The Royal Marsden NHS Foundation Trust, London, UK.
The Institute of Cancer Research, London, UK.
BMJ Open. 2024 Nov 24;14(11):e083540. doi: 10.1136/bmjopen-2023-083540.
This study defined a retrospective cohort of patients in England with primary advanced or recurrent (A/R) endometrial cancer (EC) who may have been eligible for clinical trials evaluating immune checkpoint inhibitors (ICIs) in the first-line (1L) setting within a real-world dataset, and described the characteristics, treatment patterns and outcomes within this cohort.
This was a retrospective, population-based study.
Routine population-level data from the National Cancer Registration and Analysis Service in England were used. Patients diagnosed with A/R EC between 1 January 2013 and 31 December 2019 were included (follow-up until 23 August 2021). ICI-eligible patients who received any 1L therapy (defined as first systemic treatment for A/R EC with or without radiotherapy) and met key eligibility criteria for the RUBY trial (NCT03981796; 1L cohort) were included. A subpopulation who solely received carboplatin-paclitaxel at 1L (carboplatin-paclitaxel subcohort) was identified.
Demographics, characteristics and therapy received were reported. Overall survival (OS), time to next treatment (TTNT) and time to treatment discontinuation (TTD) from 1L chemotherapy initiation were assessed using Kaplan-Meier methodology.
Of 13 954 patients identified, 2376 ICI-eligible patients were included in the 1L cohort (median [range] age: 67.9 [26.7-94.0] years); 902 patients received solely carboplatin-paclitaxel at 1L. Demographics and disease characteristics were generally similar between cohorts. Median (95% CI) OS, TTNT and TTD from 1L chemotherapy were 27.2 (24.7, 30.2), 16.9 (15.8, 18.5) and 3.4 (3.4, 3.4) months, respectively, in the 1L cohort, and 17.2 (15.5, 19.0), 12.4 (11.6, 13.5) and 3.4 (3.4, 3.4) months, respectively, in the carboplatin-paclitaxel subcohort.
Long-term outcomes were poor for both cohorts, particularly the carboplatin-paclitaxel subcohort, where patients did not receive radiotherapy and had predominantly metastatic disease. This reflects the unmet need for more durable treatment options to prevent relapse and prolong survival in this patient population. This real-world study will help contextualise outcomes from ongoing phase III clinical trials investigating 1L ICI treatments.
本研究在真实世界的数据中定义了一组英国患有原发性晚期或复发性(A/R)子宫内膜癌(EC)的患者回顾性队列,这些患者可能有资格参加评估免疫检查点抑制剂(ICIs)在一线(1L)治疗环境中的临床试验,并描述了该队列中的特征、治疗模式和结果。
这是一项回顾性、基于人群的研究。
使用来自英国国家癌症登记和分析服务的常规人群水平数据。纳入 2013 年 1 月 1 日至 2019 年 12 月 31 日期间诊断为 A/R EC 的患者(随访至 2021 年 8 月 23 日)。纳入符合 ICI 条件的患者,他们接受了任何 1L 治疗(定义为 A/R EC 的首次全身治疗,无论是否联合放疗),并符合 RUBY 试验的关键入选标准(NCT03981796;1L 队列)。确定了一个仅在 1L 接受卡铂紫杉醇治疗的亚组(卡铂紫杉醇亚组)。
报告人口统计学、特征和接受的治疗情况。使用 Kaplan-Meier 方法评估从 1L 化疗开始的总生存期(OS)、下一治疗时间(TTNT)和治疗停药时间(TTD)。
在确定的 13954 名患者中,2376 名符合 ICI 条件的患者被纳入 1L 队列(中位[范围]年龄:67.9[26.7-94.0]岁);902 名患者仅在 1L 接受卡铂紫杉醇治疗。队列之间的人口统计学和疾病特征通常相似。1L 队列中从 1L 化疗开始的中位(95%CI)OS、TTNT 和 TTD 分别为 27.2(24.7,30.2)、16.9(15.8,18.5)和 3.4(3.4,3.4)个月,卡铂紫杉醇亚组中分别为 17.2(15.5,19.0)、12.4(11.6,13.5)和 3.4(3.4,3.4)个月。
两个队列的长期结果都很差,特别是卡铂紫杉醇亚组,患者没有接受放疗,主要患有转移性疾病。这反映了在这一患者群体中,对更持久的治疗方案的需求尚未得到满足,以预防复发并延长生存时间。这项真实世界的研究将有助于从正在进行的评估 1L ICI 治疗的 III 期临床试验中了解结果。