Sorafenib treatment of advanced renal cell carcinoma patients in daily practice: the large international PREDICT study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinická studie, časopisecké články, multicentrická studie, práce podpořená grantem
PubMed
25444666
DOI
10.1016/j.clgc.2014.07.007
PII: S1558-7673(14)00154-2
Knihovny.cz E-zdroje
- Klíčová slova
- Clinical practice, Multikinase inhibitor, Noninterventional study, Targeted agent, Tolerability,
- MeSH
- ambulantní zařízení MeSH
- dospělí MeSH
- fenylmočovinové sloučeniny aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- karcinom z renálních buněk farmakoterapie etnologie patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- mladiství MeSH
- mladý dospělý MeSH
- nádory ledvin farmakoterapie etnologie patologie MeSH
- niacinamid aplikace a dávkování škodlivé účinky analogy a deriváty terapeutické užití MeSH
- prospektivní studie MeSH
- protinádorové látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sorafenib MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- fenylmočovinové sloučeniny MeSH
- niacinamid MeSH
- protinádorové látky MeSH
- sorafenib MeSH
BACKGROUND: Patients with advanced renal cell carcinoma in routine clinical practice can differ considerably from those in phase III studies. PATIENTS AND METHODS: PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with sorafenib) was a prospective, noninterventional study of open-label sorafenib for the treatment of advanced RCC conducted in 18 countries. Patient characteristics, therapy duration, tumor status, and tolerability were assessed at baseline and during routine follow-up. RESULTS: Overall, 2599 patients were evaluable for safety and 2311 for efficacy. The diverse population included patients with brain metastases (5%), non-clear-cell histologies (17%), high Memorial Sloan-Kettering Cancer Center risk score (11%), poor Eastern Cooperative Oncology Group performance status (PS ≥ 2, 29%), and patients with no previous nephrectomy (16%) or no previous systemic therapy (37%). The median duration of sorafenib therapy was 7.3 months and was similar in clinically relevant subgroups (eg, patients with PS 2, brain metastases, or concomitant hypertension or diabetes [range, 6.7-7.0 months]). The median duration of therapy was shorter for patients with PS 3 or non-clear-cell histologies (4.6 and 4.8 months, respectively). The most common drug-related adverse events were hand-foot skin reaction (20%), diarrhea (17%), and rash (8%). CONCLUSION: Sorafenib was generally well tolerated and provided clinical benefit in a large, diverse population of patients with advanced RCC treated in routine clinical practice.
Affiliated Cancer Hospital of Fudan University Shanghai China
Asan Medical Center Seoul Korea
Bayer HealthCare Leverkusen Germany
Bayer HealthCare Wuppertal Germany
Beijing Cancer Hospital Beijing China
Cancer Institute and Hospital Chinese Academy of Medical Sciences Beijing China
Charles University Prague 1st Faculty of Medicine Prague Czech Republic
Department of Urology Medical University Innsbruck Innsbruck Austria
Hospital Británico de Buenos Aires Buenos Aires Argentina
Institut Gustave Roussy Villejuif France
National Cancer Institute Bratislava Slovakia
National Center for Tumor Diseases University Medical Center Heidelberg Heidelberg Germany
Citace poskytuje Crossref.org
