Objective: To assess the incidence of cancer in patients treated with growth hormone (GH) in KIGS - the Pfizer International Growth Database-without cancer or any other condition in medical history known to increase the risk of cancer.
Study design: Data were analyzed from patients with growth disorders enrolled in an observational survey KIGS who had no known increased risk of developing cancer before starting recombinant human GH treatment. The incidence of cancer in this patient cohort (overall, site-specific, and according to etiology of growth disorder) was compared with the incidence in the general population by using the standardized incidence ratio (ie, relating the observed to expected number of cases with stratification for age, sex, and country).
Results: A total of 32 new malignant neoplasms were reported in 58 603 patients, versus the 25.3 expected (incidence, 16.4 per 100 000 patient-years; standardized incidence ratio, 1.26; 95% confidence interval, 0.86-1.78). No category of growth disorder showed a statistically significant difference in observed compared with the expected number of cases.
Conclusion: There is no evidence in this series that GH treatment in young patients with growth disorders results in an increased risk of developing cancer relative to that expected in the normal population. However, surveillance for an extended time should continue to allow further assessment.