NEW YORK (Reuters Health) – New research suggests that older patients with advanced renal cell carcinoma glean as much benefit from sorafenib as do their younger counterparts. Moreover, the side effects seen with the drug were predictable and manageable, regardless of patient age.

In a retrospective study of participants in the phase III Treatment Approach in Renal Cancer Global Evaluation Trial (TARGET), the rate of clinical benefit, defined as a complete response, partial response, or stable disease, was roughly 85% in both younger and older patients. With placebo, the rate of clinical benefits did not exceed 62.2%.

“The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the under-representation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy,” lead author Dr. Tim Eisen and colleagues write.

Exactly how older patients would respond to a molecularly targeted therapy, like sorafenib, was unclear, according to the report in the Journal of the National Cancer Institute for October 15.

Dr. Eisen, from Addenbrooke’s Hospital in Cambridge, UK, and colleagues compared the safety and efficacy of sorafenib in 787 patients who were 69 years or younger and 115 who were 70 years or older.

Compared with placebo, treatment with sorafenib reduced the risk of disease progression by 45% in younger patients and by 57% in older patients (p = NS). The median progressive-free survival periods were 23.9 and 26.3 weeks in younger and older patients, respectively.

Older and younger patients treated with sorafenib experienced similar delays in self-reports of health deterioration, both of which were better than seen with placebo. Lastly, sorafenib therapy was associated with improvements in quality of life.

“Although exploratory in nature, this subgroup analysis of the pivotal TARGET trial demonstrated that sorafenib conferred a statistically significant increase in progression-free survival and increased clinical benefit without compromising the quality of life of both older and younger patients with advanced renal carcinoma,” the researchers conclude.

Sorafenib was approved by the U.S. Food and Drug Administration in 2005 to treat advanced renal cell carcinoma.

Reference:
J Natl Cancer Inst 2008;100:1-10.