PMID- 21324953
OWN - NLM
STAT- MEDLINE
DCOM- 20111123
LR  - 20220330
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 22
IP  - 8
DP  - 2011 Aug
TI  - Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) 
      expanded-access study: a large open-label study in diverse community settings.
PG  - 1812-23
LID - 10.1093/annonc/mdq651 [doi]
AB  - BACKGROUND: The European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) 
      expanded-access study provided sorafenib to advanced renal cell carcinoma (RCC) 
      patients in whom previous systemic therapy had failed. The study assessed the 
      safety and use of sorafenib for the treatment of advanced RCC in a large 
      community-based patient population across 11 countries in Europe. PATIENTS AND 
      METHODS: EU-ARCCS was a single-arm, open-label trial of sorafenib in advanced RCC 
      patients. End points included safety, time to progression, progression-free 
      survival (PFS), and disease control rate (DCR). Subgroup analyses included age, 
      Eastern Cooperative Oncology Group performance status, histology, prior therapy, 
      and number and sites of metastases. RESULTS: About 1159 advanced RCC patients 
      were enrolled. Most patients (94%) experienced drug-related adverse events (AEs) 
      of any grade, with the most common grade >/=3 AEs including hand-foot skin reaction 
      (13%), diarrhea (7%), fatigue (7%), hypertension (6%), and rash/desquamation 
      (5%). The incidence of AEs in the subgroups was similar to that in the overall 
      population. Median PFS was 6.6 months; DCR at >/=8 and >/=12 weeks was 85% and 78%, 
      respectively. CONCLUSIONS: The sorafenib safety profile in European 
      community-based practice settings was similar to that reported in clinical 
      trials. The heterogeneous advanced RCC patient population in EU-ARCCS permitted 
      assessment of sorafenib in important subpopulations of advanced RCC patients.
FAU - Beck, J
AU  - Beck J
AD  - Johannes Gutenberg University Medical Center, Mainz, Germany.
FAU - Procopio, G
AU  - Procopio G
FAU - Bajetta, E
AU  - Bajetta E
FAU - Keilholz, U
AU  - Keilholz U
FAU - Negrier, S
AU  - Negrier S
FAU - Szczylik, C
AU  - Szczylik C
FAU - Bokemeyer, C
AU  - Bokemeyer C
FAU - Bracarda, S
AU  - Bracarda S
FAU - Richel, D J
AU  - Richel DJ
FAU - Staehler, M
AU  - Staehler M
FAU - Strauss, U P
AU  - Strauss UP
FAU - Mersmann, S
AU  - Mersmann S
FAU - Burock, K
AU  - Burock K
FAU - Escudier, B
AU  - Escudier B
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110215
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzenesulfonates)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Pyridines)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Benzenesulfonates/administration & dosage/*adverse effects/therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy
MH  - *Compassionate Use Trials
MH  - Disease-Free Survival
MH  - Europe
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Niacinamide/analogs & derivatives
MH  - Phenylurea Compounds
MH  - Pyridines/administration & dosage/*adverse effects/therapeutic use
MH  - Sorafenib
MH  - Treatment Outcome
EDAT- 2011/02/18 06:00
MHDA- 2011/12/13 00:00
CRDT- 2011/02/18 06:00
PHST- 2011/02/18 06:00 [entrez]
PHST- 2011/02/18 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - S0923-7534(19)38382-6 [pii]
AID - 10.1093/annonc/mdq651 [doi]
PST - ppublish
SO  - Ann Oncol. 2011 Aug;22(8):1812-23. doi: 10.1093/annonc/mdq651. Epub 2011 Feb 15.