Efficacy and Safety of Lanreotide in Combination with Pegvisomant in Clinical Practice in Patients with Active Acromegaly with Monotherapy Failure

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-96
Eva Venegas*1, Tomás Lucas2, Mónica Marazuela3, Guillem Cuatrecasas4, María Angeles Galvez5, Enrique Romero6, Francisco M. Morales-Pérez7, Susan M. Webb8, Betina Biaggeti9, Juan José Diaz10, José Antonio Mato11, Ricardo Vilchez12, Ignacio Bernabeu13, Miguel Paja14, Antonio Pico15, Manuel Puig Domingo16, Alfonso Soto17 and on Behalf Of The ACROCOMB Study Group18
1Instituto de Biomedicina de Sevilla (IBiS), Consejo Superior de Investigaciones Científicas, Endocrinology Unit of Virgen del Rocío University Hospital, University of Seville, Sevilla, Spain, 2Hospital Universitario Puerta de Hierro, Majadahonda, Spain, 3Hospital Universitario La Princesa, Madrid, Spain, 4Clínica Teknon, Barcelona, Spain, 5Hospital Reina Sofía, Córdoba, Spain, 6Hospital Clínico Universitario, Valladolid, Spain, 7Hospital Universitario Infanta Cristina, Badajoz, Spain, 8Hospital Sant Pau, Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBER-ER, Unidad 747), ISCIII and Universitat Autònoma de Barcelona (UAB), Barcelona, Spain, 9Hospital Universitario Vall d’Hebron, Barcelona, Spain, 10Hospital Universitario Ramón y Cajal, Madrid, Spain, 11Complexo Hospitalario de Ourense, Ourense, Spain, 12Hospital Universitario Virgen de las Nieves, Granada, Spain, 13Hospital Clinico Universitario de Santiago (CHUS), Santiago de Compostela, Spain, 14Hospital Universitario de Basurto, Bilbao, Spain, 15Hospital General Universitario de Alicante, Alicante, Spain, 16Hospital Universitario Germans Trias i Pujol, Badalona, Spain, 17Hospital Universitario Virgen del Rocío, Sevilla, Spain, 18ACROCOMB Study, Spain
Introduction:

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

Methods:

52 patients with active acromegaly treated with LAN+PEG (45% of the 119 patients in the ACROCOMB study) at 44 Spanish Endocrinology Departments were analyzed. Cabergoline results are presented separately.

Results:

40% of the 52 patients were male and the median age was 42.5 years. Mean time from diagnosis was 7.2±7.5 years. Mean maximum tumor diameter at diagnosis was 25.5±9.9 mm. 92% of patients had surgery (15% twice) and 65% had radiotherapy (fractionated stereotactic: 37%, conventional: 14%, radiosurgery: 15%). Immediately prior to LAN+PEG, 57% of patients were receiving LAN, 4% octreotide, 35% PEG, 2% cabergoline and 1 patient was not receiving treatment. At baseline the median IGF-I value was 156% ULN (15–534%) with normal IGF-I values in 15% of patients. LAN+PEG was indicated for monotherapy failure (88%), tumor volume control (12%), headache (8%), financial savings (2%), and patient convenience (2%). 14% of patients received LAN+PEG for >1 reason. Median LAN+PEG treatment duration was 2.1 years (range 0.4–6.3). Median monthly LAN doses were similar at baseline (120 mg [60–240]) and at end of study (EOS) (120 mg [30–240]). At the EOS, 25% of patients were receiving extended LAN treatment (q6w or q8w instead of standard q4w) and 21% were receiving LAN <120 mg/month, compared with 20% and 17% of patients respectively at baseline. Median weekly PEG doses were 70 mg (range 10–210) at baseline and 105 mg (range 30–210) at EOS. Median IGF-I values decreased by 6 months (83% ULN [11–236%] p<0.0001 vs baseline) and remained stable at EOS (84% ULN [23–345%] p<0.0001 vs baseline). At EOS 71% of patients had normal IGF-I values; drug infradosing might explain lack of normalization in the other patients. At EOS there were visible tumor remains in 32 of 40 (80%) patients: tumor size decreased in 3 patients and remained stable in 27 patients. No changes were reported in hepatic, cardiac, glycemic parameters. 41 (79%) patients continue receiving LAN+PEG at EOS. Discontinuation reasons included improvement after radiotherapy (6%), lack of efficacy (4%), patient decision (4%), patient death (2%) and safety concerns (2%). Status at EOS was unknown in 2 patients.

Conclusion:

The combination of LAN and PEG is well-tolerated and has high efficacy in clinical practice in patients not well controlled with monotherapy in routine clinical practice. Neither significant liver enzyme elevations nor increases in tumor volume were observed.

Disclosure: SMW: Clinician, Ipsen. AP: Clinical Researcher, Pfizer, Inc., Clinician, Novartis Pharmaceuticals. MP: Clinical Researcher, Pfizer, Inc., Clinician, Novartis Pharmaceuticals. Nothing to Disclose: EV, TL, MM, GC, MAG, ER, FMM, BB, JJD, JAM, RV, IB, MP, AS, OBOTA

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

Sources of Research Support: Sponsored by Spanish Society of Endocrinology and Nutrition (SEEN). Funding by Ipsen Pharma, Spain.