Can Muscle Health Predict Outcomes in Clinical Trials for Oncology?

The ancient Greeks depicted an ideal form and physique known as the “Grecian ideal” featuring chiseled, seemingly perfect muscles that we see in so many of the sculptures of the sixth century. Achieving this ideal had the benefit of intimidating enemies and producing a dashing appearance. Now science is revealing that muscle health can also be a predictor of patient outcomes in cancer treatment.

Low muscle mass (also termed sarcopenia) and poor muscle quality (myosteatosis) are prevalent and independent predictors of poor patient outcomes in cancer. “Contrary to what one may think, low muscle mass isn’t unique to cancer cachexia and should be assessed in all oncologic patients regardless of weight status, cancer type or stage of disease,” says Catarina Ribeiro, MD, MSc, MBA Medical Director, Hematology Oncology Clinical Solutions at Syneos Health.

Despite the growing evidence on the clinical impact of body composition, most clinical trials in oncology are not assessing it nor exploring its impact on drug tolerability and efficacy, noted Ribeiro and team. “It is in the drug developer’s best interest to ensure that the optimal dose is determined during a phase I trial and further assessed in later phases, with the best dose being at the intersection of good tolerability (e.g., safety assessed by adverse events) and efficacy (e.g., cancer control/survival outcomes). Adjusting therapy dosage based on body composition should be explored to achieve optimal treatment regimens.”

What does assessing body composition mean for cancer treatment? Ribeiro answers:

• A patient’s body composition may provide a better understanding of factors accounting for the variability seen between patients in terms of toxicity and response to treatments
• Patients who express or lack certain biomarkers have improved or reduced response to treatment. Quantifying a patient’s body composition can help us tailor anti-cancer treatments for better outcomes and improve patient safety and quality of life
• Dosing of systemic therapies in oncology on patients without accounting for skeletal muscle mass can potentially be a physiological reason why a patient would suffer more toxicities
• The impact of body composition variability on clinical outcomes could explain a portion of failure seen in select phase I clinical trials
• If trial patients have lower muscle mass compared to the target population, could result in lower efficacy than a dose optimized for a patient’s body composition or vice versa

In the oncologic setting, assessing skeletal muscle mass is surprisingly easy, convenient, and inexpensive. Like all paradigm changes, implementing a solution requires awareness and time. To enable better and faster access to life-changing innovation for oncology patients, it’s up to each of us to drive change by spreading and applying this knowledge. What will you do to contribute to innovation in contemporary clinical trials?

Download the white paper below to explore how muscle weakness can be used as an indicator for better outcomes in clinical trials.

Contributors

Catarina Ribeiro, MD, MSc, MBA Medical Director Hematology Oncology Clinical Solutions, Syneos Health

Katherine Ford, MSc, RD Dept of Agricultural, Food & Nutritional Science, University of Alberta

Carla Prado, PhD, RD Dept of Agricultural, Food & Nutritional Science, University of Alberta

To download the free whitepaper, fill out the form below:

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