Comparing treatment modalities for T2N0M0 muscle invasive bladder cancer: A propensity score analysis with the National Cancer Database.

person Alberto Pieretti Cleveland Clinic Florida, Weston Hospital, Weston, FL info_outline Alberto Pieretti, Mohamed Mohanna, Saad Sabbagh, Nicolas Muruve, Hong Liang, Christopher Fleming, Christopher Weight, Nima Almassi, Georges-Pascal Haber, Ashish M. Kamat, Rafael Arteta-Bulos, Colin P.N. Dinney

Authors person Alberto Pieretti Cleveland Clinic Florida, Weston Hospital, Weston, FL info_outline Alberto Pieretti, Mohamed Mohanna, Saad Sabbagh, Nicolas Muruve, Hong Liang, Christopher Fleming, Christopher Weight, Nima Almassi, Georges-Pascal Haber, Ashish M. Kamat, Rafael Arteta-Bulos, Colin P.N. Dinney Organizations Cleveland Clinic Florida, Weston Hospital, Weston, FL, Maroone Cancer Center, Cleveland Clinic Florida, Weston, FL, Cleveland Clinic Florida, Research Department, Weston, FL, Cleveland Clinic Florida, Department of Radiation Oncology, Cleveland, OH, Cleveland Clinic Glickman Urology and Kidney Institute, Cleveland, OH, The University of Texas MD Anderson Cancer Center, Houston, TX Abstract Disclosures Research Funding No funding sources reported Background: Muscle-invasive Bladder Cancer (MIBC) constitutes 25% of bladder malignancies. Per NCCN guidelines, the primary treatment for stage II (T2N0M0) MIBC is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC), RC alone, or bladder preservation chemoradiotherapy (BPCRT). This study aims to compare the overall survival between different treatment modalities with an emphasis on patients considered to be best candidates for BPCRT (No hydronephrosis, extensive or multifocal carcinoma in situ (CIS), and tumor size <6cm, ”low-risk”) versus those who are not (“high-risk”). Methods: We queried 12510 patients from the National Cancer Database from 2004-2020 for stage II T2N0M0 MIBC. Patients were divided in low-risk (< 6 cm and no evidence of CIS) or high-risk MIBC. The propensity score matched (PSM) sample was constructed greedy nearest neighbor matching on the logit of the propensity score using a caliper of width equal to 0.2 of the standard deviation of the logit of the propensity score. We used standardized differences (SD) to evaluate how well the covariates were balanced and a value of < 0.1 was considered negligible. The Cox proportional hazards model was performed to compare the survivorships between the PSM paired samples. All data analyses were conducted using SAS version 9.4. Results: Following PSM and risk factor stratification, we found that median overall survival (OS) was lower with BPRCT compared to RC alone or NAC+RC in both risk groups. In the low-risk group, the median OS of BPRCT compared to NAC+RC was 34 and 76 months, respectively (HR = 1.81, 95%CI = (1.25-2.62), p=0.0017 and there was no statistical significant difference in RC compared to NAC+RC median OS (p=0.3459). In the high-risk group, the median OS of BPRCT compared to NAC+RC was 22 and 68 months, respectively (HR = 2.19, 95%CI = (1.86-2.59), p<0.0001) (Table) and the median OS of RC compared to NAC+RC was 79 and 99 months respectively (HR=1.2, 95%CI = (1.11-1.3), p<0.001 (Table). Conclusions: This nationwide study showed that RC was the optimal treatment for low-risk stage 2 MIBC, with improved OS compared with BPCRT and equivalent OR with NAC+RC, without the added cost or morbidity. For high-risk patients NAC+RC was associated with a significant improvement of OS compared to BPCRT and RC alone. Survival comparison of different treatment modalities. HR 95%CI p-value (1) RC vs. NAC+RC for whole patients 1.23 (1.15-1.31) <0.0001 (1.1) RC vs. NAC+RC for patients with tumor size > 6 cm and/or CIS 1.20 (1.11-1.30) <0.0001 (1.2) RC vs. NAC+RC for patients with tumor size ≤ 6 cm and no-CIS 1.10 (0.90-1.33) 0.3459 (2) BPCRT vs. NAC+RC for whole patients 1.95 (1.70-2.25) <0.0001 (2.1) BPCRT vs. NAC+RC for patients with tumor size > 6 cm and/or CIS 2.19 (1.86-2.59) <0.0001 (2.2) BPCRT vs. NAC+RC for patients with tumor size ≤ 6 cm and no-CIS 1.81 (1.25-2.62) 0.0017