Isabelle Borget1, Julia Bonastre2, Bogdan Catargi2, Désirée Déandréis2, Slimane Zerdoud2, Daniela Rusu2, Stéphane Bardet2, Laurence Leenhardt2, Delphine Bastie2, Claire Schvartz2, Pierre Vera2, Olivier Morel2, Daniele Benisvy2, Claire Bournaud2, Francoise Bonichon2, Antony Kelly2, Marie-Elisabeth Toubert2, Sophie Leboulleux2, Florence Journeau2, Ellen Benhamou2, Martin Schlumberger2. 1. 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. isabelle.borget@gustaveroussy.fr. 2. 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.
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.
RCT Entities:
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 humanTSH [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.
Authors: Laurent Dercle; Désirée Deandreis; Marie Terroir; Sophie Leboulleux; Jean Lumbroso; Martin Schlumberger Journal: Eur J Nucl Med Mol Imaging Date: 2016-06 Impact factor: 9.236