Efficacy and safety of lanreotide in combination with cabergoline in clinical practice in patients with active acromegaly

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 88-129-Acromegaly & Prolactinoma
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-97
Ricardo Vilchez1, Ignacio Bernabeu*2, Concepción Blanco3, Fernando Cordido4, Miguel Paja5, Rosa Casany6, Carmen Fajardo7, Silvia Maraver8, Tomás Martín9, Juan Antonio García Arnes10, Pablo Fernández Catalina11, María Purificación Martínez de Icaya12, Antonio Picó13, Gemma Sesmilo14, Mónica Marazuela15, Alfonso Soto16 and on Behalf Of The ACROCOMB Study Group17
1Hospital Universitario Virgen de las Nieves, Granada, Spain, 2Hospital Clinico Universitario de Santiago (CHUS), Santiago de Compostela, Spain, 3Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain, 4Hospital Universitario A Coruña, A Coruña, Spain, 5Hospital Universitario de Basurto, Bilbao, Spain, 6Hospital Lluís Alcanyís, Xàtiva, Spain, 7Hospital Universitario La Ribera, Alzira, Spain, 8Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain, 9Hospital Universitario Virgen Macarena, Sevilla, Spain, 10Hospital Universitario Carlos Haya, Málaga, Spain, 11Hospital Universitario de Pontevedra, Pontevedra, Spain, 12Hospital Severo Ochoa, Leganés, Spain, 13Hospital General Universitario de Alicante, Alicante, Spain, 14Institut Dexeus, Barcelona, Spain, 15Hospital Universitario La Princesa, Madrid, Spain, 16Hospital Universitario Virgen del Rocío, Sevilla, Spain, 17ACROCOMB Study, Spain
Introduction:

ACROCOMB is a retrospective Spanish Multicenter study designed to evaluate the efficacy (biochemical control and tumor size) and safety of lanreotide (LAN) treatment combined with cabergoline (CAB), or pegvisomant (PEG) in acromegalic patients in routine clinical practice.

Methods:

Sixty-four patients treated with LAN+CAB (54% of the 119 patients in the ACROCOMB study) at 44 Spanish Endocrinology Departments were analyzed. The LAN + PEG subgroup is presented separately.

Results:

There were 33% males; median age was 50.4 years and mean time from diagnosis 5.9±6.9 years. Mean maximum tumour diameter at diagnosis was 21.9±11.5 mm. Eighty-three percent of patients had surgery (16% ≥2 times) and 38% had radiotherapy (fractionated stereotactic: 16%, conventional: 11%, radiosurgery: 11%). Medical treatment immediately prior to LAN+CAB was LAN (57%), octreotide (10%) and dopamine agonist (15%); 17% were not receiving any treatment. This last group of patients was diagnosed with mixed (GH and PRL) tumours and LAN+CAB was their first medical treatment. Additional reasons for administering LAN+CAB were hormonal control improvement (70%), patient convenience (6%) and other (14%). In 8% of patients there was more than one reason for combined treatment. Median duration of LAN+CAB treatment was 1.5 years (0.1–6). Median monthly LAN doses were 90 mg (60–120) at baseline and 120 mg (60–240) at the end of the study (EOS). Some patients received an extended LAN treatment regimen (q6w or q8w) at baseline (13%) and at EOS (14%). Furthermore, 42% of patients were receiving <120 mg LAN at baseline and 22% at EOS. Median weekly CAB doses were 1 mg (0.25–5) at baseline and 1.4 mg (0.25–5) at EOS. Median GH values were 4 ng/ml (0–400) at baseline, 3 ng/ml (0–135) at 6 months, and 2 ng/ml (0–103) at EOS. Median IGF-I values were 144% ULN (15–505%) at baseline and decreased to 115% ULN (13–557%) at 6 months and 105% ULN (13–557%) at EOS; p<0.0001. Median PRL also significantly decreased from 83% ULN (0–4000) at baseline to 7% ULN (0–233) at 6 months; p<0.0001, and to 5% ULN (0–807) at EOS; p<0.0001. At baseline 31% of patients had normal GH (<2.5 ng/ml), 14% had normal age-adjusted IGF-I and 54% had normal PRL values. At EOS, normalized values were reported in 51% (GH), 46% (IGF-I), and 94% (PRL) of patients. At EOS 35 of 43 (81%) patients had residual tumor; tumor size decreased in 8 patients and remained stable in 26 patients. There were no changes in hepatic, cardiac or glycemic parameters. At EOS 48 (75%) patients continued receiving LAN+CAB. Reasons for discontinuation included lack of efficacy (13%), patient decision (5%), patient death (2%) and postradiotherapy improvement (2%).

Conclusion:

The LAN+CAB combination is well-tolerated in clinical practice with efficacy similar to what has been reported in the literature, albeit a lower CAB dose. LAN+CAB increases disease control in comparison with monotherapy alone.

Disclosure: FC: Clinician, Novartis Pharmaceuticals, Clinical Researcher, Ipsen. PF: Clinician, Novartis Pharmaceuticals, Clinician, Ipsen. AP: Clinician, Pfizer, Inc., Clinical Researcher, Novartis Pharmaceuticals. Nothing to Disclose: RV, IB, CB, MP, RC, CF, SM, TM, JAG, MPM, GS, MM, AS, OBOTA

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm