REAL-WORLD TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER TREATED WITH RADICAL CYSTECTOMY BY CISPLATIN ELIGIBILITY STATUS: A US MULTICENTER CHART REVIEW STUDY
Author(s)
Jennifer J. Stuart, ScD1, Matthew D. Galsky, MD2, Mark L. Gonzalgo, MD, PhD3, Hristos Z. Kaimakliotis, MD4, Jen-Jane Liu, MD5, Ronac Mamtani, MD6, Sima P. Porten, MD, MPH7, Neal D Shore8, M. Minhaj Siddiqui, MD9, Patrick J. Squires, PharmD, PhD10, Blanca Homet Moreno, MD10, Mehmet Burcu, PhD10;
1Merck & Co., Inc, Principal Scientist, Rahway, NJ, USA, 2Icahn School of Medicine at Mount Sinai, Division of Hematology and Medical Oncology, Tisch Cancer Institute, New York, NY, USA, 3University of Miami, Miller School of Medicine, Desai Sethi Urology Institute, Miami, FL, USA, 4Indiana University, Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, USA, 5Oregon Health & Science University, Department of Urology, Portland, OR, USA, 6University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA, USA, 7University of California, San Francisco, Department of Urology, San Francisco, CA, USA, 8Myrtle Beach, SC, USA, 9University of Maryland School of Medicine, Baltimore, MD, USA, Division of Urology, Department of Surgery, Baltimore, MD, USA, 10Merck & Co., Inc., Rahway, NJ, USA
1Merck & Co., Inc, Principal Scientist, Rahway, NJ, USA, 2Icahn School of Medicine at Mount Sinai, Division of Hematology and Medical Oncology, Tisch Cancer Institute, New York, NY, USA, 3University of Miami, Miller School of Medicine, Desai Sethi Urology Institute, Miami, FL, USA, 4Indiana University, Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, USA, 5Oregon Health & Science University, Department of Urology, Portland, OR, USA, 6University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA, USA, 7University of California, San Francisco, Department of Urology, San Francisco, CA, USA, 8Myrtle Beach, SC, USA, 9University of Maryland School of Medicine, Baltimore, MD, USA, Division of Urology, Department of Surgery, Baltimore, MD, USA, 10Merck & Co., Inc., Rahway, NJ, USA
OBJECTIVES: Patients with muscle-invasive bladder cancer (MIBC) remain at substantial risk for recurrence after radical cystectomy (RC), with particularly poor outcomes among those who are ineligible for cisplatin-based chemotherapy. Real-world evidence describing treatment patterns and outcomes in these subgroups is limited. We assessed clinical characteristics, treatment patterns, outcomes, and the correlation of real-world event-free-survival (rw-EFS) with overall survival (OS) in patients with MIBC undergoing RC stratified by cisplatin-eligibility.
METHODS: A retrospective chart review was conducted across 8 US academic medical centers. Adults with MIBC who underwent RC from 01Jan2009-31Dec2018 were included and classified as cisplatin-eligible or -ineligible based on Galsky criteria. Descriptive analyses summarized characteristics and outcomes of interest. Kendall’s tau, using Clayton and Gumbel copula models, assessed the rw-EFS-OS association.
RESULTS: The cohort included 430 patients (cisplatin-eligible: n=373; cisplatin-ineligible: n=57). Median age was 67.0 years (cisplatin-eligible: 66.0 y; cisplatin-ineligible: 72.0 y), most were male (76.7%), White (85.8%), and had ≥1 comorbidity (90.2%). At surgery, 37.5% of cisplatin-eligible patients and 56.7% of cisplatin-ineligible patients had pT3 or pT4 disease. Among patients who received neoadjuvant therapy (cisplatin-eligible: 65.4%; cisplatin-ineligible: 24.6%), the pCR rates were 31.9% (74/232) and 15.4% (2/13), respectively. Median rw-EFS, metastatic disease-free survival, and OS were 85.3, 80.9, and 113.1 months, respectively, for cisplatin-eligible patients, and 33.6, 38.9, and 58.1 months, respectively, for cisplatin-ineligible patients. Across models, rw-EFS was associated with OS (Clayton Kendall’s Tau: 0.786 [95% CI: 0.739, 0.835]; Gumbel Kendall’s Tau: 0.760 [95% CI: 0.708, 0.811]), with consistent subgroup analyses.
CONCLUSIONS: In this multicenter, real-world, RC-treated MIBC cohort, cisplatin-ineligible patients had lower receipt of neoadjuvant therapy, higher pathologic stage at surgery, and poorer outcomes compared to cisplatin-eligible patients. rw-EFS demonstrated a strong patient-level correlation with OS across cisplatin-eligibility strata. These findings help establish a contemporary benchmark of treatment patterns and outcomes preceding recent approvals.
METHODS: A retrospective chart review was conducted across 8 US academic medical centers. Adults with MIBC who underwent RC from 01Jan2009-31Dec2018 were included and classified as cisplatin-eligible or -ineligible based on Galsky criteria. Descriptive analyses summarized characteristics and outcomes of interest. Kendall’s tau, using Clayton and Gumbel copula models, assessed the rw-EFS-OS association.
RESULTS: The cohort included 430 patients (cisplatin-eligible: n=373; cisplatin-ineligible: n=57). Median age was 67.0 years (cisplatin-eligible: 66.0 y; cisplatin-ineligible: 72.0 y), most were male (76.7%), White (85.8%), and had ≥1 comorbidity (90.2%). At surgery, 37.5% of cisplatin-eligible patients and 56.7% of cisplatin-ineligible patients had pT3 or pT4 disease. Among patients who received neoadjuvant therapy (cisplatin-eligible: 65.4%; cisplatin-ineligible: 24.6%), the pCR rates were 31.9% (74/232) and 15.4% (2/13), respectively. Median rw-EFS, metastatic disease-free survival, and OS were 85.3, 80.9, and 113.1 months, respectively, for cisplatin-eligible patients, and 33.6, 38.9, and 58.1 months, respectively, for cisplatin-ineligible patients. Across models, rw-EFS was associated with OS (Clayton Kendall’s Tau: 0.786 [95% CI: 0.739, 0.835]; Gumbel Kendall’s Tau: 0.760 [95% CI: 0.708, 0.811]), with consistent subgroup analyses.
CONCLUSIONS: In this multicenter, real-world, RC-treated MIBC cohort, cisplatin-ineligible patients had lower receipt of neoadjuvant therapy, higher pathologic stage at surgery, and poorer outcomes compared to cisplatin-eligible patients. rw-EFS demonstrated a strong patient-level correlation with OS across cisplatin-eligibility strata. These findings help establish a contemporary benchmark of treatment patterns and outcomes preceding recent approvals.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
P56
Topic
Epidemiology & Public Health
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology