Dataset Information

National Cancer Database Comparison of Radical Cystectomy vs Chemoradiotherapy for Muscle-Invasive Bladder Cancer: Implications of Using Clinical vs Pathologic Staging.

ABSTRACT:

Purpose

To test the hypothesis that bladder preservation therapy consisting of definitive chemoradiotherapy (chemoRT) results in similar overall survival rates to radical cystectomy/chemotherapy when balancing baseline patient characteristics and initial (preoperative) clinical stage.

Materials/methods

A total of 7,322 patients with stage II-IV, M0 bladder cancer who were treated with cystectomy/chemo (N = 5,664) or definitive chemoRT (N = 1,658) were identified from the National Cancer Database. Baseline patient characteristics were compared using Pearson's chi-square, Fisher's exact test, and Wilcoxon's rank sum tests. Cox regressions were used to investigate for variables significantly correlated with overall survival (OS). OS was compared between cystectomy/chemo vs chemoRT before and after propensity score matched pair analyses using Kaplan-Meier curves and log-rank tests.

Results

Patients who underwent cystectomy/chemo were significantly younger than ones treated with definitive chemoRT (mean age 63.7 vs 75.2; P < 0.001). Age, race, Charlson/Deyo Comorbidity Score (CDCS), clinical stage, insurance status, and type of facility significantly correlated with OS (P < 0.05 for all covariates). Patients treated with cystectomy/chemo were younger, healthier with better CDCS, and more likely treated at academic facilities. Before matched pair analyses, OS was significantly better when treated with cystectomy/chemo (3 year 56.4%; 5 year 45.9%) compared to chemoRT (3 year 47.3%; 5 year 33.2%) (P < 0.001); 28.6% of patients undergoing cystectomy were upstaged at the time of surgery. After matched pair analyses matching age, race, sex, CDCS, clinical (presurgical) stage, insurance, and facility type (N = 1,750), OS was no longer significantly different between cystectomy/chemo (3 year 52.1% and 5 year 41.0%) vs chemoRT (3 year 53.3% and 5 year 40.1%) (P = 0.5).

Conclusions

Patients treated with cystectomy/chemo were significantly younger and healthier compared to those treated with chemoRT. Once these factors were accounted for in propensity score matched pair analyses using clinical stage, overall survival was not significantly different between cystectomy/chemo and an organ-sparing approach with definitive chemoRT.

SUBMITTER: Lin HY

PROVIDER: S-EPMC6247074 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

National Cancer Database Comparison of Radical Cystectomy vs Chemoradiotherapy for Muscle-Invasive Bladder Cancer: Implications of Using Clinical vs Pathologic Staging.

Lin Hong-Yiou HY Ye Hong H Kernen Kenneth M KM Hafron Jason M JM Krauss Daniel J DJ

Cancer medicine 20181010 11

<h4>Purpose</h4>To test the hypothesis that bladder preservation therapy consisting of definitive chemoradiotherapy (chemoRT) results in similar overall survival rates to radical cystectomy/chemotherapy when balancing baseline patient characteristics and initial (preoperative) clinical stage.<h4>Materials/methods</h4>A total of 7,322 patients with stage II-IV, M0 bladder cancer who were treated with cystectomy/chemo (N = 5,664) or definitive chemoRT (N = 1,658) were identified from the National ...[more]

PMID: 30306728

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Project description:ImportanceThe value to payers of robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) when compared with open radical cystectomy (ORC) for patients with bladder cancer is unclear.ObjectivesTo compare the cost-effectiveness of iRARC with that of ORC.Design, setting, and participantsThis economic evaluation used individual patient data from a randomized clinical trial at 9 surgical centers in the United Kingdom. Patients with nonmetastatic bladder cancer were recruited from March 20, 2017, to January 29, 2020. The analysis used a health service perspective and a 90-day time horizon, with supplementary analyses exploring patient benefits up to 1 year. Deterministic and probabilistic sensitivity analyses were undertaken. Data were analyzed from January 13, 2022, to March 10, 2023.InterventionsPatients were randomized to receive either iRARC (n = 169) or ORC (n = 169).Main outcomes and measuresCosts of surgery were calculated using surgery timings and equipment costs, with other hospital data based on counts of activity. Quality-adjusted life-years were calculated from European Quality of Life 5-Dimension 5-Level instrument responses. Prespecified subgroup analyses were undertaken based on patient characteristics and type of diversion.ResultsA total of 305 patients with available outcome data were included in the analysis, with a mean (SD) age of 68.3 (8.1) years, and of whom 241 (79.0%) were men. Robot-assisted radical cystectomy was associated with statistically significant reductions in admissions to intensive therapy (6.35% [95% CI, 0.42%-12.28%]), and readmissions to hospital (14.56% [95% CI, 5.00%-24.11%]), but increases in theater time (31.35 [95% CI, 13.67-49.02] minutes). The additional cost of iRARC per patient was £1124 (95% CI, -£576 to £2824 [US $1622 (95% CI, -$831 to $4075)]) with an associated gain in quality-adjusted life-years of 0.01124 (95% CI, 0.00391-0.01857). The incremental cost-effectiveness ratio was £100 008 (US $144 312) per quality-adjusted life-year gained. Robot-assisted radical cystectomy had a much higher probability of being cost-effective for subgroups defined by age, tumor stage, and performance status.Conclusions and relevanceIn this economic evaluation of surgery for patients with bladder cancer, iRARC reduced short-term morbidity and some associated costs. While the resulting cost-effectiveness ratio was in excess of thresholds used by many publicly funded health systems, patient subgroups were identified for which iRARC had a high probability of being cost-effective.Trial registrationClinicalTrials.gov Identifier: NCT03049410.

Project description:ImportanceEarlier studies on the cost of muscle-invasive bladder cancer treatments lack granularity and are limited to 180 days.ObjectiveTo compare the 1-year costs associated with trimodal therapy vs radical cystectomy, accounting for survival and intensity effects on total costs.Design, setting, and participantsThis population-based cohort study used the US Surveillance, Epidemiology, and End Results-Medicare database and included 2963 patients aged 66 to 85 years who had received a diagnosis of clinical stage T2 to T4a muscle-invasive bladder cancer from January 1, 2002, through December 31, 2011. The data analysis was performed from March 5, 2018, through December 4, 2018.Main outcomes and measuresTotal Medicare costs within 1 year of diagnosis following radical cystectomy vs trimodal therapy were compared using inverse probability of treatment-weighted propensity score models that included a 2-part estimator to account for intrinsic selection bias.ResultsOf 2963 participants, 1030 (34.8%) were women, 2591 (87.4%) were white, 129 (4.4%) were African American, and 98 (3.3%) were Hispanic. Median costs were significantly higher for trimodal therapy than radical cystectomy in 90 days ($83 754 vs $68 692; median difference, $11 805; 95% CI, $7745-$15 864), 180 days ($187 162 vs $109 078; median difference, $62 370; 95% CI, $55 581-$69 160), and 365 days ($289 142 vs $148 757; median difference, $109 027; 95% CI, $98 692-$119 363), respectively. Outpatient care, radiology, medication expenses, and pathology/laboratory costs contributed largely to the higher costs associated with trimodal therapy. On inverse probability of treatment-weighted adjusted analyses, patients undergoing trimodal therapy had $136 935 (95% CI, $122 131-$152 115) higher mean costs compared with radical cystectomy 1 year after diagnosis.Conclusions and relevanceCompared with radical cystectomy, trimodal therapy was associated with higher costs among patients with muscle-invasive bladder cancer. The differences in costs were largely attributed to medication and radiology expenses associated with trimodal therapy. Extrapolating cost figures resulted in a nationwide excess spending of $468 million for trimodal therapy compared with radical cystectomy for patients who received a diagnosis of bladder cancer in 2017.

Project description:BackgroundMuscle-invasive bladder cancer (MIBC) remains undertreated despite multiple potentially curative options. Both radical cystectomy (RC) with or without neoadjuvant chemotherapy and trimodal therapy (TMT), including transurethral resection of bladder tumor followed by chemoradiotherapy, are standard treatments.ObjectiveTo evaluate real-world clinical outcomes of RC with neoadjuvant chemotherapy (RC-NAC), RC without NAC, TMT with National Comprehensive Cancer Network guideline-preferred radiosensitizing chemotherapy including cisplatin or mitomycin-C and 5-fluorouracil (pTMT), and TMT with nonpreferred chemotherapy (npTMT).Design setting and participantsUS veterans with nonmetastatic MIBC (T2-4aN0-3M0) were studied.Outcome measurements and statistical analysisOverall mortality (OM) was evaluated with multivariable Cox proportional hazard model. Bladder cancer-specific mortality (BCSM) was evaluated with multivariable Fine-Gray regression. Salvage cystectomy rates were obtained by chart review.Results and limitationsOverall 2306 patients were included: 1472 (64%) with RC without NAC, 506 (22%) with RC-NAC, 163 (7%) with pTMT, and 165 (7%) with npTMT. On multivariable analysis, pTMT was associated with similar OM (hazard ratio [HR] 1.19; 95% confidence interval [CI] 0.94-1.50; p = 0.15) and BCSM (HR 1.34; 95% CI 0.99-1.83; p = 0.06) to RC-NAC; npTMT was associated with worse OM (HR 1.30; 95% CI 1.04-1.61; p = 0.02) and BCSM (HR 1.45; 95% CI 1.09-1.94; p = 0.01). RC without NAC was associated with similar OM (HR 1.08; 95% CI 0.95-1.24; p = 0.24) and BCSM (HR 1.02; 95% CI 0.86-1.21; p = 0.79). When stratified by age, among patients ≥65 yr of age, treatment with pTMT was associated with similar OM (HR 1.14; 95% CI 0.87-1.50; p = 0.35) and BCSM (HR 1.11; 95% CI 0.76-1.62; p = 0.60). Among patients <65 yr of age, pTMT was associated with worse OM (HR 1.82; 95% CI 1.14-2.91; p = 0.01) and BCSM (HR 2.51; 95% CI 1.52-4.13; p < 0.01). The 5-yr cumulative incidence of salvage cystectomy in the TMT group was 3.6%.ConclusionsIn MIBC, patients receiving pTMT have comparable survival in RC-NAC patients ≥65 yr and inferior survival in RC-NAC patients <65 yr. Salvage cystectomy rates were low.Patient summaryManagement of muscle-invasive bladder cancer is a multidisciplinary effort requiring thoughtful discussions with patients about treatment options, including trimodal therapy, which is an effective treatment option.

Project description:BackgroundNeo-adjuvant chemotherapy followed by radical cystectomy with extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. We hypothesize that postoperative adjuvant external beam radiotherapy (EBRT) might prevent local and lymph node recurrence and improve disease free- and overall survival as loco-regional recurrence is linked to the development of distant metastasis.MethodsWe plan to perform a multicentric prospective phase two study including 76 patients. Eligible patients are patients with MIBC, treated with radical cystectomy and presenting with ≥1 of the following characteristics: Pathological (p)T3 stage + presence of lymphovascular invasion on pathological examination pT4 stage <10 lymph nodes removed positive lymph nodes positive surgical margins Patients will have a 18F-FDG PET-CT to rule out the presence of distant metastasis prior to EBRT. A median dose of 50 Gy in 25 fractions is prescribed to the pelvic lymph node regions with inclusion of the operative bladder bed in case of a positive surgical margin. Patients with suspected lymph nodes on PET- CT can still be included in the trial, but a simultaneous integrated boost to 74Gy to the positive lymph nodes will be delivered. Blood and urine samples will be collected on day-1 and last day of EBRT for evaluation of biomarkers. The primary endpoint is evaluation of acute ≥Grade 3 intestinal or grade 4 urinary toxicity, in case of a neo-bladder reconstruction, within 12 weeks after EBRT. Secondary endpoints are: assessment of QOL, late RTOG toxicity, local control, disease free survival and overall survival. Biomarkers in urine and blood will be correlated with secondary survival endpoints.DiscussionThis is a prospective phase 2 trial re-assessing the feasibility of adjuvant radiotherapy in high-risk MIBC.Trial registrationThe Ethics committee of the Ghent University Hospital (EC2014/0630) approved this study on 31/07/2014. Trial registration on Clinicaltrials.gov ( NCT02397434 ) on November 19, 2014.

Dataset Information

National Cancer Database Comparison of Radical Cystectomy vs Chemoradiotherapy for Muscle-Invasive Bladder Cancer: Implications of Using Clinical vs Pathologic Staging.

Purpose

Materials/methods

Results

Conclusions

Publications

National Cancer Database Comparison of Radical Cystectomy vs Chemoradiotherapy for Muscle-Invasive Bladder Cancer: Implications of Using Clinical vs Pathologic Staging.

Similar Datasets

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