A national, multicenter, non-interventional, observational study on treatment patterns in patients with metastatic

Şuayib Yalçın1, Ramazan Yildiz2, Faysal Dane3

  • 1Hacettepe University, Department of Medical Oncology, Ankara, Turkey.

Abstract

Insights

Everolimus offers a safe and effective treatment for metastatic renal cell carcinoma (mRCC) after initial therapies. Real-world data shows improved progression-free and overall survival compared to previous studies.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Research

Background:

  • Targeted therapies, including VEGF and mTOR pathway inhibitors, have improved renal cell carcinoma outcomes.
  • In Turkey, reimbursement policies mandate interferon and VEGF-TKI use before other treatments for metastatic renal cell carcinoma (mRCC).

Purpose of the Study:

  • To evaluate the efficacy and safety of everolimus in Turkish patients with mRCC.
  • To provide real-world data on everolimus use after two prior treatment lines (interferon and VEGF-TKI).

Main Methods:

  • Prospective, non-interventional, observational study involving 100 mRCC patients across 11 centers.
  • Assessed progression-free survival, overall survival, and adverse events associated with everolimus treatment.

Main Results:

  • Median progression-free survival was 8.1 months (95% CI: 5.1-11.1).
  • Median overall survival was 17.6 months (95% CI: 10.1-25.1).
  • Survival outcomes exceeded those reported in the RAD001 Phase III trial.

Conclusions:

  • Everolimus demonstrates a safe and effective treatment option for mRCC in real-world settings.
  • The drug exhibits an acceptable safety and tolerability profile for patients previously treated with VEGF-TKI.

Related Concept Videos

Observational Studies01:11

Observational Studies

Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
11.1K
Serum Studies: Renal Function Tests01:24

Serum Studies: Renal Function Tests

Renal function tests are crucial for assessing kidney health, monitoring disease progression, and evaluating the kidneys' efficiency in waste elimination, fluid balance, and electrolyte regulation. These tests offer critical insights into kidney function, even though routine measurements may appear normal until there is a significant decline in the glomerular filtration rate or GFR. Typically, signs of kidney impairment only become evident when the GFR falls to about 50% of its normal level.
457
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
164
Case Studies01:22

Case Studies

There are many research methods available to psychologists in their efforts to understand, describe, and explain behavior and the cognitive and biological processes that underlie it.
13.7K
National Nursing Organizations I01:26

National Nursing Organizations I

Nursing organizations assume a significant role in consistently developing the nursing profession through education, research studies, establishing practice standards, and reforming health policies. Typically, nursing organizations operate at the regional, national, and international levels. For example, the International Council of Nurses (ICN) represents more than 28 million nurses worldwide. In contrast, the American Nurses Association (ANA) is a membership organization representing nurses...
3.1K
National Nursing Organizations II01:30

National Nursing Organizations II

Nursing organizations play a vital role in representing nurses working in specialized clinical settings, such as the American Association of Critical-Care Nurses (AACN).
The AACN emphasizes a healthy work environment through six standards to achieve an optimal patient outcome. The standards are appropriate staffing, meaningful recognition, collaboration, authentic leadership, effective communication, and decision-making. In addition, AACN provides certification programs, webinars, journals, and...
2.1K