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The Journal of clinical endocrinology and metabolism · 2024

Personalized Medicine in Acromegaly: The ACROFAST Study.

СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Marques-Pamies Montserrat, Gil Joan, Sampedro-Nuñez Miguel, Valassi Elena, Biagetti Betina, Giménez-Palop Olga, Hernández Marta, Martínez Silvia, Carrato Cristina, Villar-Taibo Rocío, Araujo-Castro Marta, Blanco Concepción, Simón-Muela Inmaculada, Simó-Servat Andreu, Xifra Gemma, Vázquez Federico, Pavón Isabel, Rosado José Antonio, García-Centeno Rogelio, Zavala Roxana, Hanzu Felicia Alexandra, Mora Mireia, Aulinas Anna, Vilarrasa Nuria, Librizzi Soledad, Calatayud María, de Miguel Paz, Alvarez-Escola Cristina, Picó Antonio, Salinas Isabel, Fajardo-Montañana Carmen, Cámara Rosa, Bernabéu Ignacio, Jordà Mireia, Webb Susan M, Marazuela Mónica, Puig-Domingo Manel

Аннотация

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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты