Related Experiment Videos
Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial
Tim Eisen1, Stéphane Oudard, Cezary Szczylik
1The Royal Marsden Hospital NHS Trust, Sutton, Surrey, UK. tgqe2@cam.ac.uk
Background:
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 underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy. It is not known how older patients respond to targeted therapy.
Methods:
This retrospective subgroup analysis of data from the phase 3, randomized Treatment Approach in Renal Cancer Global Evaluation Trial examined the safety and efficacy of sorafenib in older (age >or=70 years, n = 115) and younger patients (age <70 years, n = 787) who received treatment for advanced renal cell carcinoma. Patient demographics and progression-free survival were recorded. Best tumor response, clinical benefit rate (defined as complete response plus partial response plus stable disease), time to self-reported health status deterioration, and toxic effects were assessed by descriptive statistics. Health-related quality of life was assessed with a Cox proportional hazards model. Kaplan-Meier analyses were used to summarize time-to-event data.
Results:
Median progression-free survival was similar in sorafenib-treated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69). Clinical benefit rates among younger and older sorafenib-treated patients were also similar (83.5% and 84.3%, respectively) and were superior to those of younger and older placebo-treated patients (53.8% and 62.2%, respectively). Adverse events were predictable and manageable regardless of age. Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients (121 days with sorafenib vs 85 days with placebo; HR = 0.66, 95% CI = 0.43 to 1.03) and younger patients (90 days with sorafenib vs 52 days with placebo; HR = 0.69, 95% CI = 0.59 to 0.81) and improved quality of life over that time.
Conclusions:
Among patients with advanced renal cell carcinoma receiving sorafenib treatment, outcomes of older (>or=70 years) and younger (<70 years) patients were similar.
Insights
Older and younger patients with advanced renal cell carcinoma experienced similar outcomes with sorafenib treatment. This targeted therapy demonstrated comparable efficacy and manageable safety profiles across age groups, improving quality of life for all.
Area of Science:
- Oncology
- Geriatric Medicine
- Pharmacology
Background:
- Older cancer patients are often perceived to be at higher risk for toxic effects and less likely to benefit from cancer therapy.
- This perception may stem from underrepresentation in clinical trials and known toxicities of traditional chemotherapy.
- The response of older adults to novel targeted therapies like sorafenib remains less understood.
Purpose of the Study:
- To evaluate the safety and efficacy of sorafenib in older (>=70 years) versus younger (<70 years) patients with advanced renal cell carcinoma.
- To compare progression-free survival, clinical benefit rates, and health-related quality of life between age groups.
Main Methods:
- Retrospective subgroup analysis of a phase 3 randomized trial (Treatment Approach in Renal Cancer Global Evaluation Trial).
- Compared safety and efficacy data of 115 older patients and 787 younger patients treated with sorafenib.
- Assessed progression-free survival, tumor response, clinical benefit rate, time to health status deterioration, and adverse events.
Main Results:
- Median progression-free survival was similar for older (26.3 weeks) and younger (23.9 weeks) patients receiving sorafenib.
- Clinical benefit rates were comparable between older (84.3%) and younger (83.5%) sorafenib-treated patients, and superior to placebo.
- Adverse events were manageable, and sorafenib delayed health status deterioration and improved quality of life in both age groups.
Conclusions:
- Older patients (>=70 years) and younger patients (<70 years) with advanced renal cell carcinoma exhibit similar outcomes when treated with sorafenib.
- Sorafenib offers a comparable safety and efficacy profile across different age groups for this patient population.
- These findings support the use of targeted therapy in older adults with advanced renal cell carcinoma.
Related Concept Videos
01:18Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Excretion
01:22Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Absorption
01:11Renal Failure: Dose Adjustments
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
02:56Treatment Resistent Cancers
01:00Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Distribution
01:28Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration