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晚期非小细胞肺癌的医疗资源利用:随机 3 期 REVEL 研究的事后分析。

Healthcare resource utilization in advanced non-small-cell lung cancer: post hoc analysis of the randomized phase 3 REVEL study.

机构信息

David Geffen School of Medicine at UCLA/TRIO-US Network, Santa Monica, CA, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

Support Care Cancer. 2021 Jan;29(1):117-125. doi: 10.1007/s00520-020-05459-0. Epub 2020 Apr 21.

DOI:10.1007/s00520-020-05459-0
PMID:32318871
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7686169/
Abstract

PURPOSE

In REVEL, patients with advanced non-small-cell lung cancer (aNSCLC) and patients with increased tumor aggressiveness (rapid disease progression (RDP), platinum-refractory disease (PRD), and high symptom burden (HSB)) benefited from second-line treatment with ramucirumab plus docetaxel over placebo plus docetaxel. This post hoc analysis describes healthcare resource utilization (HCRU) associated with the treatment.

METHODS

aNSCLC patients who had progressed during or after first-line platinum-based chemotherapy were randomized to receive docetaxel and either ramucirumab or placebo until disease progression, unacceptable toxicity, withdrawal, or death. HCRU included hospitalizations, transfusions, and concomitant medications. Categorical variables (counts and percentages) were compared using Fisher's exact test. Continuous variables (mean, standard deviation (SD), median, minimum, and maximum) were compared using the Wilcoxon rank sum test.

RESULTS

Patient characteristics were largely similar between treatment arms. Within the intent-to-treat (ITT) population (n = 1253), the mean treatment duration was 19.7 and 16.9 weeks in the ramucirumab and control arms, respectively; 51.0% versus 54.9% of patients received subsequent anticancer therapy, respectively. Hospitalization rates were 41.9% versus 42.6% (p = 0.863), mean length of hospital stay was 14.5 days versus 11.3 days (p = 0.066), transfusion rates were 9.9% versus 12.3% (p = 0.206), and use of granulocyte colony-stimulating factors was 41.8% versus 36.6% (p = 0.063), respectively. No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497).

CONCLUSION

In REVEL, the addition of ramucirumab to docetaxel did not increase HCRU among patients with aggressive aNSCLC disease. These results may help inform economic evaluation of treatment for patients with aNSCLC.

摘要

目的

在 REVEL 研究中,晚期非小细胞肺癌(aNSCLC)患者和肿瘤侵袭性增加(快速疾病进展(RDP)、铂类耐药疾病(PRD)和高症状负担(HSB))患者从二线治疗中获益,接受雷莫芦单抗联合多西他赛治疗优于安慰剂联合多西他赛。本事后分析描述了与治疗相关的医疗资源利用(HCRU)。

方法

在一线含铂化疗期间或之后进展的 aNSCLC 患者被随机分配接受多西他赛和雷莫芦单抗或安慰剂,直至疾病进展、不可接受的毒性、退出或死亡。HCRU 包括住院、输血和伴随药物。使用 Fisher 确切检验比较分类变量(计数和百分比)。使用 Wilcoxon 秩和检验比较连续变量(均值、标准差(SD)、中位数、最小值和最大值)。

结果

治疗组之间患者特征基本相似。在意向治疗(ITT)人群(n=1253)中,雷莫芦单抗组和对照组的中位治疗持续时间分别为 19.7 周和 16.9 周;分别有 51.0%和 54.9%的患者接受了后续抗癌治疗。住院率分别为 41.9%和 42.6%(p=0.863),平均住院天数分别为 14.5 天和 11.3 天(p=0.066),输血率分别为 9.9%和 12.3%(p=0.206),粒细胞集落刺激因子使用率分别为 41.8%和 36.6%(p=0.063)。在 ITT 人群和包括 RDP(n=209)、PRD(n=360)和 HSB(n=497)在内的侵袭性疾病亚组中,治疗组之间的 HCRU 无显著差异。

结论

在 REVEL 研究中,雷莫芦单抗联合多西他赛并未增加侵袭性 aNSCLC 疾病患者的 HCRU。这些结果可能有助于为 NSCLC 患者的治疗提供经济评估信息。

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