Targeted Therapies; Many elderly patients with metastatic renal cell carcinoma (RCC) who are often under represent in clinical trials to treat the kidney cancer are seeing overall survival benefits from treatment with targeted therapies, according to a new study from Penn Medicine researchers publish this month in JAMA Network Open.
Analyzing 13 years of data on Medicare patients, the study found that the patients who received targeted therapies were more medically complex than those who receive the older, more toxic treatments that were available earlier in the study period, indicating that newer treatments are offering hope to more people.
Since 2005, the U.S. Food and Drug Administration has approve 12 targeted therapies for the treatment of advance RCC. However, clinical trials investigating these therapies often exclude sicker patients; also those over the age of 65, leaving a gap in knowledge about the effectiveness of newer versus older treatments in this population; so especially when they are treat in routine health care settings rather than in research studies.
Our findings suggest that targeted therapies offered new treatment options to elderly and medically complex patients who may have otherwise foregone the treatments available 15 years ago given their high toxicity and limited benefit,” said senior author Jalpa A. Doshi, Ph.D., a professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania.
The researchers conducted a retrospective cohort study using Surveillance, Epidemiology; also End Results (SEER)-Medicare data from 2000 to 2013 to examine overall survival and estimate overall survival improvements in over 1,100 patients with stage IV clear cell RCC who received any FDA-approved targeted therapy (63% of patients) or nontargeted therapy (37% of patients).
World patient population
Despite the findings, the median survival benefits observe in this real world patient population; so were smaller compare to the benefits seen in clinical trial participants enroll in randomized studies of targeted therapies. The combined findings underscore that research studies summarize outcomes for groups of patients; also may not accurately reflect how treatments will perform in the real world or what any individual patient can expect from treatment.
For example, in this study, half of the targeted therapy group had pass away within nine months; but 10% of people survived longer than 47 months. Among that group with better outcomes, targeted therapies offered an 11-month survival advantage over older treatments, the researchers reported. Treatment decisions involve weighing potential risks, benefits, and costs of treatment as well as quality-of-life considerations; which may vary from person to person depending on their medical situation and preferences.
Good communication between patients and their treatment teams is essential, and knowing more about real-world outcomes can help with those discussions,” said co-author Amy R. Pettit, Ph.D., adjunct fellow at the Penn Center for Public Health Initiatives. The study not only demonstrates that an older, more medically complex population has benefit from target therapies; but also highlights the importance of rigorous methods to evaluate the real world impact of treatments; its on health outcomes, the researchers wrote.