UCB), we performed an observational cohort study to examine the comparative effectiveness of these two definitive treatments. Within the National Cancer Data Base (2004-2011),we identified 1257 (9.8%) and 11 586 (90.2%) patients who received TMT and RC, respectively. Inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier analysis showed that median overall survival (OS) was similar between the TMT (40 mo, 95% confidence interval [CI] 34-46) and RC groups (43 mo 95% CI 41-45; p=0.3). In IPTW-adjusted Cox regression analysis with a time-varying covariate, TMT was associated with a significant adverse impact on long-term OS (hazard ratio 1.37, 95% CI 1.16-1.59; p<0.001). Interaction terms indicated that the adverse treatment effect of TMT versus RC decreased with age (p=0.004), while there was no significant interaction with gender (p=0.6), Charlson comorbidity index (p=0.09) or cT stage (p=0.8). In conclusion, we found that TMT was generally associated with worse long-term OS compared to RC for muscle-invasive UCB. However, the survival benefit of RC should be weighed against the risks of surgery, especially in older patients. These results are preliminary and emphasize the need for a randomized controlled trial to compare TMT versus RC. PATIENT SUMMARY: We examined the comparative effectiveness of trimodal therapy versus radical cystectomy for muscle-invasive urothelial carcinoma of the bladder. We found that trimodal therapy was generally associated with worse long-term overall survival, although there may be no difference with radical cystectomy in older individuals.
Given the lack of randomized evidence comparing trimodal therapy (TMT) to radical cystectomy (RC) for muscle-invasive urothelial carcinoma of the bladder (UCB), we performed an observational cohort study to examine the comparative effectiveness of these two definitive treatments. Within the National Cancer Data Base (2004-2011),we identified 1257 (9.8%) and 11 586 (90.2%) patients who received TMT and RC, respectively. Inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier analysis showed that median overall survival (OS) was similar between the TMT (40 mo, 95% confidence interval [CI] 34-46) and RC groups (43 mo 95% CI 41-45; p=0.3). In IPTW-adjusted Cox regression analysis with a time-varying covariate, TMT was associated with a significant adverse impact on long-term OS (hazard ratio 1.37, 95% CI 1.16-1.59; p<0.001). Interaction terms indicated that the adverse treatment effect of TMT versus RC decreased with age (p=0.004), while there was no significant interaction with gender (p=0.6), Charlson comorbidity index (p=0.09) or cT stage (p=0.8). In conclusion, we found that TMT was generally associated with worse long-term OS compared to RC for muscle-invasive UCB. However, the survival benefit of RC should be weighed against the risks of surgery, especially in older patients. These results are preliminary and emphasize the need for a randomized controlled trial to compare TMT versus RC. PATIENT SUMMARY: We examined the comparative effectiveness of trimodal therapy versus radical cystectomy for muscle-invasive urothelial carcinoma of the bladder. We found that trimodal therapy was generally associated with worse long-term overall survival, although there may be no difference with radical cystectomy in older individuals.
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