Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings.
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Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings. / Beck, J; Procopio, G; Bajetta, E; Keilholz, U; Negrier, S; Szczylik, C; Bokemeyer, Carsten; Bracarda, S; Richel, D J; Staehler, M; Strauss, U P; Mersmann, S; Burock, K; Escudier, B.
In: ANN ONCOL, Vol. 22, No. 8, 8, 01.08.2011, p. 1812-1823.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings.
AU - Beck, J
AU - Procopio, G
AU - Bajetta, E
AU - Keilholz, U
AU - Negrier, S
AU - Szczylik, C
AU - Bokemeyer, Carsten
AU - Bracarda, S
AU - Richel, D J
AU - Staehler, M
AU - Strauss, U P
AU - Mersmann, S
AU - Burock, K
AU - Escudier, B
PY - 2011/8/1
Y1 - 2011/8/1
N2 - 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.
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.
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Treatment Outcome
KW - Europe
KW - Age Factors
KW - Disease-Free Survival
KW - Neoplasm Staging
KW - Antineoplastic Agents/administration & dosage/adverse effects/therapeutic use
KW - Benzenesulfonates/administration & dosage/adverse effects/therapeutic use
KW - Carcinoma, Renal Cell/drug therapy
KW - Compassionate Use Trials
KW - Kidney Neoplasms/drug therapy
KW - Pyridines/administration & dosage/adverse effects/therapeutic use
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Treatment Outcome
KW - Europe
KW - Age Factors
KW - Disease-Free Survival
KW - Neoplasm Staging
KW - Antineoplastic Agents/administration & dosage/adverse effects/therapeutic use
KW - Benzenesulfonates/administration & dosage/adverse effects/therapeutic use
KW - Carcinoma, Renal Cell/drug therapy
KW - Compassionate Use Trials
KW - Kidney Neoplasms/drug therapy
KW - Pyridines/administration & dosage/adverse effects/therapeutic use
U2 - 10.1093/annonc/mdq651
DO - 10.1093/annonc/mdq651
M3 - SCORING: Journal article
C2 - 21324953
VL - 22
SP - 1812
EP - 1823
JO - ANN ONCOL
JF - ANN ONCOL
SN - 0923-7534
IS - 8
M1 - 8
ER -
