Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone
Anthony Swerdlow
(1)
,
Rosie Cooke
(1)
,
Kerstin Albertsson-Wikland
(2)
,
Birgit Borgström
(3)
,
Gary Butler
(4, 5)
,
Stefano Cianfarani
(6, 3)
,
Peter Clayton
(7, 8)
,
Joël Coste
(9, 10)
,
Annalisa Deodati
(6)
,
Emmanuel Ecosse
(9, 10)
,
Ruth Gausche
(11)
,
Claudio Giacomozzi
(6)
,
Wieland Kiess
(11)
,
Anita Hokken-Koelega
(12, 13)
,
Claudia Kuehni
(14)
,
Fabienne Landier
(15, 16, 17, 18)
,
Marc Maes
(19)
,
Primus-E Mullis
(20)
,
Roland Pfaffle
(11)
,
Lars Sävendahl
(3)
,
Grit Sommer
(14)
,
Muriel Thomas
(21)
,
Sally Tollerfield
(4)
,
Gladys Zandwijken
(12)
,
Jean-Claude Carel
(15, 16, 17, 18)
1
Institute of Cancer Research - ICR [London, U.K.]
2 Sahlgrenska Academy at University of Gothenburg [Göteborg]
3 Karolinska Institutet [Stockholm]
4 Institute of Child Health [London]
5 UCLH - University College London Hospitals
6 IRCCS Ospedale Pediatrico Bambino Gesù = Bambino Gesù Children’s Hospital
7 Royal Manchester Children's Hospital
8 University of Manchester [Manchester]
9 Unité d’Epidémiologie et de Biostatistiques [APHP Cochin-Broca-Hôtel Dieu]
10 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
11 Leipzig University / Universität Leipzig
12 Erasmus MC - Erasmus University Medical Center [Rotterdam]
13 Sophia Children's Hospital
14 ISPM - Institute of Social and Preventive Medicine [Bern]
15 Centre de Référence des Maladies Endocriniennes Rares de la Croissance [APHP Robert Debré]
16 Service d'endocrinologie diabétologie pédiatrique [CHU Debré]
17 UPD7 - Université Paris Diderot - Paris 7
18 Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Hopital Robert Debre
19 Cliniques universitaires St Luc [Bruxelles]
20 Inselspital Bern
21 BSGPE - Belgian Study Group for Pediatric Endocrinology
2 Sahlgrenska Academy at University of Gothenburg [Göteborg]
3 Karolinska Institutet [Stockholm]
4 Institute of Child Health [London]
5 UCLH - University College London Hospitals
6 IRCCS Ospedale Pediatrico Bambino Gesù = Bambino Gesù Children’s Hospital
7 Royal Manchester Children's Hospital
8 University of Manchester [Manchester]
9 Unité d’Epidémiologie et de Biostatistiques [APHP Cochin-Broca-Hôtel Dieu]
10 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
11 Leipzig University / Universität Leipzig
12 Erasmus MC - Erasmus University Medical Center [Rotterdam]
13 Sophia Children's Hospital
14 ISPM - Institute of Social and Preventive Medicine [Bern]
15 Centre de Référence des Maladies Endocriniennes Rares de la Croissance [APHP Robert Debré]
16 Service d'endocrinologie diabétologie pédiatrique [CHU Debré]
17 UPD7 - Université Paris Diderot - Paris 7
18 Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Hopital Robert Debre
19 Cliniques universitaires St Luc [Bruxelles]
20 Inselspital Bern
21 BSGPE - Belgian Study Group for Pediatric Endocrinology
Gary Butler
- Function : Author
Peter Clayton
- Function : Author
- PersonId : 889727
Fabienne Landier
- Function : Author
Muriel Thomas
- Function : Author
- PersonId : 749364
- IdHAL : muriel-thomas
- ORCID : 0000-0002-7608-3274
- IdRef : 166963143
Jean-Claude Carel
- Function : Author
Abstract
BACKGROUND:
The long-term safety of growth hormone treatment is uncertain. Raised risks of death and certain cancers have been reported inconsistently, based on limited data or short-term follow-up by pharmaceutical companies.
PATIENTS AND METHODS:
The SAGhE (Safety and Appropriateness of Growth Hormone Treatments in Europe) study assembled cohorts of patients treated in childhood with recombinant human growth hormone (r-hGH) in 8 European countries since the first use of this treatment in 1984 and followed them for cause-specific mortality and cancer incidence. Expected rates were obtained from national and local general population data. The cohort consisted of 24,232 patients, most commonly treated for isolated growth failure (53%), Turner syndrome (13%) and growth hormone deficiency linked to neoplasia (12%). This paper describes in detail the study design, methods and data collection and discusses the strengths, biases and weaknesses consequent on this.
CONCLUSION:
The SAGhE cohort is the largest and longest follow-up cohort study of growth hormone-treated patients with follow-up and analysis independent of industry. It forms a major resource for investigating cancer and mortality risks in r-hGH patients. The interpretation of SAGhE results, however, will need to take account of the methods of cohort assembly and follow-up in each country.