多中心真实世界研究：纳武利尤单抗治疗非小细胞肺癌患者的有效性和早期停药预测因素。
Multicenter Real-World Study on Effectiveness and Early Discontinuation Predictors in Patients With Non-small Cell Lung Cancer Receiving Nivolumab.
机构信息
Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.
出版信息
Oncologist. 2022 Jun 8;27(6):e484-e493. doi: 10.1093/oncolo/oyac051.
BACKGROUND
Real-world (RW) evidence on nivolumab in pretreated patients with non-small cell lung cancer (NSCLC) by matching data from administrative health flows (AHFs) and clinical records (CRs) may close the gap between pivotal trials and clinical practice.
METHODS
This multicenter RW study aims at investigating median time to treatment discontinuation (mTTD), overall survival (mOS) of nivolumab in pretreated patients with NSCLC both from AHF and CR; clinical-pathological features predictive of early treatment discontinuation (etd), budget impact (BI), and cost-effectiveness analysis were investigated; mOS in patients receiving nivolumab and docetaxel was assessed.
RESULTS
Overall, 237 patients with NSCLC treated with nivolumab were identified from AHFs; mTTD and mOS were 4.2 and 9.8 months, respectively; 141 (59%) received at least 6 treatment cycles, 96 (41%) received < 6 (etd). Median overall survival in patients with and without etd were 3.3 and 19.6 months, respectively (P < .0001). Higher number, longer duration, and higher cost of hospitalizations were observed in etd cases. Clinical records were available for 162 patients treated with nivolumab (cohort 1) and 83 with docetaxel (cohort 2). Median time to treatment discontinuation was 4.8 and 2.6 months, respectively (P < .0001); risk of death was significantly higher in cohort 2 or cohort 1 with etd compared with cohort 1 without etd (P < .0001). Predictors of etd were body mass index <25, Eastern Cooperative Oncology Group performance status >1, neutrophile-to-lymphocyte ratio >2.91, and concomitant treatment with antibiotics and glucocorticoids. The incremental cost-effectiveness ratio of nivolumab was 3323.64 euros ($3757.37) in all patients and 2805.75 euros ($3171.47) for patients without etd. Finally, the BI gap (real-theoretical) was 857 188 euros ($969 050.18).
CONCLUSION
We defined predictors and prognostic-economic impact of nivolumab in etd patients.
背景
通过匹配行政健康流量（AHF）和临床记录（CR）数据，真实世界（RW）研究中的纳武利尤单抗治疗预处理非小细胞肺癌（NSCLC）患者的数据可能会缩小关键试验和临床实践之间的差距。
方法
这项多中心 RW 研究旨在研究 NSCLC 预处理患者的纳武利尤单抗的中位治疗停止时间（mTTD）和总生存期（mOS），这两个数据分别来自 AHF 和 CR；还研究了临床病理特征对早期治疗停止（etd）、预算影响（BI）和成本效益分析的预测作用；并评估了接受纳武利尤单抗和多西他赛治疗的患者的 mOS。
结果
共从 AHF 中确定了 237 例 NSCLC 接受纳武利尤单抗治疗的患者；mTTD 和 mOS 分别为 4.2 个月和 9.8 个月；141 例（59%）患者至少接受了 6 个治疗周期，96 例（41%）患者接受了 < 6 个周期（etd）。有和无 etd 的患者的中位总生存期分别为 3.3 个月和 19.6 个月（P <.0001）。etd 病例的住院次数、住院时间和住院费用均较高。纳武利尤单抗治疗的患者中有 162 例（队列 1）和 83 例（队列 2）可提供临床记录。mTTD 分别为 4.8 个月和 2.6 个月（P <.0001）；与队列 1 无 etd 相比，队列 2 或队列 1 中有 etd 的患者死亡风险显著更高（P <.0001）。etd 的预测因素是 BMI<25、ECOG 表现状态 >1、中性粒细胞与淋巴细胞比值>2.91、以及同时使用抗生素和糖皮质激素。所有患者的纳武利尤单抗增量成本效益比为 3323.64 欧元（3757.37 美元），无 etd 的患者为 2805.75 欧元（3171.47 美元）。最后，BI 差距（实际-理论）为 857 188 欧元（969 050.18 美元）。
结论
我们确定了预测因素和影响 etd 患者纳武利尤单抗预后经济性的因素。
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