ECE2020 Audio ePoster Presentations Pituitary and Neuroendocrinology (217 abstracts)
Patients receiving a range of doses of prior injectable somatostatin receptor ligands respond to oral octreotide in the treatment of acromegaly: Results from the phase 3 optimal study
Lisa Nachtigall 1 , Susan Samson 2 , Maria Fleseriu 3 , Marek Bolanowski 4 , Mark E Molitch 5 , William Ludlam 6 , Gary Patou 6 , Asi Haviv 6 , Patrick Manning 7 , Nienke Biermasz 8 , Andrea Giustina 9 , Christian J Strasburger 10 , Shlomo Melmed 11 & Laurence Kennedy 12
1MGH Neuroendocrine and Pituitary Center, Portland, United States; 2Baylor College of Medicine, Portland, United States; 3Oregon Health & Science University, Portland, United States; 4Department of Endocrinology, Diabetes and Isotope Therapy, Wroclaw Medical University, Evanston, United States; 5Northwestern University, Evanston, United States; 6Chiasma, Italy; 7Dunedin Hospital, Italy; 8LUMC - Endocrinology and Metabolisme, Italy; 9University of Brescia, Italy; 10Charité Campus Mitte, Italy; 11Cedars Sinai Medical Center, Italy; 12Cleveland Clinic Foundation, Italy
Background: Injectable somatostatin receptor ligands (SRLs) are the most widely used therapy to control acromegaly. Oral octreotide capsules (OOC) have been formulated as a potential therapy for this disorder and the efficacy and safety was evaluated in the CHIASMA OPTIMAL prospective phase 3 study in patients with acromegaly who were controlled on injectable SRL treatment of varying doses (Samson et al. ENDO 2020).
Methods: Patients with confirmed acromegaly who had been receiving a stable dose of injectable SRL (≥ 3 months), were randomized to receive OOC (40 mg/day) or placebo for 36 weeks. Patients were dose titrated to 60 or 80 mg OOC or equivalent placebo through week 24 at the investigator’s discretion based on increased IGF-I levels or worsening acromegaly signs/symptoms. The primary efficacy endpoint was the proportion of patients who maintained their biochemical response at the end of 36 weeks, defined as average IGF-I ≤ 1 xULN between Weeks 34 and 36. An analysis evaluated maintenance of response based on prior dose of injectable SRL. Prior doses of injectable SRL were categorized based on the following classifications: octreotide 10 mg every 4 weeks or lanreotide 60 mg every 4 weeks or 120 mg every 8 weeks were stratified as low; octreotide 20 mg every 4 weeks or lanreotide 90 mg every 4 weeks or 120 mg every 6 weeks were stratified as medium; octreotide 30 mg or 40 mg or lanreotide 120 mg every 4 weeks were stratified as high. Randomization was stratified based on low dose vs med/high dose and efficacy results compared for these strata. The response rates reported for the primary endpoint are adjusted for stratification differences as prespecified in the statistical analysis plan.
Results: Six patients (21.4%) in the OOC group had received prior treatment with low doses of injectable SRLs while 22 (78.6%) had received prior treatment with medium-high doses of injectable SRLs. Maintenance of response was observed in 16 patients receiving OOC. This included 66.7% of patients (n = 4) previously receiving low doses of injected SRLs and 54.5% of patients (n = 12) on medium-high injected doses. The treatment effect was consistent irrespective of prior dose of injectable SRL (odds ratio: 5.4 in low dose and 5.9 in medium-high dose).
Conclusion: The CHIASMA OPTIMAL study recruited a population receiving predominantly medium-high doses of injectable SRLs and demonstrated maintenance of response in 58% of patients. OOC treatment effect was consistent irrespective of prior dose of injectable SRL.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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