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HPV 阳性口咽癌同步顺铂或西妥昔单抗放化疗:De-ESCALaTE HPV 试验的医疗资源利用、成本和校正质量调整生存。

Concurrent cisplatin or cetuximab with radiotherapy for HPV-positive oropharyngeal cancer: Medical resource use, costs, and quality-adjusted survival from the De-ESCALaTE HPV trial.

机构信息

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.

出版信息

Eur J Cancer. 2020 Jan;124:178-185. doi: 10.1016/j.ejca.2019.10.025. Epub 2019 Nov 30.

Abstract

BACKGROUND

The De-ESCALaTE HPV trial confirmed the dominance of cisplatin over cetuximab for tumour control in patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC). Here, we present the analysis of health-related quality of life (HRQoL), resource use, and health care costs in the trial, as well as complete 2-year survival and recurrence.

MATERIALS AND METHODS

Resource use and HRQoL data were collected at intervals from the baseline to 24 months post treatment (PT). Health care costs were estimated using UK-based unit costs. Missing data were imputed. Differences in mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs) were compared using the Wilcoxon signed-rank test and linear regression, respectively. Mean resource usage and costs were compared through two-sample t-tests.

RESULTS

334 patients were randomised to cisplatin (n = 166) or cetuximab (n = 168). Two-year overall survival (97·5% vs 90·0%, HR: 3.268 [95% CI 1·451 to 7·359], p = 0·0251) and recurrence rates (6·4% vs 16·0%, HR: 2·67 [1·38 to 5·15]; p = 0·0024) favoured cisplatin. No significant differences in EQ-5D-5L utility scores were detected at any time point. At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin (95% CI: 0·186 to 0·029, p = 0·007) driven by the mortality difference. Health care costs were similar across all categories except the procurement cost and delivery of the systemic agent, with cetuximab significantly more expensive than cisplatin (£7779 [P < 0.001]). Consequently, total costs at 24 months PT averaged £13517 (SE: £345) per patient for cisplatin and £21064 (SE: £400) for cetuximab (mean difference £7547 [95% CI: £6512 to £8582]).

CONCLUSIONS

Cisplatin chemoradiotherapy provided more QALYs and was less costly than cetuximab bioradiotherapy, remaining standard of care for nonsurgical treatment of HPV-positive OPSCC.

摘要

背景

De-ESCALaTE HPV 试验证实,顺铂在肿瘤控制方面优于西妥昔单抗,适用于 HPV 阳性口咽鳞状细胞癌(OPSCC)患者。在此,我们报告了试验中与健康相关的生活质量(HRQoL)、资源使用和医疗保健成本分析,以及完整的 2 年生存率和复发率。

材料和方法

在治疗后(PT)的基线至 24 个月期间,每隔一段时间收集资源使用和 HRQoL 数据。使用基于英国的单位成本估算医疗保健成本。使用缺失数据插补法。使用 Wilcoxon 符号秩检验和线性回归分别比较平均 EQ-5D-5L 效用指数和调整后的累积质量调整生命年(QALYs)的差异。通过两样本 t 检验比较平均资源使用和成本。

结果

334 名患者被随机分配至顺铂组(n=166)或西妥昔单抗组(n=168)。2 年总生存率(97.5% vs 90.0%,HR:3.268 [95%CI 1.451 至 7.359],p=0.0251)和复发率(6.4% vs 16.0%,HR:2.67 [1.38 至 5.15];p=0.0024)均有利于顺铂。在任何时间点均未检测到 EQ-5D-5L 效用评分的显著差异。在 24 个月 PT 时,顺铂组平均 QALY 差值为 0.107(95%CI:0.186 至 0.029,p=0.007),这得益于死亡率的差异。除了系统药物的采购成本和配送成本外,所有类别的医疗保健成本均相似,西妥昔单抗的成本明显高于顺铂(£7779 [P<0.001])。因此,24 个月 PT 时,顺铂组每位患者的平均总成本为 £13517(SE:£345),西妥昔单抗组为 £21064(SE:£400)(平均差异为 £7547 [95%CI:£6512 至 £8582])。

结论

顺铂放化疗在提供 QALYs 方面优于西妥昔单抗生物放化疗,仍是 HPV 阳性 OPSCC 非手术治疗的标准护理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1bc/6947474/b2da0572d6b1/gr1.jpg

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