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Prospective randomized phase-II trial of ipilimumab/nivolumab versus standard of care in non-clear cell renal cell cancer - results of the SUNNIFORECAST trial
L. Bergmann, L. Albiges, M. Ahrens, M. Gross-Goupil, E. Boleti, G. Gravis, A. Fléchon, MO. Grimm, J. Bedke, P. Barthélémy, D. Castellano, B. Mellado, P. Ivanyi, S. Rottey, A. Flörcken, C. Suarez, P. Maroto, V. Grünwald, SF. Oosting, J. Kopecky,...
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze II, srovnávací studie
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- ipilimumab * aplikace a dávkování škodlivé účinky MeSH
- karcinom z renálních buněk * farmakoterapie patologie mortalita MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory ledvin * farmakoterapie patologie mortalita MeSH
- nivolumab * aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- standardní péče MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Non-clear cell renal cell cancers (nccRCCs) are a heterogeneous group of more than 20 different entities, but are rarely included in large, randomized trials. Tyrosine kinase inhibitors with or without immune checkpoint inhibition are considered as a standard of care (SOC), but optimal treatment is not yet defined. We designed the first prospective randomized trial comparing ipilimumab/nivolumab to SOC. PATIENTS AND METHODS: We randomized adult patients with previously untreated advanced or metastatic nccRCC 1:1 to nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by fixed dose nivolumab of 240 mg every 2 weeks or 480 mg every 4 weeks or to SOC. Patients were stratified by histology and by IMDC risk score. Central pathology review was mandatory. The primary endpoint was the overall survival (OS) rate at 12 months, secondary endpoints included median OS, response rate, progression-free survival (PFS), safety and quality of life. RESULTS: In total, 157 patients were assigned to receive ipilimumab/nivolumab, and 152 to SOC. The 12-month survival rate was 78% with ipilimumab/nivolumab [95% confidence interval (CI) 71-84%] compared to 68% with SOC (95% CI 60-75%, P = 0.026). Median OS was 33.2 months versus 25.2 months, P = 0.163 [HR 0.81 (0.61-1.099)]. PFS was similar in both arms [HR 0.99 (0.77-1.28)]. The ORR was 32.8% versus 19.3%. No major differences between papillary and non-papillary RCC subtypes were observed for any endpoint. Exploratory analysis showed a significant OS advantage [HR 0.56 (95% CI 0.37-0.86)] associated with a PD-L1 CPS score ≥1. Treatment discontinuation due to toxicity occurred in 27 patients (17%) with ipilimumab/nivolumab and 13 patients (9%) with SOC. CONCLUSIONS: Ipilimumab/nivolumab demonstrated a significantly longer OS at the 12-month milestone and an acceptable toxicity profile. Our results therefore underline a relevant clinical benefit of ipilimumab/nivolumab in previously untreated nccRCC entities compared to current SOC.
Centre Léon Bérard Lyon France
Centre Régional de Lutte contre le Cancer François Baclesse Caen France
Clinic for Urology and Clinic for Medical Oncology University Hospital Essen Germany
Comprehensive Cancer Center Erlangen EMN Erlangen Germany
Department of Health Sciences University of Applied Sciences Fulda Germany
Department of Medical Oncology Ghent University Hospital Ghent Belgium
Department of Urology Eberhard Karls University Tübingen Tübingen Germany
Department of Urology Saarland University Homburg Saar Germany
Erlangen University Hospital Department of Urology and Pediatric Urology Erlangen Germany
Faculty Hospital Hradec Kralove Hradec Kralove Czech Republic
Hospital Center Departmental De Vendée La Roche sur Yon France
Hospital Clinic de Barcelona Barcelona Spain
Hospital Universitario Madrid Spain
Institut Gustave Roussy Paris France
Medical Clinic 2 University Hospital Frankfurt Frankfurt Germany
Medical Oncology Centre Hospitalier Universitaire de Bordeaux Bordeaux France
Medical Oncology Institut de Cancérologie Strasbourg Europe Strasbourg France
Medical School Department of Hematology and Oncology Hanover Germany
Netherlands Cancer Institute Amsterdam the Netherlands
Rechts der Isar Medical Center Technical University of Munich Munich Germany
Royal Free London NHS Foundation Trust London UK
Sant Pau Hospital Barcelona Spain
The Christie NHS Foundation Trust Manchester UK
University Hospital Münster Clinic for Urology Münster Germany
University Hospital NCT Heidelberg Heidelberg Germany
University Medical Center Greifswald Clinic for Urology Greifswald Germany
University Medical Centre Groningen University of Groningen Groningen the Netherlands
Citace poskytuje Crossref.org
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