BERKELEY, CA (UroToday.com) - Although a high percentage of the patient population referred to oncology departments is elderly, access to trials of pivotal drugs is typically restricted for patients aged 65 and above.
On the contrary, this population setting should be evaluated carefully owing to the increased fragility, the frequent presence of comorbidities, and the increased risk of adverse events.
Commonly, the inclusion criteria in clinical trials encourage the enrolment of younger patients. While the benefit and tolerability of drugs are evaluated on this younger population setting, the regulatory agencies transfer hypothetical drug benefit to the whole patient population.
When we consider renal cell carcinoma, the median age of diagnosis is 65 years old. Concerning the six drugs currently approved for the treatment of kidney cancer, only a few elderly patients are enrolled in phase III registration studies.
At the present time, sorafenib, as well as being the first drug to demonstrate efficacy in renal cell carcinoma, is a drug that has been evaluated in a larger number of elderly patients.
The vast quantity of data gathered respect to sorafenib demonstrates that elderly patients are able to tolerate the drug as successfully as younger patients. On the contrary, a preplanned subgroup analysis of the phase III trial disclosed a lower efficacy of temsirolimus in elderly patients with respect to IFN-alpha. An hypothesis is that this issue could be related to the kind of adverse events associated wth the mTOR inhibitor.
The post-hoc sub-analysis of the pivotal placebo-controlled phase III trial (TARGET study) on 115 patients ≥70 years old showed that, as is the case with younger patients, sorafenib significantly increases PFS without compromising quality of life.
Moreover, a retrospective post-hoc subset analysis of the North American expanded access study, which estimated the safety and the efficacy of sorafenib in more than 700 elderly patients (≥70 years), showed outcomes fully comparable to those observed in younger patients.
Similarly, the sub-analysis undertaken on 265 elderly patients (≥70 years) treated in the European expanded access study revealed a PFS similar to younger patients, and a survival rate comparable to the one observed in the whole population of the TARGET study. Finally, recent data concerning 530 patients≥70 years treated with sorafenib in a third expanded access study reported an efficacy, in terms of PFS, similar to that of younger patients. On the whole, an overall analysis carried out on 4600 patients with RCC treated with sorafenib reported that the safety profile observed in patients >75 years old is similar to that in younger ones.
In conclusion, clinical experience with other targeted agents for the treatment of RCC in elderly patients is limited. With the aim of optimizing therapeutic benefits for elderly patients with renal cell carcinoma, it is important to consider the age and the presence of comorbidities. Sorafenib efficacy in the elderly suggests that the incidence of adverse events associated with this therapy is similar in elderly patients to that of a younger population and may also be considered a safe and efficacious treatment option in elderly patients with comorbidities.
Giuseppe Procopio, MD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.