Abstract
The majority of women diagnosed with breast cancer will experience some form of drug-related toxicity and subsequent impairments in Health-related Quality of Life (HRQoL). Despite this, HRQoL is assessed inconsistently and there is no validated method to integrate HRQoL data into the assessment of therapeutic agents. This proof of concept study utilizes data from the neoadjuvant I-SPY 2 clinical trial to describe the development of the Quality of Life Index (QoLI) measure. The QoLI represents a single composite score that incorporates validated longitudinal measures of clinical efficacy and QoL and one that permits a more comprehensive, direct comparison of individual therapeutic agents. Preliminary data suggest the QoLI is able to distinguish between agents based on their efficacy and toxicity; with further validation, the QoLI has the potential to provide more patient-centered evaluations in clinical trials and help guide treatment decision making in breast cancer and other oncologic diseases.
Highlights
Breast cancer remains the most frequently diagnosed cancer among women worldwide, accounting for a quarter of all diagnoses
Drug 3 and 4 both possessed similar distribution and mean values on the residual cancer burden (RCB) index (0.87 vs. 0.85), suggesting similar clinical efficacy (Fig. 1a); examination of the Lost Quality Adjusted Life Years (QALYs) and Quality of Life Index (QoLI) measures suggest that Drug 3 is less toxic and overall better tolerated by patients (Fig. 1b, c)
Our analysis focuses on the 102 patients with complete data rather than conducting imputation, and our data represent a proof of concept study
Summary
Breast cancer remains the most frequently diagnosed cancer among women worldwide, accounting for a quarter of all diagnoses. Despite this growing evidence base, along with various efforts by governing bodies to integrate HRQoL data into the assessment of oncologic agents[8], the utilization of HRQoL or other Patient-Reported Outcome (PRO) measures in clinical trials remains inconsistent.
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