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Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America by Walter M. Stadler; Robert A. Figlin; David F. McDermott; Janice P. Dutcher; Jennifer J. Knox; Wilson H. Miller Jr; John D. Hainsworth; Charles A. Henderson; Jeffrey R. George; Julio Hajdenberg; Tamila L. Kindwall-Keller; Marc S. Ernstoff; Harry A. Drabkin; Brendan D. Curti; Luis Chu; Christopher W. Ryan; Sebastien J. Hotte; Chenghua Xia; Lisa Cupit; Ronald M. Bukowski is a Medicine article available to read on EtoBox.
What is Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America about?
## Abstract ## BACKGROUND: The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program made sorafenib available to patients with advanced renal cell carcinoma (RCC) before regulatory approval. ## METHODS: In this nonrandomized, open‐label expanded access program, 2504 patients from the United States and Canada were treated with oral sorafenib 400 mg twice daily. Safety and efficacy were explored overall and in subgroups of patients including those with no prior therapy, nonclear cell (nonclear cell) RCC, brain metastases, prior bevacizumab treatment, and elderly patients. Sorafenib was approved for RCC 6 months after study initiation, at which time patients with no prior therapy or with nonclear cell RCC could enroll in an extension protocol for continued assessment for a period of 6 months. ## RESULTS: The most common grade ≥2 drug‐related adverse events were hand‐foot skin reaction (18%), rash (14%), hypertension (12%), and fatigue (11%). In the 1891 patients evaluable for response, complete response was observed in 1 patient, partial response in 67 patients (4%), and stable disease for at least 8 weeks in 1511 patients (80%). Median progression‐free survival in the extension pop
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- Author
- Walter M. Stadler; Robert A. Figlin; David F. McDermott; Janice P. Dutcher; Jennifer J. Knox; Wilson H. Miller Jr; John D. Hainsworth; Charles A. Henderson; Jeffrey R. George; Julio Hajdenberg; Tamila L. Kindwall-Keller; Marc S. Ernstoff; Harry A. Drabkin; Brendan D. Curti; Luis Chu; Christopher W. Ryan; Sebastien J. Hotte; Chenghua Xia; Lisa Cupit; Ronald M. Bukowski
- Publisher
- John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0008-543X)
- Published
- 2010
- Language
- EN
- Field
- Medicine (Health Sciences)