Journal article
A Phase 2 Randomized Clinical Trial Evaluating 4DCT Ventilation-based Functional Lung Avoidance Radiotherapy for Non-Small Cell Lung Cancer
International journal of radiation oncology, biology, physics, Vol.119(5), pp.1393-1402
02/20/2024
DOI: 10.1016/j.ijrobp.2024.02.019
PMID: 38387810
Abstract
To determine whether 4-dimensional computed tomography (4DCT) ventilation-based functional lung avoidance radiotherapy preserves pulmonary function compared with standard radiotherapy for non-small cell lung cancer (NSCLC).
This single center, randomized, phase 2 trial enrolled patients with NSCLC receiving curative intent radiotherapy with either stereotactic body radiotherapy or conventionally fractionated radiotherapy between 2016 and 2022. Patients were randomized 1:1 to standard of care radiotherapy or functional lung avoidance radiotherapy. The primary endpoint was the change in Jacobian-based ventilation as measured on 4DCT from baseline to three months post-radiation. Secondary endpoints included changes in volume of high- and low-ventilating lung, pulmonary toxicity, and changes in pulmonary function tests (PFTs).
A total of 122 patients were randomized and 116 were available for analysis. Median follow up was 29.9 months. Functional avoidance plans significantly (P<.05) reduced dose to high-functioning lung without compromising target coverage or organs at risk constraints. When analyzing all patients, there was no difference in the amount of lung showing a reduction in ventilation from baseline to 3 months between the two arms (1.91% vs 1.87%; P=.90). Overall grade ≥2 and grade ≥3 pulmonary toxicities for all patients were 24.1% and 8.6%, respectively. There was no significant difference in pulmonary toxicity or changes in PFTs between the two study arms. In the conventionally fractionated cohort, there was a lower rate of grade ≥2 pneumonitis (8.2% vs 32.3%; P=.049) and less of a decline in change in FEV
(-3 vs -5; P=.042) and FVC (1.5 vs -6; P=.005) at 3 months, favoring the functional avoidance arm.
There was no difference in post-treatment ventilation as measured by 4DCT between the arms. In the cohort of patients treated with conventionally fractionated radiotherapy with functional lung avoidance, there was reduced pulmonary toxicity, and less decline in PFTs suggesting a clinical benefit in patients with locally advanced NSCLC.
ClinicalTrials.gov Identifier: NCTXXXX Anonymized for Review XXXX.
Details
- Title: Subtitle
- A Phase 2 Randomized Clinical Trial Evaluating 4DCT Ventilation-based Functional Lung Avoidance Radiotherapy for Non-Small Cell Lung Cancer
- Creators
- Andrew M Baschnagel - UW Health University HospitalMattison J Flakus - University of Wisconsin–MadisonEric M Wallat - University of Wisconsin–MadisonAntonia E Wuschner - University of Wisconsin–MadisonRichard J Chappell - University of Wisconsin–MadisonR Adam Bayliss - UW Health University HospitalRandall J Kimple - UW Health University HospitalGary E ChristensenJoseph M Reinhardt - University of IowaMichael F Bassetti - UW Health University HospitalJohn E Bayouth - Oregon Health & Science University
- Resource Type
- Journal article
- Publication Details
- International journal of radiation oncology, biology, physics, Vol.119(5), pp.1393-1402
- DOI
- 10.1016/j.ijrobp.2024.02.019
- PMID
- 38387810
- eISSN
- 1879-355X
- Grant note
- DOI: 10.13039/100000002, name: National Institutes of Health, award: R01 CA 166703; DOI: 10.13039/100007923, name: University of Wisconsin Carbone Cancer Center, award: P30 CA014520
- Language
- English
- Electronic publication date
- 02/20/2024
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Radiology; Electrical and Computer Engineering; Radiation Oncology; Radiation Research Laboratory; The Iowa Institute for Biomedical Imaging; Advanced Pulmonary Physiomic Imaging Laboratory; Holden Comprehensive Cancer Center
- Record Identifier
- 9984560489502771
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