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Submitted on October 26, 2005
Accepted on January 25, 2006
Division of Endocrinology (RC, RA) and Neuroradiology (PD), Ospedale Niguarda, I-20162 Milan, Italy; Department of Neurosurgery (GL, SL), Neurological Institute Carlo Besta, I-20133 Milan, Italy; Division of Endocrinology (RA, MM, MA, LC, GP), Ospedali Riuniti, I-24100 Bergamo, Italy
* To whom correspondence should be addressed. E-mail: renatocozzi{at}tiscali.it.
Context: neurosurgery is regarded as the first-line treatment of acromegaly. Due to its low cure rate in macro and invasive adenoma, the role of primary medical treatment is debated.
Objective: to evaluate primary pharmacological treatment in acromegaly.
Design: open prospective study.
Setting: two Italian tertiary level centers.
Patients: 67 consecutive patients (36 women, 54.9 ± 14.2 yr, 72% bearing macroadenoma).
Intervention: individually tailored octreotide LAR (OCLAR).
Main outcome measures: safe GH (< 2.5 µg/L), normal age-matched IGF-I levels, and tumor shrinkage.
Results: after a median follow-up of 48 months (range 6-108), safe GH levels and normal age-matched IGF-I values were obtained by 68.7%, and 70.1% of patients, respectively. Hormonal end-points were achieved regardless of basal levels and early results were predictive of outcome. Tumor shrank in 82.1% of patients by 62 ± 31% (range 0-100), decreasing from 2101 ± 2912 to 1010 ± 2196 mm3 (P < 0.0001). The higher the basal GH values and the greater the GH/IGF-I changes on treatment, the greater the tumor shrinkage. Tumor disappeared in three and was progressively reduced to empty sella in five patients; apparent MRI cavernous sinus invasion disappeared in three. In males testosterone increased, restoring eugonadism in 64% of hypogonadal patients.
Conclusions. The efficacy on GH/IGF-I levels in unselected patients and the outstanding volumetric control indicate that treatment with OCLAR may be the first therapeutic approach to all acromegalic patients not amenable to surgical cure. Tumor shrinkage might also encourage the evaluation of primary OCLAR adoption in patients with initial visual field defects.
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