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This version published online on March 14, 2006
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2005-2110
A more recent version of this article appeared on June 1, 2006
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Submitted on September 21, 2005
Accepted on March 7, 2006

Predictors of Tumor Shrinkage after Primary Therapy with Somatostatin Analogues in Acromegaly: A Prospective Study in 99 Patients

Annamaria Colao*, Rosario Pivonello, Renata S. Auriemma, Francesco Briganti, Mariano Galdiero, Fabio Tortora, Ferdinando Caranci, Sossio Cirillo, and Gaetano Lombardi

Department of Molecular and Clinical Endocrinology and Oncology, section of Endocrinology, University "Federico II" of Naples; Department of Neurological Sciences, Section of Neuroradiology; University "Federico II" of Naples; Department of Radiology, Section of Neuroradiology, II University of Naples, Italy

* To whom correspondence should be addressed. E-mail: colao{at}unina.it.

Context: Primary treatment with depot octreotide (LAR) and lanreotide (LAN) induces tumor shrinkage in newly diagnosed patients with acromegaly.

Objective: To evaluate clinical predictors of tumor shrinkage.

Design: Analytical, observational, open, prospective.

Subjects: 99 patients: 13 with microadenoma, 86 with macroadenoma (25 enclosed, 32 extra-sellar, 29 invasive).

Main outcome measures: Age, gender, estimated disease duration, body mass index, GH and IGF-I levels, tumor volume at diagnosis and after 12 months of treatment. Percentage of GH, IGF-I and tumor size changes from baseline were also analyzed. Tumor changes were scored as absent (±0-25%) mild (±25.1-50%) moderate (±50.1-75%) or notable (75%).

Interventions: 60 patients (60.6%) received LAR i.m. (20-30 mg every 28 days) and 39 patients (39.4%) received LAN i.m. (60-90 mg every 28 days).

Results: Basal tumor volume and maximal tumor diameter correlated with age, disease duration and GH levels. After 12 months, GH levels were controlled (≤2.5 µg/L) in 57.6%, IGF-I levels in 45.5%, both in 42.4%. Shrinkage was absent in 22 patients (22.2%); mild in 31 (31.1%), moderate in 30 (30.3%) and notable in 14 patients (14.1%). Two patients (not responding to treatment) had a mild tumor increase (by 34% and 31.2%, respectively). Basal and post-treatment tumor volumes were highly correlated (r=0.79, P < 0.0001). At the multi-step regression analysis, the percent IGF-I decrease (t=2.6; P = 0.011) was the best predictor of post-treatment tumor volume followed by patients' age (t=2.1; P = 0.042) and percent GH decrease (t=2.0; P = 0.044).

Conclusions: 75.5% of patients with acromegaly had ≥25% tumor shrinkage after 12 months of primary somatostatin analog therapy: significant increase of tumor mass occurred in only 2.1% of patients (uncontrolled during treatment). Best predictor of tumor shrinkage was post-treatment IGF-l.
Key words: Acromegaly • GH • IGF-I • somatostatin • octreotide • lanreotide




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