Safety and efficacy of sorafenib in elderly patients treated in the North American advanced renal cell carcinoma sorafenib expanded access program

Ronald M. Bukowski, Walter M. Stadler, David F. McDermott, Janice P. Dutcher, Jennifer J. Knox, Wilson H. Miller, John D. Hainsworth, Charles A. Henderson, 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, Robert A. Figlin

    Research output: Contribution to journalArticle

    39 Scopus citations

    Abstract

    Objective: In this retrospective analysis of the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program in North America, we compared the safety and efficacy of sorafenib in patients aged ≥70 with those aged <70 years. Methods: Patients were treated with oral sorafenib twice daily until the occurrence of disease progression or treatment intolerance. The primary objective of the ARCCS program was making sorafenib available to patients with advanced renal cell carcinoma (RCC) in the USA and Canada before marketing approval was obtained; the secondary objective was the evaluation of its safety and efficacy. Results: Of the 2,504 patients enrolled in the ARCCS program who received at least 1 dose of sorafenib, 736 (29%) were aged ≥70 years. The most common grade ≥3 adverse events included rash/desquamation (5% in both groups), hand-foot skin reaction (8% in those aged ≥70 years vs. 10% in those <70 years of age), hypertension (5 vs. 4%) and fatigue (7 vs. 4%). Partial response was seen in 4% of the patients in both age groups. The median overall survival for the ≥70-year versus <70-year groups was also similar (46 vs. 50 weeks). Conclusions: There were no substantial differences in safety and efficacy between patients aged ≥70 and <70 years with advanced RCC treated with sorafenib.

    Original languageEnglish (US)
    Pages (from-to)340-347
    Number of pages8
    JournalOncology
    Volume78
    Issue number5-6
    DOIs
    StatePublished - Sep 2010

    Keywords

    • Elderly
    • Metastasis
    • Protein kinase inhibitor
    • Renal cell carcinoma
    • Sorafenib

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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    Bukowski, R. M., Stadler, W. M., McDermott, D. F., Dutcher, J. P., Knox, J. J., Miller, W. H., Hainsworth, J. D., Henderson, C. A., Hajdenberg, J., Kindwall-Keller, T. L., Ernstoff, M. S., Drabkin, H. A., Curti, B. D., Chu, L., Ryan, C. W., Hotte, S. J., Xia, C., Cupit, L., & Figlin, R. A. (2010). Safety and efficacy of sorafenib in elderly patients treated in the North American advanced renal cell carcinoma sorafenib expanded access program. Oncology, 78(5-6), 340-347. https://doi.org/10.1159/000320223