Detalle Publicación

GRAY-B: An open label multicenter phase-2 GEM study on ipilimumab and radiation in patients with melanoma and brain metastases

Autores: Lopez Martin, J. A.; de la Cruz Merino, L.; Arance Fernandez, A. M.; Illescas, A.; Valduviecu Ruiz, I.; Berrocal, A. ; Lopez-Torrecilla, J.; Marquez Rodas, I.; Soriano Teruel, M. V.; Alvarez Gonzalez, A.; Chust Vicente, M. L.; Rodriguez Abreu, D.; Cabrera, R.; Penas Sanchez, M. C.; Curiel, T.; Muñoz Couselo, E.; Aristu Mendioroz, José Javier; Gomez-Caamano, A.; Medina Martinez, J.; Martín Algarra, Salvador
Título de la revista: ANNALS OF ONCOLOGY
ISSN: 0923-7534
Volumen: 27
Número: Supl. 6
Páginas: 1118P
Fecha de publicación: 2016
Background: Estimated median overall survival (OS) in patients (pts) with brain metastases (BM) ranges between 1.8-10.5 months (mo). Ipilimumab (IPI) has shown activity against mel-BM. Radiation (RT) might be synergistic to anti-CTLA-4 blockade through an `abscopal¿ effect. Methods: Open label single stage multicenter phase 2 study, assuming a historical 20% 1-year survival rate (1y SR) with RT. Target sample size: 56 evaluable pts. Target 1y SR: 35% (¿= 0.05, ß= 0.2). Objectives: Primary: 1y SR; Secondary: progression free survival (PFS); OS; objective response rate (mWHO); safety and feasibility. Treatment: IPI 3 mg/Kg iv q 3 weeks (4 cycles); whole brain RT (WBRT) 30 Gy in 10 fractions (or equivalent), started between C1 and C2. Main eligibility: First episode of BM in mel pts; Karnofsky PS > 70%; Barthel Index > 10; RTOG-RPA class 2; measurable disease; LDH < 2 x ULN; not eligible for radical therapy; not experiencing rapid clinical deterioration; not requiring dexamethasone > 16 mg/d (or equivalent). Results: This is a preliminary analysis after recruiting 43/56 pts (Apr 2014 - Mar 2016). Demographical characteristics are shown in the table.