Tim Eisen, MD, senior lecturer, medical oncology division, Royal Marsden Hospital NHS Trust, Sutton, United Kingdom, and colleagues assessed the effect of age on clinical outcomes and tolerability with sorafenib treatment.

"While the incidence of renal-cell carcinoma increases dramatically with age, older patients are often under-represented in oncology trials and inherently perceived [as being] at higher risk of toxicity with less than optimal outcomes," Dr. Eisen pointed out in his presentation on September 30^th.

The analysis used data from a phase 3 trial of sorafenib that enrolled 903 patients. Of 451 sorafenib-treated patients, 305 were less than 65 years of age, and 146 patients were 65 years of age or older. No differences were noted in baseline demographics or co-morbidities for sorafenib-treated patients across age subgroups versus placebo.

Clinical benefit was observed in about 85% of patients receiving sorafenib in the subgroups under 65 years of age and 65 years of age or older.

Sorafenib consistently resulted in a 2-fold improvement in median progression-free survival (PFS) versus placebo. Regardless of age, PFS benefit with sorafenib was consistent by patient subgroups.

No difference was observed in adverse-effect profiles of sorafenib by age.

By the fifth cycle, most of the sorafenib-treated patients reported "stable" or "better" symptom response than placebo.

At weeks 18 and 24, more sorafenib-treated patients had stable or improved total scores in Functional Assessment of Cancer Therapy-Kidney Symptom Index from baseline compared with placebo.

Overall, the results show that sorafenib demonstrated similar clinical benefit and a low toxicity profile irrespective of age, Dr. Eisen noted.

The study was sponsored by Bayer Pharmaceuticals.


[Presentation title: Clinical Benefit of Sorafenib in the Elderly With Advanced Renal Cell Carcinoma: Subgroup Analysis of the Approaches in Renal Cancer Global Evaluation Trial (TARGETS). Abstract Number 446PD]

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