Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Eur J Cancer. 2020 Jan;124:178-185. doi: 10.1016/j.ejca.2019.10.025. Epub 2019 Nov 30.
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.
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.
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]).
Cisplatin chemoradiotherapy provided more QALYs and was less costly than cetuximab bioradiotherapy, remaining standard of care for nonsurgical treatment of HPV-positive OPSCC.
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。
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。
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])。
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。