甲状腺癌患者放射性碘消融策略的生活质量和成本效益评估：来自随机 III 期 ESTIMABL 试验的结果。

Quality of Life and Cost-Effectiveness Assessment of Radioiodine Ablation Strategies in Patients With Thyroid Cancer: Results From the Randomized Phase III ESTIMABL Trial.

机构信息

Isabelle Borget, Julia Bonastre, Désirée Déandréis, Sophie Leboulleux, Florence Journeau, Ellen Benhamou, and Martin Schlumberger, Gustave Roussy, Villejuif; Isabelle Borget, Julia Bonastre, and Ellen Benhamou, Center for Research in Epidemiology and Population Health, L'Institut National de la Santé et de la Recherche Médicale 1018; Isabelle Borget and Martin Schlumberger, University Paris-Sud; Laurence Leenhardt, Hôpital Pitié-Salpétrière; Marie-Elisabeth Toubert, Hôpital Saint-Louis, Paris; Bogdan Catargi, Centre Hospitalier Universitaire (CHU) Bordeaux; Francoise Bonichon, Institut Bergonié, Bordeaux; Slimane Zerdoud, Centre Claudius Regaud; Delphine Bastie, CHU Toulouse, Toulouse; Daniela Rusu, Centre René Gauducheau, Nantes; Stéphane Bardet, Centre François Baclesse, Caen; Claire Schvartz, Institut Jean Godinot, Reims; Pierre Vera, Centre Becquerel, Rouen; Olivier Morel, Institut de Cancérologie de l'Ouest, Paul Papin, Angers; Daniele Benisvy, Centre Lacassagne, Nice; Claire Bournaud, CHU Lyon, Lyon; and Antony Kelly, Centre Jean Perrin, Clermont-Ferrand, France.

出版信息

J Clin Oncol. 2015 Sep 10;33(26):2885-92. doi: 10.1200/JCO.2015.61.6722. Epub 2015 Aug 3.

DOI:10.1200/JCO.2015.61.6722

PMID:26240230

Abstract

PURPOSE

In the ESTIMABL phase III trial, the thyroid ablation rate was equivalent for the two thyroid-stimulating hormone (TSH) stimulation methods (thyroid hormone withdrawal [THW] and recombinant human TSH [rhTSH]) and the two iodine-131 ((131)I) activities (1.1 or 3.7 GBq). The objectives of this article were to present health-related quality-of-life (HRQoL) results and a cost-effectiveness evaluation performed alongside this trial.

PATIENTS AND METHODS

HRQoL and utility were longitudinally assessed, from random assignment to the follow-up visit at 8 ± 2 months for the 752 patients with thyroid cancer, using the Short Form-36 and the EuroQoL-5D questionnaires, respectively. A cost-effectiveness analysis was performed from the societal perspective in the French context. Resource use (hospitalization for (131)I administration, rhTSH, sick leaves, and transportation) was collected prospectively. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for both TSH stimulation methods and (131)I activities. Sensitivity analyses of the costs of rhTSH were performed.

RESULTS

At (131)I administration, THW caused a clinically significant deterioration of HRQoL, whereas HRQoL remained stable with rhTSH. This deterioration was transient with no difference 3 months later. rhTSH was more effective than THW in terms of quality-adjusted life-years (QALYs; +0.013 QALY/patient) but more expensive (+€474/patient). The probability that rhTSH would be cost effective at a €50,000/QALY threshold was 47% in France. The use of 1.1 GBq of (131)I instead of 3.7 GBq reduced per-patient costs by €955 (US$1,018) but with slightly decreased efficacy (-0.007 QALY/patient).

CONCLUSION

rhTSH avoids the transient THW-induced deterioration of HRQoL but is unlikely to be cost effective at its current price.

摘要

目的

在 ESTIMABL Ⅲ期临床试验中，两种促甲状腺激素（TSH）刺激方法（甲状腺激素撤退[THW]和重组人 TSH[rhTSH]）和两种碘-131（(131)I）活度（1.1 或 3.7GBq）的甲状腺消融率相当。本文的目的是介绍与该试验同时进行的健康相关生活质量（HRQoL）结果和成本效益评估。

患者和方法

从随机分组到 752 例甲状腺癌患者 8±2 个月的随访，使用简短形式-36 和 EuroQoL-5D 问卷分别进行了 HRQoL 和效用的纵向评估。从法国社会的角度进行了成本效益分析。前瞻性收集资源利用（（131)I 给药的住院治疗、rhTSH、病假和交通）。我们使用净货币收益方法，并为两种 TSH 刺激方法和(131)I 活性计算了成本效益接受曲线。对 rhTSH 成本进行了敏感性分析。

结果

在（131)I 给药时，THW 导致 HRQoL 出现临床显著恶化，而 rhTSH 则保持稳定。这种恶化是短暂的，3 个月后没有差异。rhTSH 在质量调整生命年（QALYs；每例患者+0.013QALY）方面比 THW 更有效，但更昂贵（每位患者+474 欧元）。rhTSH 在法国以 50,000 欧元/QALY 为阈值具有成本效益的概率为 47%。使用 1.1GBq 的(131)I 代替 3.7GBq 可使每位患者的成本降低 955 欧元（1018 美元），但疗效略有降低（每例患者-0.007QALY）。