Lead Investigator: Lena Friberg, Uppsala University
Title of Proposal Research: Evaluation of dose individualization strategies in optimizing survival and patient-reported outcomes of sunitinib treatment in patients with metastatic renal cell carcinoma
Vivli Data Request: 8807
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Renal cell carcinoma (RCC) is a type of cancer that affects the kidney. According to Global Cancer Observatory (GLOBOCAN) data, in 2020, over 400,000 new cases of RCC were diagnosed, and around 180,000 people died from the disease. People with metastatic RCC (mRCC, when tumor has spread to other parts of their body) used to have a low chance of surviving for 5 years of 7.3% (during 1992-1995), but now, thanks to new medicines, the survival rate has improved to around 14% (during 2011-2017).
Sunitinib is a drug that has been approved for treating mRCC for more than 15 years. It is currently the most cost-effective initial (first-line) treatment for this type of cancer. However, how sunitinib is processed by the body can vary greatly among different patients, and we do not fully understand why. In a study of 60 mRCC patients taking a fixed dose of 50mg of sunitinib every day, the amount of the drug found in their blood plasma varied widely, ranging from 24.5 to 209.4 nanograms per milliliter. This big variability in blood concentration is problematic, since studies have shown that patients with lower levels of sunitinib in their blood may have a lower chance of responding to the treatment and thus lower chance of survival, and that giving them a higher dose may help. However, if the dose is too high, it can cause serious side effects that not only make the treatment less effective but also lower the patient’s quality of life.
Doctors and researchers have been looking into ways to personalize the dose of sunitinib for patients with mRCC instead of giving the same dose to everyone. But there isn’t much clear evidence on how to do this yet, and there aren’t many guidelines or tools to help making these personalized dosing decisions. Therefore, this study aims to gather and analyse patient level data collected across different previously conducted clinical trials to see if there are certain factors, such as the amount of sunitinib in plasma or other indicators in the blood (biomarkers), that can help predict how well a patient will respond to sunitinib treatment.
In this study, we want to explore the inclusion of the perspective and experiences of patients as an important factor when evaluating predictors of treatment outcomes, alongside side effects reported by doctors and survival. Patient-reported outcomes (PROs) are data collected from patients about how they feel during treatment, such as improvement in symptoms related to the disease, any side effects they experience that is hard to tolerate, and their quality of life. By looking at patient level data that includes information about how much of the drug is in their system, any changes in their biomarkers, and their PROs over time, we hope to better understand how we can personalize sunitinib treatment to fit the needs and experiences of each mRCC patient.
Requested Studies:
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Data Contributor: Pfizer Inc.
Study ID: NCT00083889
Sponsor ID: A6181034
A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
Data Contributor: Pfizer Inc.
Study ID: NCT00338884
Sponsor ID: A6181110
Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
Data Contributor: Pfizer Inc.
Study ID: NCT00254540
Sponsor ID: A6181072
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
Data Contributor: Pfizer Inc.
Study ID: NCT00267748
Sponsor ID: A6181065
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Data Contributor: Pfizer Inc.
Study ID: NCT00137423
Sponsor ID: A6181061