Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): Results of a Double-Blind, Randomized Controlled Trial
Abstract
PURPOSE
To determine if functional lung avoidance based on 3He MRI improves quality of life (QOL) for patients undergoing chemoradiotherapy (CCRT) for advanced non-small cell lung cancer (NSCLC).
MATERIALS/METHODS
Patients with stage III NSCLC (or oligometastatic disease treated with curative intent) undergoing CCRT with at least a 10 pack-year smoking history were eligible. Patients underwent pre-treatment 3He MRI to measure lung ventilation and had two radiotherapy (RT) plans created before randomization: a standard plan, which did not make use of the 3He MRI, and an avoidance plan, preferentially sparing well-ventilated lung. All participants were blinded except the physicist responsible for exporting the selected plan. The primary endpoint was patient-reported QOL measured at 3-months post-RT by the FACT-L lung cancer subscale (LCS); secondary endpoints included other QOL metrics, toxicity, and survival outcomes. Target accrual was 64.
RESULTS
Twenty-seven patients were randomized before the trial was closed due to slower-than-expected accrual, with 11 randomized to the standard arm and 16 to the avoidance arm. Baseline patient characteristics were well-balanced. At 3 months post-RT, the mean±SD LCS scores were 17.4±2.8 vs. 17.3±6.1 for the standard and avoidance arms, respectively (P=0.485). A clinically meaningful, pre-specified decline of ≥3 points in the LCS score was observed in 50% (4/8) in the standard arm and 33% (4/12) in the avoidance arm (P=0.648). Two…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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