Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage.
BACKGROUND
Neurosurgery is regarded as the first-line treatment of acromegaly. Because of its low cure rate in macro and invasive adenoma, the role of primary medical treatment is debated.


OBJECTIVE
Our objective was to evaluate primary pharmacological treatment in acromegaly.


METHODS
We conducted an open prospective study at two Italian tertiary level centers.


METHODS
We studied 67 consecutive patients (36 women; age, 54.9 +/- 14.2 yr; 72% bearing macroadenoma).


METHODS
Individually tailored octreotide LAR (OCLAR) was administered.


METHODS
Outcomes included safe GH (<2.5 mug/liter), normal age-matched IGF-I levels, and tumor shrinkage.


RESULTS
After a median follow-up of 48 months (range, 6-108 months), safe GH levels and normal age-matched IGF-I values were obtained by 68.7 and 70.1% of patients, respectively. Hormonal endpoints 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 mm(3) (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 patients and was progressively reduced to empty sella in five patients; apparent magnetic resonance imaging 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.
Cozzi
Renato
R
Division of Endocrinology, Ospedale Niguarda, Viale Ezio 5, I-20149 Milan, Italy. renatocozzi@tiscali.it
Montini
Marcella
M
Attanasio
Roberto
R
Albizzi
Mascia
M
Lasio
Giovanni
G
Lodrini
Sandro
S
Doneda
Paola
P
Cortesi
Liana
L
Pagani
Giorgio
G
D000172:Acromegaly / Q000188:drug therapy*; D000236:Adenoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001660:Biliary Tract Diseases / Q000139:chemically induced; D003692:Delayed-Action Preparations; D018491:Dopamine Agonists / Q000494:pharmacology; D005260:Female; D019382:Human Growth Hormone / Q000378:metabolism; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D010911:Pituitary Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D013739:Testosterone / Q000097:blood
D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D018491:Dopamine Agonists; D019382:Human Growth Hormone; D013739:Testosterone; D007334:Insulin-Like Growth Factor I; D015282:Octreotide