DOI: 10.25934/pr00012454
title: Health related-quality of life (HRQoL) and defining immune related adverse events (irAE) in patients with renal cell carcinoma (RCC) offered adjuvant immune checkpoint inhibitor (ICI)

description:  Kidney cancer, or renal cell carcinoma (RCC), is a type of cancer that starts in the kidneys, the organs responsible for filtering waste from your blood and producing urine. When cancer develops in the kidneys, abnormal cells begin to grow uncontrollably, forming a tumor. If not treated, the cancer can spread to other parts of the body. A phase III clinical trial called KEYNOTE-564 showed that a new type of treatment called immune checkpoint inhibitors (ICIs) can reduce the risk of this cancer recurring after curative surgery, ultaimtely improving patient's long term survival. ICIs are a form of therapy that boosts the body’s natural defense system, the immune system, helping it recognize and attack cancer cells. This treatment is becoming more common for kidney cancer patients, but it has raised new questions about how to best measure its benefits and side effects.

As this treatment becomes more widely used, there is a need for better tools to assess how it affects patients' quality of life (HRQoL), or how patients feel during and after treatment. It's also important to more accurately define the side effects (toxicity) that patients may experience. Understanding the patient's quality of life during treatment is crucial for determining whether the benefits of the therapy outweigh its side effects.

Traditionally, quality of life has been measured using tools like questionnaires, which ask patients about their symptoms and how they’re feeling. However, some of the most commonly used tools were designed for patients with more advanced kidney cancer or for patients receiving older treatments, and may not be suitable for those who have had surgery to remove their cancer and are now receiving adjuvant therapy. Adjuvant therapy refers to additional treatment given after the main treatment, like surgery, to help kill any remaining cancer cells and reduce the chance of the cancer coming back. In the case of kidney cancer, patients might receive ICI therapy after surgery as an adjuvant treatment.

Some of the questions in these surveys, such as asking about symptoms like nausea or blood in the urine, may not apply to patients in this particular stage of treatment. New research is underway to create a more relevant quality of life tool for patients who have had surgery and are now undergoing adjuvant treatment for kidney cancer.

Defining the side effects of cancer treatments is essential for managing patient care and ensuring the safety of new drugs. Current methods for measuring side effects may not capture the unique ways in which patients react to immune-based therapies. Some side effects are overestimated, while others might be missed entirely. For example, a side effect might be considered very serious when it has little impact on a patient's overall health, or the long-term effects of a side effect might be overlooked. A new system has been developed that classifies side effects into three categories: life-changing, significant, and non-significant, based on their impact on the patient’s health. These side effects are also categorized by whether they are short-term or long-term.

This research aims to test and confirm these new tools for measuring both quality of life and side effects using data from the IMmotion010 trial. By doing this, we hope to better understand how patients experience treatment and whether those who face more serious side effects from adjuvant ICI also experience a decline in their quality of life.