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Multicenter Study
. 2024 Dec 18;110(1):30-40.
doi: 10.1210/clinem/dgae444.

Personalized Medicine in Acromegaly: The ACROFAST Study

Montserrat Marques-Pamies  1 , Joan Gil  2   3 , Miguel Sampedro-Nuñez  4 , Elena Valassi  2   3   5 , Betina Biagetti  6 , Olga Giménez-Palop  7 , Marta Hernández  8   9 , Silvia Martínez  10 , Cristina Carrato  11 , Rocío Villar-Taibo  12 , Marta Araujo-Castro  13   14 , Concepción Blanco  15 , Inmaculada Simón-Muela  16   17   18   19 , Andreu Simó-Servat  20 , Gemma Xifra  21 , Federico Vázquez  5 , Isabel Pavón  22 , José Antonio Rosado  22 , Rogelio García-Centeno  23 , Roxana Zavala  16 , Felicia Alexandra Hanzu  24   25 , Mireia Mora  24   25 , Anna Aulinas  3   26 , Nuria Vilarrasa  19   27   28 , Soledad Librizzi  29 , María Calatayud  29 , Paz de Miguel  30 , Cristina Alvarez-Escola  31 , Antonio Picó  32   33 , Isabel Salinas  5 , Carmen Fajardo-Montañana  34 , Rosa Cámara  35 , Ignacio Bernabéu  12 , Mireia Jordà  2 , Susan M Webb  3   26   36 , Mónica Marazuela  4 , Manel Puig-Domingo  2   3   5   36
Affiliations
Multicenter Study

Personalized Medicine in Acromegaly: The ACROFAST Study

Montserrat Marques-Pamies et al. J Clin Endocrinol Metab. .

Erratum in

Abstract

Context: Medical treatment of acromegaly is currently performed through a trial-and-error approach using first-generation somatostatin receptor ligands (fgSRLs) as first-line drugs, with an effectiveness of about 50%, and subsequent drugs are indicated through clinical judgment. Some biomarkers can predict fgSRLs response.

Objective: Here we report the results of the ACROFAST study, a clinical trial in which a protocol based on predictive biomarkers of fgSRLs was evaluated.

Methods: This was a prospective trial (21 university hospitals) comparing the effectiveness and time-to-control of 2 treatment protocols during 12 months: (A) a personalized protocol in which the first options were fgSRLs as monotherapy or in combination with pegvisomant, or pegvisomant as monotherapy depending on the short acute octreotide test (sAOT) results, tumor T2 magnetic resonance (MRI) signal or immunostaining for E-cadherin; and (B) a control group with treatment always started by fgSRLs and the other drugs included after demonstrating inadequate control.

Results: Eighty-five patients participated; 45 in the personalized and 40 in the control group. More patients in the personalized protocol achieved hormonal control compared to those in the control group (78% vs 53%, P < .05). Survival analysis revealed a hazard ratio for achieving hormonal control adjusted by age and sex of 2.53 (CI, 1.30-4.80). Patients from the personalized arm were controlled in a shorter period of time (P = .01).

Conclusion: Personalized medicine is feasible using a relatively simple protocol, and it allows a higher number of patients to achieve control in a shorter period of time.

Keywords: acromegaly; clinical trial; first-generation somatostatin receptor ligands; medical treatment; personalized therapy; therapeutic response prediction.

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Figures

Figure 1.
Figure 1.
Treatment algorithms. After inclusion, patients were treated according to the standard treatment or a personalized treatment based on the short acute octreotide test (sAOT), T2-MRI intensity, and the expression of E-cadherin. Abbreviations: fgSRLs, first-generation somatostatin receptor ligands; GH, growth hormone; GH2h, growth hormone value 2 hours after the short acute octreotide test; MRI, magnetic resonance imaging; PEGV, pegvisomant; %∇GH, percentage GH variation after the short acute octreotide test; (PEGV).
Figure 2.
Figure 2.
Acromegaly control at the end of the study.
Figure 3.
Figure 3.
Survival analysis to evaluate differences in time-to-control between groups.
Figure 4.
Figure 4.
Personalized presurgical algorithm predictive ability to identify first-generation somatostatin receptor ligand (fgSRL) response. Abbreviation: AUC, area under the curve.
See this image and copyright information in PMC

Comment in

References

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