Health-related quality of life and quality-adjusted progression

Background Decisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS). Methods HRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum. Results 168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8–5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1–5.9). Conclusions Kd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact.

Standard of Living Definition, How to Measure, Example

Progression-free (PFS) and overall survival (OS) landmark analysis from

Change in FACT‐BMT score between baseline and 1‐year post‐transplant.

Change in FACT‐BMT score between baseline and 1‐year post‐transplant.

PDF) Health literacy as a moderator of health-related quality of life responses to chronic disease among Chinese rural women

Quality of care across health system platforms in low-income and

JPatientRepOutcomes (@JPRO_ISOQOL) / X

Figure A1: The relationship between quality-adjusted life years (QALYs)

Quality-adjusted life year is useful, not discriminatory- STAT

Changes in quality-adjusted life expectancy in Belgium, 2013 and 2018, Archives of Public Health

Evolution of the Ostomy Adjustment System (OAS) in Norway: A Comprehensive Journey from Conception to Implementation and Beyond - Western Norway University of Applied Sciences

PDF) Mapping SF-36 onto the EQ-5D index: How reliable is the relationship?

Example of a choice set used to determine utility weights for the QLU-C10D

Higher order models for the EORTC QLQ-C30 (models 1e7 was taken from