# Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)

> **NIH NIH U01** · DANA-FARBER CANCER INST · 2020 · $618,498

## Abstract

Project Summary
EVOLV proposes to deliver sophisticated and standardized methods for assessing, monitoring, analyzing, and
reporting adverse events (AEs) experienced by individuals undergoing cancer treatment. These methods will
harness the potential of the patient-reported outcomes version of the NCI Common Terminology Criteria for
Adverse Events (PRO-CTCAETM) to provide previously unavailable patient perspectives on the tolerability of
treatments (including targeted agents, immunotherapies, and other evolving treatments for which the type,
severity, timing, and trajectory of adverse events is less known). Such information will help providers better
identify and support patients at risk for treatment discontinuation, dose reductions, and treatment delays.
Specifically, this study aims to: 1) perform longitudinal analyses of CTCAE and PRO-CTCAE data from trials
conducted within the ECOG-ACRIN Cancer Research Group, using traditional and innovative strategies to
examine AE trajectories and to produce a new reporting standard that reflects severity and fluctuations over
time; 2) examine PRO-CTCAE and CTCAE predictors of treatment adherence and discontinuation; and 3)
validate the broader predictive value of GP5, a single item from the Functional Assessment of Cancer Therapy-
General (FACT-G) shown to predict early treatment discontinuation among women with breast cancer taking
aromatase inhibitors. The study will also explore two novel measurement models for PRO-CTCAE scores and
CTCAE grades: a phenotypic model including co-occurrence of symptoms and a cumulative burden index
(CBI) for characterizing the quantity of burden accumulated by patients over time. Analyses will include
demographic factors and insurance status to identify potential disparities.

## Key facts

- **NIH application ID:** 9996547
- **Project number:** 5U01CA233169-03
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** ROBERT J GRAY
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $618,498
- **Award type:** 5
- **Project period:** 2018-09-18 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996547

## Citation

> US National Institutes of Health, RePORTER application 9996547, Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV) (5U01CA233169-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9996547. Licensed CC0.

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