Real-world treatment patterns and clinical outcomes with first-line therapy in patients with locally advanced/metastatic urothelial carcinoma by cisplatin-eligibility.

INTRODUCTION: Patients with locally advanced/metastatic urothelial carcinoma (la/mUC) have a poor prognosis. With recent therapeutic advances, data on real-world treatment patterns and overall survival (OS) in patients with la/mUC treated with first-line therapy are limited, particularly when comparing patients who are cisplatin-ineligible versus cisplatin-eligible. METHODS: This was a retrospective observational study of real-world first-line treatment patterns and OS in patients with la/mUC stratified by cisplatin-eligibility and treatment. Data were from a nationwide electronic health record-derived de-identified database. Eligible patients were adults diagnosed with la/mUC from May 2016 to April 2021 and followed until death or end of data availability in January 2022. OS stratified by first-line treatment and cisplatin eligibility was estimated using Kaplan-Meier methods and compared via multivariable Cox proportional-hazard models adjusted for clinical covariates. RESULTS: Of 4,757 patients with la/mUC, 3,632 (76.4%) received first-line treatment, with 2,029 (55.9%) cisplatin-ineligible and 1,603 (44.1%) cisplatin-eligible. Patients who were cisplatin-ineligible were older (mean age, 74.9 vs. 68.8 years) and had lower CrCl (median, 46.4 vs. 87.0 ml/min). Only 43.8% of patients receiving first-line treatment (37.6% cisplatin-ineligible vs. 51.6% cisplatin-eligible) received second-line therapy. Median OS in all patients receiving first-line treatment was 10.8 (95% CI, 10.2-11.3) months and was shorter in patients who were cisplatin-ineligible than cisplatin-eligible (8.5 [95% CI, 7.8-9.0] vs. 14.4 [13.3-16.1]; hazard ratio [HR], 0.9 [0.7-1.1]). Cisplatin-based therapy was associated with longer OS (17.6 [15.1-20.4] months) than other first-line treatments (the shortest OS was with PD-1/L1 inhibitor monotherapy; 7.7 [6.8-8.8] months), including among patients who were classified as cisplatin-ineligible. CONCLUSIONS: Outcomes for patients with newly diagnosed la/mUC are poor, particularly for patients who are cisplatin-ineligible and/or do not receive cisplatin-based therapy. Many patients with la/mUC did not receive first-line treatment and among those who did, fewer than half received second-line therapy. These data highlight the need for more effective first-line therapies for all patients with la/mUC.

Treatment with opioids in patients with locally advanced or metastatic urothelial carcinoma and matched non-cancer controls.

BACKGROUND: Locally advanced or metastatic urothelial carcinoma (la/mUC) is an aggressive disease with a poor long-term survival. While patients frequently report pain, there are limited data on the patient experience with pain and pain medication use. This study used real-world data to quantify treatment with opioids, as a proxy for pain, in patients with la/mUC compared with matched non-cancer controls. METHODS: This was a retrospective claims analysis, using the IBM® MarketScan® databases, of adults diagnosed with urothelial carcinoma and initiating ≥1 la/mUC therapy between May 2016 and June 2019. Index date was date of first systemic therapy claim for la/mUC; baseline was the 6 months pre-index; follow-up was from index until disenrollment or study end. Proportion with treatment with opioids, number of opioid prescriptions, and daily morphine-equivalent dose (MEQ; in morphine milligram equivalents/day) in patients with la/mUC and matched non-cancer controls from the same databases were assessed. RESULTS: We identified 1293 patients with la/mUC and matched 1:3 with 3862 non-cancer controls. Mean (SD) follow-up was 1.26 (0.74) years in patients with la/mUC and 1.29 (0.72) years in controls. A greater proportion of patients with la/mUC, compared with controls, used opioids during both baseline (63.6% vs. 19.4%) and follow-up (61.4% vs. 27.9%). Among those who used opioids, mean monthly prescriptions (number of medications claims/patient/month) were 0.55 both in patients with la/mUC and controls during baseline, and 0.49 and 0.39, respectively, at follow-up. Daily MEQ among those who used opioids was 53.6 and 45.7 during baseline, and 74.7 and 40.8 at follow-up, in patients with la/mUC and controls, respectively. In patients with la/mUC, mean opioid prescriptions and daily MEQ increased during later lines of therapy. CONCLUSION: In patients with la/mUC, pain requiring opioids is common at diagnosis, worsens as the patient progresses, and is consistently higher than in matched controls. Improvement in disease control with more effective therapies may reduce cancer pain in this population.