背景:在关键的III期回顾试验中,氟尿苷/替吡草定(FTD/TPI)改善无进展生存期和总生存期(PFS,OS)治疗前转移性结直肠癌(mCRC)患者。随后,TALLISUR试验提供了德国患者队列的授权后疗效和安全性数据以及患者报告的生活质量(QoL)结局.本分析报告了疗效的最终数据,安全性和QoL,并研究基线特征和相关预后亚组对结局的影响。
方法:在此前瞻性中,多中心,全德国,第四阶段研究,接受mCRC治疗前的患者可以选择接受FTD/TPI或最佳支持治疗(BSC).要评估主要终点,QoL,采用EORTCQLQ-C30问卷。次要终点包括通过EQ-5D-5L问卷评估的QoL,操作系统,PFS和安全。此外,根据对RECOURSE试验的事后分析定义了3个亚组:最佳,预后特征好和差(BPC,GPC,PPC)。纳入时转移部位<3个和/或从诊断到纳入≥18个月的患者被认为患有GPC。纳入时无肝转移的GPC患者被认为患有BPC。所有剩余患者被认为患有PPC。
结果:在195名患者中,186决定接收FTD/TPI,9决定接收BSC。BSC组中患者数量少,无法进行有统计学意义的分析。FTD/TPI治疗与QoL维持相关。对于所有患者来说,中位OS为6.9个月(95%CI6.1-8.3),定义的亚组(BPCn=20,GPCn=65,PPCn=121)为12.2、7.9和6.8个月(95%CI6.0-18.2,6.2-13.3,5.4-8.1).最常见的TEAE是中性粒细胞减少症(29.6%),贫血(24.7%)和恶心(23.7%)。发热性中性粒细胞减少发生率为1.1%。
结论:用FTD/TPI治疗患有治疗前mCRC的患者不仅与延长生存期和延迟进展相关,而且还保持了QoL。独立于其他基线特征,如ECOG表现状态和年龄,低转移负荷和惰性疾病是预后良好的相关因素.
背景:EudraCT-编号2017-000292-83,首次注册19/06/2017。
BACKGROUND: In the pivotal phase III RECOURSE trial, trifluridine/tipiracil (FTD/TPI) improved progression-free and overall survival (PFS, OS) of patients with pre-treated metastatic colorectal cancer (mCRC). Subsequently, the TALLISUR trial provided post-authorisation efficacy and safety data and patient-reported outcomes on quality of life (QoL) in a German patient cohort. The present analysis reports the final data on efficacy, safety and QoL and investigates the impact of baseline characteristics and associated prognostic subgroups on outcome.
METHODS: In this prospective, multi-centre, Germany-wide, phase IV study, patients with pre-treated mCRC were given the choice to receive either FTD/TPI or best supportive care (BSC). To assess the primary endpoint, QoL, EORTC QLQ-C30 questionnaires were employed. Secondary endpoints included QoL assessed through EQ-5D-5L questionnaires, OS, PFS and safety. Additionally, 3 subgroups were defined according to a post-hoc analysis of the RECOURSE trial: best, good and poor prognostic characteristics (BPC, GPC, PPC). Patients with < 3 metastatic sites at inclusion and/or ≥ 18 months from diagnosis to inclusion were considered to have GPC. GPC patients without liver metastasis at inclusion were considered to have BPC. All remaining patients were considered to have PPC.
RESULTS: Of 195 patients, 186 decided to receive FTD/TPI and 9 to receive BSC. The low number of patients in the BSC-arm did not allow statistically meaningful analyses. Treatment with FTD/TPI was associated with maintained QoL. For all patients, median OS was 6.9 months (95% CI 6.1 - 8.3) and for the defined subgroups (BPC n = 20 vs GPC n = 65 vs PPC n = 121) 12.2, 7.9 and 6.8 months (95% CI 6.0 - 18.2, 6.2 - 13.3, 5.4 - 8.1). The most frequent TEAEs were neutropenia (29.6%), anaemia (24.7%) and nausea (23.7%). Febrile neutropenia occurred in 1.1%.
CONCLUSIONS: Treatment of patients suffering from pre-treated mCRC with FTD/TPI was associated not only with prolonged survival and delayed progression, but also with maintained QoL. Independent of other baseline characteristics such as ECOG performance status and age, low metastatic burden and indolent disease were factors associated with favourable outcome.
BACKGROUND: EudraCT-Number 2017-000292-83, first registration 19/06/2017.