# Sarcopenia and Treatment Tolerability in Older Patients with Advanced Cancer

> **NIH NIH U01** · UNIVERSITY OF ROCHESTER · 2020 · $149,990

## Abstract

Project Summary:
This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-
20-036. The overarching goal of this one-year supplement grant proposal is: to evaluate whether sarcopenia
is associated with tolerability of treatment for advanced cancer in older patients with age-related
conditions. The growing population of older patients remains underrepresented in research that sets cancer
care standards leading to significant disparities in outcomes. In our preliminary research, we found that: 1)
close to 60% of older patients develop grade 3-5 toxicity (as measured by NCI's clinician-rated Common
Terminology Criteria for Adverse Events [CR-CTCAE]); impairment in geriatric assessment (GA) domains were
significantly associated with toxicity; 2) 29% of older adults with cancer received chemotherapy at significantly
reduced relative dose intensity (RDI); and 3) sarcopenia is highly prevalent (58%) in the geriatric oncology
population. U01CA233167 funds secondary analyses of a completed clinical trial to understand how toxicities
inform treatment tolerability as part of a NCI U01 tolerability consortium. The operational definition of tolerability
we proposed in the U01 is novel because it includes not only adverse outcomes such as toxicity, but also
patient-reported outcomes (PROs) valued by older patients. Our analyses utilize data from a completed
randomized trial, the GAP study (URCC 13059, clinicaltrials.gov NCT02054741), which evaluated whether
provision of a GA summary to oncologists would improve clinical outcomes in adults aged 70+ with advanced
cancer receiving treatment (i.e., chemotherapy or other drugs with high risk of toxicity). In this U01 supplement
proposal, we will evaluate whether muscle mass (determined by Computed Tomography [CT] scan body
composition analysis) is independently associated with treatment tolerability. Our tolerability endpoints include
not only toxicity, but also dose intensity, survival, and PROs. Only patients in usual care enrolled to GAP will
be included for these analyses (n=369), because many in the intervention group had initial treatment dosages
altered based on the GA summary. We will collaborate with Voronoi Health Analytics to accurately measure
skeletal muscle mass via CT scan body composition analysis: 1) to determine if sarcopenia is associated with
an increased prevalence of grade 3-5 toxicity (CR-CTCAE v4); 2) to determine if sarcopenia is associated with
cancer treatment RDI; and 3) to determine if sarcopenia is associated with mortality. Exploratory aims will
evaluate if change in muscle mass is associated with clinical outcomes and patient-reported adverse events
(as measured by PRO-CTCAE). The team, which includes expertise in clinical trials (Mohile, Mustian, Hezel,
Linehan), sarcopenia (Dunne, Hezel, Linehan, Voronoi Health Analytics), geriatric oncology (Mohile and Loh),
biostatistics and data science (Culakova, Xu), and PRO measurement (Mohi...

## Key facts

- **NIH application ID:** 10164990
- **Project number:** 3U01CA233167-03S1
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Richard F Dunne
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $149,990
- **Award type:** 3
- **Project period:** 2018-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10164990

## Citation

> US National Institutes of Health, RePORTER application 10164990, Sarcopenia and Treatment Tolerability in Older Patients with Advanced Cancer (3U01CA233167-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10164990. Licensed CC0.

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