Objective: To investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas.
Design: A prospective, randomised study.
Methods: After a baseline evaluation, patients were randomly assigned to 4-month preoperative treatment with lanreotide (starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8 if mean GH >2.5 microg/l on GH day curves; pretreatment group, Group 1) or to transsphenoidal surgery (direct surgery group, Group 2). Cure was evaluated 4 months postoperatively primarily by fasting IGF1 less than or equal to age-adjusted upper limit of normal.
Results: A pool of 108 patients was randomly divided into two groups. Five patients in each group were lost to follow-up during the study period, so 49 patients in each group were analysed. At baseline, no difference was observed between the two groups. Cure was established in 24 of 49 (49.0%, 95% confidence interval (CI), 35.0-63.0%) pretreated patients (Group 1) versus 9 of 49 (18.4%, 95% CI, 7.6-29.2%) direct surgery patients (Group 2; P=0.001). Surgical morbidity was recorded in 12 patients (12.2%) and was similar in Group 1 and 2 patients (14.3 and 10.2% respectively; P=0.538). The postoperative hospital stay was similar between groups: being 4.5+/-1.6 days in Group 1 vs 4.8+/-1.9 days in Group 2 (P=0.328).
Conclusions: Pretreatment with lanreotide before transsphenoidal surgery improves surgical cure rates in patients with GH-secreting pituitary macroadenomas. Pretreatment does not affect surgical complications or duration of hospital stay (ClinicalTrials.gov number, NCT00993356).