Background: Concern remains regarding the potential influence of growth hormone (GH) treatment on neoplasia because of the general growth-inducing effect of GH and associations between high serum IGF1 concentrations and certain cancers in adulthood. Many studies that evaluated risk for primary cancer in GH-treated patients without previous malignancy found no increased rates of primary neoplasia. A higher risk for colorectal cancer was observed in a single-country cohort treated with cadaveric GH.
Objective and hypotheses: To assess primary cancer occurrence in the prospective, multinational GeNeSIS observational study of paediatric GH use and compare observed cases with rates from general population cancer registries (USA: SEER; other countries: GLOBOCAN).
Method: Study data and serious adverse event reports for patients with ≧1 follow-up visit were examined to identify and exclude those without previous history of malignancy and to ascertain incident cases of primary cancer. 19054 GH-treated patients without previous cancer were identified (40% female; 63% with GH deficiency, 13% idiopathic short stature, 9% Turner syndrome, 6% born small for gestational age, and 9% other diagnoses; mean±SD baseline age 9.5±4.0 years; mean follow-up time 3.4±2.5 years).
Results: Thirteen incident primary cancers were ascertained, with mean±SD age at cancer onset of 13.5±2.7 years. The standardized incidence ratio (SIR) (95% CI) for primary cancers was 1.02 (0.541.75) for all countries combined; no individual country had a significantly elevated SIR. Ten of the affected patients (four lymphoma cases, three germ cell tumours, Ewing sarcoma, osteosarcoma, and skin cancer) had no neoplastic history. Three patients had neoplastic history/predisposition (rectal adenocarcinoma in a patient with neurofibromatosis and Gardner syndrome, pancreatic neuroendocrine tumour in a patient with neurofibromatosis, and malignant schwannoma in a patient with previous pilocytic astrocytoma).
Conclusion: Risk for all sites primary cancers in GH-treated patients without previous cancer was no higher in GeNeSIS than in general population cancer registries.
Conflict of interest: The author is an employee and stockholder of Eli Lilly and Company.
Funding: Sponsored by Eli Lilly and Company.
01 Oct 2015 - 03 Oct 2015