Division of Hematology/Oncology, Department of Medicine, Feinberg School of Medicine at Northwestern University, Chicago, IL.
Seagen Inc., Bothell, WA.
Urol Oncol. 2021 Oct;39(10):733.e1-733.e10. doi: 10.1016/j.urolonc.2021.05.001. Epub 2021 Jul 5.
Several programmed death-1 or death-ligand 1 (PD-1/L1) inhibitors are approved first- or second-line therapies for locally advanced or metastatic urothelial carcinoma (la/mUC); however, clinical trials show that only ∼20% of patients respond and all ultimately progress. This study elucidated real-world treatment patterns, healthcare resource utilization (HRU), and economic burden among Medicare beneficiaries with la/mUC who discontinue PD-1/L1 inhibitor therapies.
We conducted a retrospective claims analysis of patients aged ≥65 years diagnosed with la/mUC (2015-2017) who initiated and subsequently discontinued PD-1/L1 inhibitor therapy (index=date of last administration) using Medicare Fee-for-Service Research Identifiable Files. Included patients had ≥12 months pre- and ≥3 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or data cutoff.
Among 28,063 patients, 17% (n=4652) received ≥1 PD-1/L1 inhibitor following la/mUC diagnosis. Of these, 791 discontinued PD-1/L1 inhibitor therapy and met inclusion criteria (study cohort); 73% male, median age 76 years. Post-discontinuation, 3% received a different PD-1/L1 inhibitor, 46% chemotherapy, and 51% no further systemic treatment. HRU was high during follow-up: 97% had ≥1 outpatient visit and 52% ≥1 hospitalization. Healthcare costs per-patient-per-month were $7153 pre- and $7745 (adjusted) post-index; systemic therapy costs were higher pre- vs. post-index ($2978 vs. $1195) but other costs were higher post-index: hospitalization ($1120 vs. $2200), outpatient ($1437 vs. $2064), hospice ($3 vs. $536), skilled nursing facility ($106 vs. $384).
Over half of Medicare beneficiaries with la/mUC received no disease-directed therapy post-PD-1/L1 inhibitor treatment. Patients who discontinued PD-1/L1 inhibitor therapy had intensive HRU unrelated to therapy costs, highlighting the significant burden of la/mUC and need for treatments that extend survival.
几种程序性死亡受体-1 或死亡配体 1（PD-1/L1）抑制剂已被批准用于局部晚期或转移性尿路上皮癌（la/mUC）的一线或二线治疗；然而，临床试验表明，只有约 20%的患者有反应，所有患者最终都会进展。本研究阐明了医疗保险受益人的真实世界治疗模式、医疗资源利用（HRU）和经济负担，这些患者因 la/mUC 停止 PD-1/L1 抑制剂治疗。
我们使用医疗保险付费服务研究可识别文件，对 2015-2017 年诊断为 la/mUC（年龄≥65 岁）并随后停止 PD-1/L1 抑制剂治疗（索引=最后一次给药日期）的患者进行了回顾性索赔分析。纳入的患者在索引前有≥12 个月的连续医疗保险登记，在索引后有≥3 个月的连续医疗保险登记，并随访至退出、死亡或数据截止。
在 28063 名患者中，17%（n=4652）在 la/mUC 诊断后接受了≥1 种 PD-1/L1 抑制剂治疗。其中，791 名患者停止了 PD-1/L1 抑制剂治疗并符合纳入标准（研究队列）；73%为男性，中位年龄为 76 岁。停药后，3%的患者接受了另一种 PD-1/L1 抑制剂治疗，46%的患者接受了化疗，51%的患者未接受进一步的系统治疗。在随访期间，HRU 很高：97%的患者至少有 1 次门诊就诊，52%的患者至少有 1 次住院治疗。每位患者每月的医疗保健费用在索引前为 7153 美元，在索引后为 7745 美元（调整后）；系统治疗费用在索引前比索引后高（2978 美元比 1195 美元），但其他费用在索引后更高：住院治疗（1120 美元比 2200 美元）、门诊（1437 美元比 2064 美元）、临终关怀（3 美元比 536 美元）、熟练护理机构（106 美元比 384 美元）。
超过一半的医疗保险受益人的 la/mUC 患者在停止 PD-1/L1 抑制剂治疗后未接受疾病定向治疗。停止 PD-1/L1 抑制剂治疗的患者接受了与治疗费用无关的密集 HRU，突出了 la/mUC 的显著负担和需要延长生存的治疗方法。
