248 SUNITINIB IN PATIENTS (PTS) WITH OR WITHOUT PRIOR NEPHRECTOMY IN AN EXPANDED-ACCESS STUDY OF METASTATIC RENAL CELL CARCINOMA (MRCC)

2009 ◽  
Vol 8 (4) ◽  
pp. 182
Author(s):  
C. Szczylik ◽  
C. Porta ◽  
S. Bracarda ◽  
R. Hawkins ◽  
G.A. Bjarnason ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Expanded Access

Safety and Efficacy of Sunitinib in Patients from Italy with Metastatic Renal Cell Carcinoma: Final Results from an Expanded-Access Trial

Oncology ◽  
2015 ◽  
Vol 88 (5) ◽  
pp. 273-280 ◽  
Author(s):  
Cora N. Sternberg ◽  
Fabio Calabr� ◽  
Sergio Bracarda ◽  
Giacomo Carten� ◽  
Giovanni Lo Re ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Safety And Efficacy ◽  
Expanded Access

scholarly journals Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma

2016 ◽  
Vol Volume 9 ◽  
pp. 5839-5845 ◽  
Author(s):  
Jaya Vas ◽  
Carlos Barrios ◽  
Daniel Herchenhorn ◽  
Matias Chacón ◽  
Paula Cabrera-Galeana ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Latin America ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Safety And Efficacy ◽  
Expanded Access

Everolimus in patients with metastatic renal cell carcinoma refractory to VEGF-targeted therapy: REACT subgroup analysis of prior therapy.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 391-391
Author(s):  
James M. G. Larkin ◽  
Christian U. Blank ◽  
Petri Bono ◽  
Svetozar Gogov ◽  
Ashok Panneerselvam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Kinase Inhibitor ◽  
Prior Treatment ◽  
Serious Adverse Events ◽  
Expanded Access ◽  
Grade 3

391 Background: Efficacy of everolimus (EVE) in metastatic renal cell carcinoma (mRCC) refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapy is well established. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to provide patients with VEGFR-TKI-refractory mRCC access to EVE in advance of regulatory approval. Methods: REACT, an open-label, international, expanded-access clinical trial (Clinicaltrials.gov: NCT00655252 ) enrolled patients with measurable or nonmeasurable mRCC of any histology who were intolerant of, or progressed while on, VEGFR-TKI therapy. Long-term safety of EVE 10 mg/day in patients with mRCC, as determined by overall incidence of grade 3/4 and serious adverse events (AEs) was documented. RECIST-defined tumor response was also assessed by local investigator. Subgroup analyses evaluated effect of prior treatment on safety and efficacy of EVE. Results: Of 1367 patients enrolled, most (92.7%) had progressed on prior VEGFR-TKI therapy, and some (24.4%) were VEGFR-TKI intolerant. Across patient subgroups by prior VEGFR-TKI treatment, median EVE treatment duration was similar (Table). Best overall response rates were similar in the VEGFR-TKI-intolerant subgroup and overall populations: respectively, 1.8% and 1.7% had partial response (PR) while 53.5% and 51.6% had stable disease (SD). Incidence of grade 3/4 AEs across all prior treatment subgroups were similar to those of the overall population. (See table.) Conclusions: Patients enrolled in REACT derived benefit from EVE irrespective of prior VEGFR-TKI therapy, including VEGFR-TKI-intolerant patients. EVE is well tolerated and affords disease stabilization in the majority of patients with VEGFR-TKI-refractory mRCC, and is the standard of care in this patient population. [Table: see text]

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