Description of the SAGhE cohort

A large european study of mortality and cancer incidence risks after childhood treatment with recombinant growth hormone

Anthony J. Swerdlow, Rosie Cooke, Kerstin Albertsson-Wikland, Birgit Borgström, Gary Butler, Stefano Cianfarani, Peter Clayton, Joël Coste, Annalisa Deodati, Emmanuel Ecosse, Ruth Gausche, Claudio Giacomozzi, Wieland Kiess, Anita C S Hokken-Koelega, Claudia E. Kuehni, Fabienne Landier, Marc Maes, Primus E. Mullis, Roland Pfaffle, Lars Sävendahl & 5 others Grit Sommer, Muriel Thomas, Sally Tollerfield, Gladys R J Zandwijken, Jean Claude Carel

Research output: Contribution to journalArticle

19 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)172-183
Number of pages12
JournalHormone Research in Paediatrics
Volume84
Issue number3
DOIs
Publication statusPublished - Sep 22 2015

Fingerprint

Growth Hormone
Safety
Mortality
Incidence
Neoplasms
Human Growth Hormone
Therapeutics
Cohort Studies
Turner Syndrome
Industry
Growth
Pharmaceutical Preparations
Population

Keywords

  • Cancer
  • Cohort
  • Europe
  • Growth hormone
  • Mortality

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Description of the SAGhE cohort : A large european study of mortality and cancer incidence risks after childhood treatment with recombinant growth hormone. / Swerdlow, Anthony J.; Cooke, Rosie; Albertsson-Wikland, Kerstin; Borgström, Birgit; Butler, Gary; Cianfarani, Stefano; Clayton, Peter; Coste, Joël; Deodati, Annalisa; Ecosse, Emmanuel; Gausche, Ruth; Giacomozzi, Claudio; Kiess, Wieland; Hokken-Koelega, Anita C S; Kuehni, Claudia E.; Landier, Fabienne; Maes, Marc; Mullis, Primus E.; Pfaffle, Roland; Sävendahl, Lars; Sommer, Grit; Thomas, Muriel; Tollerfield, Sally; Zandwijken, Gladys R J; Carel, Jean Claude.

In: Hormone Research in Paediatrics, Vol. 84, No. 3, 22.09.2015, p. 172-183.

Research output: Contribution to journalArticle

Swerdlow, AJ, Cooke, R, Albertsson-Wikland, K, Borgström, B, Butler, G, Cianfarani, S, Clayton, P, Coste, J, Deodati, A, Ecosse, E, Gausche, R, Giacomozzi, C, Kiess, W, Hokken-Koelega, ACS, Kuehni, CE, Landier, F, Maes, M, Mullis, PE, Pfaffle, R, Sävendahl, L, Sommer, G, Thomas, M, Tollerfield, S, Zandwijken, GRJ & Carel, JC 2015, 'Description of the SAGhE cohort: A large european study of mortality and cancer incidence risks after childhood treatment with recombinant growth hormone', Hormone Research in Paediatrics, vol. 84, no. 3, pp. 172-183. https://doi.org/10.1159/000435856
Swerdlow, Anthony J. ; Cooke, Rosie ; Albertsson-Wikland, Kerstin ; Borgström, Birgit ; Butler, Gary ; Cianfarani, Stefano ; Clayton, Peter ; Coste, Joël ; Deodati, Annalisa ; Ecosse, Emmanuel ; Gausche, Ruth ; Giacomozzi, Claudio ; Kiess, Wieland ; Hokken-Koelega, Anita C S ; Kuehni, Claudia E. ; Landier, Fabienne ; Maes, Marc ; Mullis, Primus E. ; Pfaffle, Roland ; Sävendahl, Lars ; Sommer, Grit ; Thomas, Muriel ; Tollerfield, Sally ; Zandwijken, Gladys R J ; Carel, Jean Claude. / Description of the SAGhE cohort : A large european study of mortality and cancer incidence risks after childhood treatment with recombinant growth hormone. In: Hormone Research in Paediatrics. 2015 ; Vol. 84, No. 3. pp. 172-183.
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AU - Swerdlow, Anthony J.

AU - Cooke, Rosie

AU - Albertsson-Wikland, Kerstin

AU - Borgström, Birgit

AU - Butler, Gary

AU - Cianfarani, Stefano

AU - Clayton, Peter

AU - Coste, Joël

AU - Deodati, Annalisa

AU - Ecosse, Emmanuel

AU - Gausche, Ruth

AU - Giacomozzi, Claudio

AU - Kiess, Wieland

AU - Hokken-Koelega, Anita C S

AU - Kuehni, Claudia E.

AU - Landier, Fabienne

AU - Maes, Marc

AU - Mullis, Primus E.

AU - Pfaffle, Roland

AU - Sävendahl, Lars

AU - Sommer, Grit

AU - Thomas, Muriel

AU - Tollerfield, Sally

AU - Zandwijken, Gladys R J

AU - Carel, Jean Claude

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N2 - 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.

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KW - Cohort

KW - Europe

KW - Growth hormone

KW - Mortality

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