Radiation and Radical Cystectomy Yield Similar OS in Node+ Bladder Cancer

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Real-world data suggest that the presence of pelvic lymphadenopathy should not be viewed as a contraindication to trimodality therapy in nonmetastatic clinically node-positive bladder cancer.

"Patients who present with [nonmetastatic clinically node-positive bladder cancer] have a poor prognosis and should be counseled as to the most appropriate treatment, empowering them in their decision making with the knowledge that bladder preservation is a real alternative to radical surgery," according to the study authors.

"Patients who present with [nonmetastatic clinically node-positive bladder cancer] have a poor prognosis and should be counseled as to the most appropriate treatment, empowering them in their decision making with the knowledge that bladder preservation is a real alternative to radical surgery," according to the study authors.

There were no differences in overall survival (OS) or progression-free survival (PFS) outcomes between patients with nonmetastatic, clinically node-positive bladder cancer who received bladder-sparing trimodality therapy or radical cystectomy, according to findings from a real-world study published in Journal of Clinical Oncology.

Among 287 patients who were included in the survival analysis, the median OS was 1.55 years (95% CI, 1.35-1.82). The 2-year and 5-year OS rates, respectively, were 39% (95% CI, 34%-45%) and 19% (95% CI, 15%-25%). The median PFS in the overall cohort was 0.95 years (95% CI, 0.89-1.13). PFS rates at 2 and 5 years, respectively, were 28% (95% CI, 23%-34%) and 17% (95% CI, 12%-22%).

Radical treatment correlated with improved OS relative to palliative treatment (HR, 0.30; 95% CI, 0.23-0.39; P <.0001), and investigators noted a similar improvement with respect to PFS (HR, 0.36; 95% CI, 0.27-0.46; P <.0001). Among 163 patients receiving radical treatment, the median OS was 2.4 years (95% CI, 1.9-2.8), and the 2-year OS rate was 56% (95% CI, 48%-64%). The corresponding values for 124 patients receiving palliative treatment were 0.89 years (95% CI, 0.67-1.1) and 18% (95% CI, 12%-26%). The median PFS in those receiving radical and palliative treatment, respectively, was 1.5 years (95% CI, 1.3-2.0) and 0.63 years (95% CI, 0.43-0.77).

The median OS was 2.53 years (95% CI, 2.02-3.44) in patients receiving radical dose radiotherapy vs 2.09 years (95% CI, 1.79-3.13) for those receiving radical cystectomy. The 2-year OS rates in each respective group were 60% (95% CI, 50%-72%) and 51% (95% CI, 40%-64%). Investigators reported a median PFS of 1.93 years (95% CI, 1.41-2.71) in the radiotherapy arm vs 1.22 (95% CI, 0.90-1.85) in the cystectomy group.

Investigators reported that receipt of radiotherapy vs cystectomy did not correlate with OS (HR, 0.94; 95% CI, 0.63-1.41; P = .76) or PFS (HR, 0.74; 95% CI, 0.50-1.08; P = .12) based on multivariate analysis. Additionally, receiving chemotherapy correlated with improvements in OS (HR, 0.53; 95% CI, 0.32-0.87; P = .011) and PFS (HR, 0.43; 95% CI, 0.27-0.69; P <.01). Having a higher clinical node status also correlated with lower OS (HR, 1.72; 95% CI, 1.07-2.76), and PFS (HR, 1.82; 95% CI, 1.18-2.81; P = .007).

“Level 1/2 evidence comparing [radical dose radiotherapy with radical cystectomy] is unlikely to emerge, given that attempts to randomize between [radical cystectomy] and [radical dose radiotherapy] have been unsuccessful,” the study authors wrote.

“Although our study has limitations, it provides important evidence for those patients with [nonmetastatic clinically node-positive bladder cancer] considering a bladder-sparing alternative to [radical cystectomy]…. Patients who present with [nonmetastatic clinically node-positive bladder cancer] have a poor prognosis and should be counseled as to the most appropriate treatment, empowering them in their decision making with the knowledge that bladder preservation is a real alternative to radical surgery.”

Investigators of this real-world study assessed data from patients who were diagnosed with clinically node-positive nonmetastatic bladder cancer from 2012 to 2021 at 4 oncology centers in the United Kingdom. The study included 5 radical-type treatment groups: systemic anticancer therapy plus radical cystectomy, cystectomy alone, systemic anticancer therapy plus radical dose radiotherapy, radical dose radiotherapy alone, and cystectomy plus adjuvant radiotherapy.

Estimations of OS and PFS involved the Kaplan-Meier method. Patients with metastatic disease as confirmed via pelvic and abdominal CT scan and either thoracic CT or x-ray were not eligible for inclusion in the study.

The median follow-up was 4.53 years (95% CI, 4.19-5.81). In the overall patient population, the median age was 71 years (interquartile range, 63-77), and 72% of patients were male. Additionally, most patients had an ECOG performance status of 0 (35.5%), pure urothelial histology (81.5%), poorly differentiated tumors (92.7%), and were current or past smokers (58.8%).

Overall, 85 of 87 patients in the radical dose radiotherapy group received all planned fractions of treatment. Of these patients, radiotherapy was administered to the bladder alone in 59 and to the bladder and lymph nodes in 27. Additionally, 47 patients receiving radical dose radiotherapy were also treated with a radiosensitizer, which included concurrent chemotherapy in 35 and inhaled carbogen plus oral nicotinamide in 11.

The median OS in patients who received radical dose radiotherapy plus a radiosensitizer was 2.90 years (95% CI, 2.37-not evaluable [NE]) compared with 2.47 years (95% CI, 1.98-NE) in those who did not. Investigators reported no significant differences in OS outcomes based on a log-rank test (x2 = .4; P = .5). Additionally, the median PFS for patients receiving radiotherapy plus a radiosensitizer was 1.93 years (95% CI, 1.38-NE) compared with 2.47 years (95% CI, 1.60-NE) in those who did not receive a radiosensitizer (x2 = .1; P = .7).

Reference

Swinton M, Mariam NB, Tan JL, et al. Bladder-sparing treatment with radical dose radiotherapy is an effective alternative to radical cystectomy in patients with clinically node-positive nonmetastatic bladder cancer. J Clin Oncol. Published online July 21, 2023. doi:10.1200/JCO.23.00725

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