Session: OR27-Pituitary: Acromegaly and Prolactinoma
Room 135 (Moscone Center)
Aims: This is the first study focusing on tumor volume during first-line therapy with high-dose lanreotide Autogel over 1-yr in a large homogenous treatment-naïve acromegalic population. Tumor volume was determined using a rigorous, pre-specified method for MRI evaluation.
Methods: In this international, multicenter, open-label, single-arm study (NCT00690898), treatment-naïve acromegalic patients with GH-secreting pituitary macroadenoma received primary therapy with lanreotide Autogel 120 mg every 28 d for 48 wks. Tumor volume, hormonal status, and safety were assessed at baseline and at 12, 24, and 48 wks. The primary endpoint was % of patients with ≥20% tumor volume reduction (baseline‑wk 48) based on MRI central assessments from 3 readers. The primary analysis used the reader with best standardized sensitivity as defined using repeatability tests.
Results: 90 patients received therapy (baseline mean max tumor diameter 19.0 mm [range 10.6–50.4 mm], tumor volume 2739 mm3, GH 15.0 µg/L, IGF-1 810 µg/L). The primary reader found 56/89 patients (63% [95%CI: 52–73%]) achieved ≥20% tumor volume reduction in the ITT population and 47/63 (75% [62–85%]) in the PP population after 48-wks treatment. On final assessment, GH ≤ 2.5 µg/L was achieved in 58/89 (65% [54–75%]), normalized IGF-1 in 34/88 (39% [28–50%]), and GH/IGF-1 control in 30/88 (34% [24–45%]). Early and sustained mean changes occurred in tumor volume (wk 12, –20%; wk 24, –25%; wk 48, –27%), mirrored by falls in GH (wk 12, –62%; wk 24, –65%; wk 48, –71%) and IGF-1 levels (wk 12, –44%; wk 24, –47%; wk 48, –57%). Most patients reported mild (56/90 [62%]) and/or moderate AEs (36/90 [40%]), but only 5/90 discontinued due to AEs (6%).
Conclusions: In patients with newly-diagnosed GH-secreting pituitary macroadenoma, primary lanreotide Autogel 120 mg therapy achieved early and sustained reductions in pituitary adenoma volume and GH/IGF-1 levels, with a favorable safety profile. These results support further exploring the potential clinical indication of high dose lanreotide Autogel as an initial treatment for GH-secreting pituitary macroadenoma.
Disclosure: PJC: Consultant, Novartis Pharmaceuticals, Speaker, Novartis Pharmaceuticals, Board Member, Ipsen, Speaker, Ipsen, Consultant, Ipsen. JSB: Consultant, Ipsen, Study Investigator, Ipsen, Researcher, Ipsen, Researcher, Novartis Pharmaceuticals, Study Investigator, Novartis Pharmaceuticals. AC: Employee, Ipsen. PM: Employee, Ipsen.
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