4.7 Article

Cancer Risks in Patients Treated With Growth Hormone in Childhood: The SAGhE European Cohort Study

Journal

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Volume 102, Issue 5, Pages 1661-1672

Publisher

ENDOCRINE SOC
DOI: 10.1210/jc.2016-2046

Keywords

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Funding

  1. European Union [HEALTH-F2-2009-223497]
  2. Belgian Study Group for Paediatric Endocrinology (BSGPE)
  3. Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS, the French drug safety agency)
  4. Direction Generale de la Sante (DGS, French Ministry of Health)
  5. Institut National du Cancer (INCa)
  6. EC European Commission [FP7-HEALTH-2007-3. 1-5]
  7. Swedish Research Council, Regional University Hospital Grants (ALF)
  8. Swedish Cancer Society
  9. Swedish Childhood Cancer Foundation
  10. Swiss Cancer League [KLS-02586- 02-2010, KLS-2948-02-2012]
  11. Pfizer AG
  12. Novo Nordisk Pharma AG
  13. Sandoz Pharmaceuticals AG
  14. UK Child Growth Foundation

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Context: Growth hormone (GH) is prescribed for an increasing range of indications, but there has been concern that it might raise cancer risk. Published data are limited. Objective: To examine cancer risks in relation to GH treatment. Design: Cohort study. Setting: Population-based. Patients: Cohort of 23,984 patients treated with recombinant human GH (r-hGH) in eight European countries since this treatment was first used in 1984. Cancer expectations from country-specific national population statistics. Main Outcome Measures: Cancer incidence and cancer mortality. Results: Incidence and mortality risks in the cohort were raised for several cancer sites, largely consequent on second primary malignancies in patients given r-hGH after cancer treatment. There was no clear raised risk in patients with growth failure without other major disease. Only for bone and bladder cancers was incidence significantly raised in GH-treated patients without previous cancer. Cancer risk was unrelated to duration or cumulative dose of r-hGH treatment, but for patients treated after previous cancer, cancer mortality risk increased significantly with increasing daily r-hGH dose (P trend < 0.001). Hodgkin lymphoma (HL) incidence increased significantly with longer follow-up (P trend = 0.001 for patients overall and 0.002 for patients without previous cancer). Conclusions: Our results do not generally support a carcinogenic effect of r-hGH, but the unexplained trend in cancer mortality risk in relation to GH dose in patients with previous cancer, and the indication of possible effects on bone cancer, bladder cancer, and HL risks, need further investigation.

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