Abstract
PurposeThe SAGIT® instrument, designed to assist clinicians to stage acromegaly, assess treatment response and adapt patient management, was well received by endocrinologists in a pilot study. We report an interim analysis of baseline data from the validation phase.MethodsThe SAGIT® validation study (ClinicalTrials.gov NCT02539927) is an international, non-interventional study. Data collection included: demographic/disease characteristics; medical/surgical histories; concomitant acromegaly treatments; investigators’ subjective evaluation of disease-control status (clinical global evaluation of disease control [CGE-DC]; controlled/not controlled/yet to be clarified) and clinical disease activity (active/not active); growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels; investigators’ therapeutic decision.ResultsOf 228 patients enrolled, investigators considered disease to be controlled in 110 (48.2%), not controlled in 105 (46.1%), and yet to be clarified in 13 (5.7%) according to CGE-DC. Thirty-three patients were treatment-naïve (not controlled, n = 31; yet to be clarified, n = 2). Investigators considered 48.2% patients in the controlled and 95.2% in the not-controlled groups to have clinically active disease. In the controlled group, 29.7% of patients did not exhibit hormonal control (GH ≤ 2.5 µg/L; normalized IGF-1) and 47.3% did not have rigorous hormonal control (GH < 1.0 µg/L; normalized IGF-1) by contemporary consensus. Current acromegaly treatment was continued with no change for 91.8% of patients in the controlled and 40.0% in the not-controlled groups.ConclusionsThese data highlight discrepancies between investigator-evaluated disease-control status, disease activity, hormonal control, and treatment decisions in acromegaly. Once validated, the SAGIT® instrument may assist clinicians in making active management decisions for patients with acromegaly.
Highlights
Is a multi-system disease characterized by overproduction of growth hormone (GH) and an accompanying increase in insulin-like growth factor-1 (IGF-1) levels, usually due to a GH-secreting pituitary tumor
We evaluate whether classifications of disease-control status align with disease activity, hormonal control (GH and IGF-1 levels obtained from routine hormone assays), and treatment decisions in acromegaly
A higher-than-expected proportion of enrolled patients did not have sufficient data to complete all SAGIT® items at baseline; as such, the protocol was that disease was CGE-DC controlled, 105 (46.1%) for whom disease was considered not controlled, and 13 (5.7%) in whom disease-control status was yet to be clarified
Summary
Is a multi-system disease characterized by overproduction of growth hormone (GH) and an accompanying increase in insulin-like growth factor-1 (IGF-1) levels, usually due to a GH-secreting pituitary tumor (predominantly macroadenomas). Diagnosis is based on the assessment of clinical manifestations, measurement of GH and IGF-1 levels, and pituitary magnetic resonance imaging (MRI) [2]. Treatment goals for management of acromegaly include reduction of tumor size and prevention of further tumor growth, and control of excessive GH secretion and IGF-1 levels [2, 3]. Difficulties in diagnosis (including discordant results from biochemical assays and discrepancies in signs and symptoms reported by the patient and physician) and a lack of formal disease staging using comprehensive clinical metrics, can impede effective management of acromegaly [4–7]. There is a need for a tool that captures biochemical, tumoral, and clinical information, to optimally diagnose, stage, and manage acromegaly
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