Older and younger patients with renal cancer derive similar benefit from sorafenib therapy and tolerate the drug equally well, according to a new study.
Although the risk of being diagnosed with cancer increases with age, relatively few older patients participate in clinical trials. There is a general perception that older patients derive less benefit from therapy and are more likely to suffer side effects than younger patients, despite increasing evidence that there is little or no difference between these patients groups as long as the older patients have good organ function.
To learn how older patients respond to sorafenib, a drug that was approved in 2005 by the FDA for the treatment of renal cancer, Tim Eisen, Ph.D., of Addenbrooke's Hospital and the University of Cambridge, UK, and colleagues performed a retrospective subset analysis on data from a randomized phase III trial that tested sorafenib versus placebo. The TARGET (Treatment Approach in Renal Cancer Global Evaluation Trial) enrolled 115 patients with renal cancer who were 70 years of age or older and 787 who were 69 years of age or younger. Eisen and colleagues compared the two patient groups with respect to clinical benefit, side effects reported, and self-reported time to health status deterioration.
All three measures were similar for the older and younger patient groups. Median progression-free survival was 23.9 weeks for the sorafenib-treated younger patients and 26.3 weeks for the older patients. The percentage of sorafenib-treated older patients who had a complete response, partial response, or stable disease was 84.3 percent compared with 83.5 percent for the younger patients. There were no unexpected adverse events and those that occurred were manageable regardless of age. Finally, sorafenib treatment delayed the time to self-reported health deterioration and improved quality of life over that time for both age groups.
"In this retrospective subgroup analysis of TARGET data, sorafenib treatment appeared to improve outcomes among patients with advanced renal cell carcinoma, regardless of age," the authors write. "Additionally, side effects were expected, mild, and medically manageable. There was no notable difference in the frequency or severity of sorafenib-related toxicity between younger and older patients."
- Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, et al. Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial. J Natl Cancer Inst, October 2008, 100: 1454
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