Background: Growth Hormone (GH) promotes body growth. If GH production is impaired, it can be substituted with daily injections. Growth hormone deficiency (GHD) is the most common endocrine late effect of childhood cancer treatment, especially after brain tumours and/or cranial irradiation. However, well-conducted long-term studies on the safety of GH replacement therapy are lacking, and several experimental studies raised concerns about cancer risk and long-term mortality. These questions are investigated in the European FP-7 project “Safety and Appropriateness of Growth hormone treatments in Europe” (SAGhE).

Objectives: The project investigates long-term efficacy (final height), health related quality of life (HRQoL) and long-term safety of GH-treatment in childhood, in particular the risk of cancer and/or mortality.

Methods: Cohort study based on the population of patients who were treated with GH during childhood in Switzerland since 1985. Eligible patients were identified from paediatric endocrinology centres in Switzerland; the SCCR and the Swiss Paediatric Renal Registry, and databases from pharmaceutical companies. Relevant data were extracted from hospital records. Quality of life was assessed by a questionnaire. Incident cancers were assessed via linkage with the SCCR and cantonal cancer registries. Date and place of death were obtained via municipal population registers, cause of death from the mortality statistics. Risk of cancer and mortality in the cohort were compared to the risk in the general population by calculating standardized incidence ratios and standardized mortality ratios.

Rationale and significance: The project describes the use of GH in Switzerland and analyses long-term safety in the context of a high-quality international collaborative study. Results will likely influence future recommendations for treatment with GH in children.

Current status of project: We identified 1884 patients treated with GH during childhood. Patients older than 18 years were included in the SAGhE study (N=754). We assessed health related quality of life for patients over 18 years via a postal questionnaire. A total of 687 patients were eligible and 415 (60%) replied. All data have been sent to work package leaders and publications are expected in 2015.

Study team: Kuehni CE, Sommer G, Kuonen R. Institute of Social and Preventive Medicine, University of Bern; Mullis PE. University Children’s Hospital, Inselspital Bern.

Funding: European Union FP7 (Grant No HEALTH-F2-2009-223497), Swiss Cancer League (Grant No KLS-02586-02-2010 and KLS-2948-02-2012).

Contact: Claudia Kuehni (, Grit Sommer (



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