Meeting
2018 ASCO Annual Meeting
Ipilimumab and radiation in patients with unresectable melanoma brain metastases: A multicenter, open label, phase-2, Spanish Melanoma Group (GEM) study (NCT-2013-001132-22).
Authors
Jose A. Lopez-Martin
Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain
Jose A. Lopez-Martin , Ana M. Arance , Luis De La Cruz-Merino , Ana Illescas , Izazkun Valduvieco , Alfonso Berrocal , José López Torrecilla , Ivan Marquez Rodas , Maria Teresa Curiel Garcia , Virtudes Soriano , Ana Alvarez , M.L. Chust Vicente , Delvys Rodriguez-Abreu , M.C. Peñas Sanchez , Eva Muñoz-Couselo , Javier Aristu , Antonio Gomez Caamaño , Salvador Martin-Algarra
Organizations
Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain, Medical Oncology. Hospital Clínic de Barcelona, Barcelona, Spain, Hospital Universitario Virgen Macarena, Seville, Spain, Hospital Universitario Virgen Macarena, Sevilla, Spain, Hospital Clínic Barcelona, Barcelona, Spain, Hospital General Universitario de Valencia, Valencia, Spain, Department of Radiation Oncology, General University Hospital of Valencia, Valencia, Spain, Hospital General Universitario Gregorio Marañón, Madrid, Spain, Hospital Universitario Clínico de Santiago, Santiago de Compostela, Spain, Instituto Valenciano de Oncología, Valencia, Spain, Hospital Universitario Gregorio Marañón, Madrid, Spain, Hospital Universitavio Insular De Gran Canaria, Las Palmas, Spain, H. Universitario 12 de Octubre, Madrid, Spain, Medical Oncology Department, Vall d'Hebron University Hospital., Barcelona, Spain, Clinica Universidad de Navarra, Pamplona, Spain, Hospital Universitario de Santiago de Compostela, Santiago de Compostela, Spain
Research Funding
Pharmaceutical/Biotech Company
Background: Laboratory and clinical experiences suggest that radiotherapy may be synergistic with anti-CTLA-4 strategies. This hypothesis is explored in melanoma patients (pts) with brain metastases (BM) not candidate to surgery/radiosurgery. Methods: Single arm phase-2 trial evaluating Ipilimumab (IPI) and whole brain RT (WBRT), in pts with melanoma and unresectable BM. Endpoints: Primary: 1-year overall survival (OS@1y). Secondaries: progression free survival (PFS), objective response rate (ORR) and safety. Main eligibility criteria: first-BM episode, non-suitable for radical therapy; Barthel Index > 10; RTOG-RPA class-2; measurable disease; Karnofsky > 70%; LDH < 2 xULN; no rapid clinical deterioration; dexamethasone < 16 mg/d. Treatment: IPI 3mg/Kg q3weeks (4 cycles); WBRT 30Gy in 10 fractions (or equivalent). Evaluable pts: Safety > 1 IPI dose. Efficacy: complete WBRT and > 1 IPI dose. Trial required 56 evaluable pts to detect an 35% OS@1y, assuming the historical 20% OS in this population (α:0.05, β:0.8; 1-stage Fleming design). Results: From April/2014 to January/2017, 58 pts were included; 51 completed WBRT and > 1 IPI dose. Demographic characteristics: Age (median/range) 63 (37/85). Male/Female 36/22. Karnofsky (100/90; 80/70) 42. 16. BM (1, > 1, nonspecified) 14; 43; 1. Barthel Index ( > 15; 10-15) 56; 2. Steroids at baseline 31 (53,4%). Prior treatments (1, > 1) 20 (34,5%), 9 (15,5%). Previous BRAF/MEKinhibitors 18 (31%). Liver metastases 16 (27,6%). Treatment intensity: WBRT: completed in 55 pts (3 early termination). IPI 4/3/2/1 doses: 31/10/10/7 pts. Efficacy: OS@1y: 31.8% (95%CI 18.8-44.8%). 15 pts are alive > 1 year. Median PFS: 4.8mo (95%CI 2.2-3.4). Median OS 5.8mo (95%CI 3.6-5.9). Safety: Serious AEs: 40 pts (69%). Treatment-related SAEs: 11 pts (19%). IPI-related: ALT/AST (4), diarrhea (4), intestinal perforation (1), headache (1). RT-related: headache and vomiting (1). Conclusions: Concomitant IPI+WBRT is feasible and there were no unexpected safety issues. Steroids at baseline do not impair the effect of IPI in this population. OS@1y in this trial is higher than the historical results. Clinical trial information: 2013-001132- 22.
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Abstract Details
Session Type
Poster Session
Session Title
Melanoma/Skin Cancers
Track
Melanoma/Skin Cancers
Sub Track
Advanced/Metastatic Disease
Clinical Trial Registration Number
2013-001132- 22
Citation
J Clin Oncol 36, 2018 (suppl; abstr 9546)
DOI
10.1200/JCO.2018.36.15_suppl.9546
Abstract #
9546
Poster Bd #
373
Abstract Disclosures
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