Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly.

OBJECTIVE

To evaluate GH and IGF-I control and tumour shrinkage in newly diagnosed patients with acromegaly treated first-line with lanreotide-Autogel (ATG) 120 mg. Design Open, prospective.

PATIENTS

Twenty-six patients (17 women, aged 31-70 years): eight enclosed and 12 extrasellar (eight invasive) macroadenomas and six microadenomas (one invasive). ATG 120 mg initially given every 4 weeks for 12 weeks; then intervals between injections increased to every 6 or 8 weeks if GH levels were <or= 2.5 or < 1 microg/l (equal to 6.5 and 2.6 mU/l), respectively.

RESULTS

Final dosage was ATG 120 mg every 4 weeks in nine patients (34.6%), every 6 weeks in eight patients (30.8%) and every 8 weeks in the remaining nine patients (34.6%). After 12 months, both GH and IGF-I were controlled in 14 patients (53.8%). The mean tumour volume decreased from 1405 +/- 1827 mm(3) at study entry to 960 +/- 1381 mm(3) after 6 months, and 799 +/- 1161 mm(3) after 12 months (P < 0.0001). Overall tumour shrinkage was 35.8 +/- 28.1% after 6 months and 48.4 +/- 27.6% after 12 months. After 12 months, 20 patients (76.9%) achieved > 25% tumour shrinkage: 12 of 14 with controlled disease (85.7%) and 8 of 12 with noncontrolled disease (66.7%; P = 0.49). Hyperhydrosis, paresthesiae and arthralgias significantly reduced after treatment. No patient withdrew from the study because of adverse events.

CONCLUSION

ATG 120 mg in newly diagnosed patients with acromegaly controls GH and IGF-I secretion in 53.8% and induces >or= 25% tumour shrinkage in 76.9% during a 12-month period. The treatment was associated with improvement of clinical symptoms and with a good safety profile.