Dosing and switching patterns for renal cell carcinoma (RCC) patients receiving selected angiogenesis inhibitor therapies
Authors: M. S. Duh, A. Fournier, E. Moyneur, E. Dial, M. P. Neary, W. K. Oh
Journal: Journal of Clinical Oncology (2008)

5111 Background: Angiogenesis inhibitor therapies, including oral sunitinib, oral sorafenib, and IV bevacizumab (off-label), represent a breakthrough in the treatment (tx) of RCC. This study evaluates dosing and switching pattern patterns for these agents, before and after the approval of sunitinib and sorafenib in 2006. Methods: Pts with ≥ 2 RCC claims (ICD-9 189.0, 198.0) receiving sunitinib (n=305), sorafenib (n=306) or bevacizumab (n=148) were identified from a large US health insurance claims database covering over 39 million people between Jan 02 - Dec 06. Pts were observed from their first tx until the last tx date. Results: Bevacizumab was administered prior to and after 2006. Administration of bevacizumab declined after approval of sunitinib and sorafenib. 67% of IV bevacizumab initiators in 2006 did not receive an oral angiogenesis agent prior to their tx with bevacizumab. Of these bevacizumab pts, over 30% later received other IV therapies, and only 17% later received sunitinib or sorafenib upon discontinuation of bevacizumab. Upon approval of sunitinib and sorafenib, 68% of sunitinib pts and 79% of sorafenib pts received their tx as first-line therapy, while 66% of sunitinib and 32% of sorafenib pts received their tx as 2nd or 3rd line tx. Median doses and tx durations were 50 mg/day and 99 days for sunitinib, 800 mg/day and 91 days for sorafenib and 10 mg/kg/dose and 85 days for bevacizumab. Conclusions: Of RCC pts who received angiogenesis inhibitors, over 60% were for first-line tx. 11% of sunitinib, 23% of sorafenib and 44% of bevacizumab pts changed to another therapy suggesting a need for additional tx options for refractory or intolerant pts. First-line and later line use of IV off-label therapies, occurred even after approved oral agents became available. The median tx durations in real-life settings were approximately half of those reported in the Phase III trials, suggesting early termination potentially due to tx failures, toxicities, or other reasons. Tx History Bevacizumab Sunitinib N=305 Sorafenib N=306 Initiated Before 2006 N=112 Initiated In 2006 N=36 Angiogenesis Inhibitor Therapy Single Drug Only 47 (42%) 16 (44%) 182 (60%) 189 (62%) At Least One Prior Tx 41 (37%) 12 (33%) 99 (32%) 65 (21%) Angiogenesis Inhibitor Therapies - 1 (3%) 76 (25%) 32 (10%) Sunitinib - 0 (0%) - 21 (7%) Sorefanib - 1 (3%) 65 (21%) - Bevacizumab - - 16 (5%) 12 (4%) Interferon 9 (8%) 1 (3%) 19 (6%) 16 (5%) Other IV Tx 27 (24%) 9 (25%) 32 (10%) 28 (9%) Other Oral Tx 16 (14%) 3 (8%) 14 (5%) 11 (4%) At Least One Post Tx 46 (41%) 16 (44%) 33 (11%) 70 (23%) Angiogenesis Inhibitor Therapies 17 (15%) 6 (17%) 23 (8%) 67 (22%) Sunitinib 12 (11%) 4 (11%) - 65 (21%) Sorefanib 11 (10%) 2 (6%) 22 (7%) - Bevacizumab - - 1 (0%) 2 (1%) Interferon 2 (2%) 2 (6%) 1 (0%) 3 (1%) Other IV Tx 25 (22%) 11 (31%) 7 (2%) 5 (2%) Other Oral Tx 11 (10%) 1 (3%) 8 (3%) 4 (1%) Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GlaxoSmithKline GlaxoSmithKline Bayer-Onyx, Genentech, GlaxoSmithKline, Pfizer