A Phase 2 Randomized Clinical Trial Evaluating 4-Dimensional Computed Tomography Ventilation-Based Functional Lung...

Area of Science:

• Radiation Oncology
• Pulmonary Medicine
• Medical Imaging

Background:

• Non-small cell lung cancer (NSCLC) treatment often involves radiation therapy, which can lead to pulmonary complications.
• Preserving lung function during radiation is crucial for patient outcomes and quality of life.
• Four-dimensional computed tomography (4DCT) offers functional imaging to guide radiation planning.

Purpose of the Study:

• To evaluate if 4DCT-based functional lung avoidance radiation therapy preserves pulmonary function compared to standard radiation therapy in NSCLC patients.
• To assess changes in lung ventilation, pulmonary toxicity, and pulmonary function tests (PFTs) post-treatment.

Main Methods:

• A single-center, randomized phase 2 trial included NSCLC patients receiving curative intent radiation therapy.
• Patients were randomized to standard radiation therapy or functional lung avoidance radiation therapy.
• Primary endpoint: change in Jacobian-based ventilation on 4DCT from baseline to 3 months post-radiation. Secondary endpoints included pulmonary toxicity and PFT changes.

Main Results:

• Functional avoidance plans reduced radiation dose to high-functioning lung without compromising treatment efficacy.
• No significant difference in overall post-treatment lung ventilation reduction between the two arms.
• In the conventionally fractionated cohort, functional avoidance led to lower rates of grade ≥2 pneumonitis and less decline in FEV1 and FVC at 3 months.

Conclusions:

• 4DCT-based functional lung avoidance radiation therapy did not show a difference in post-treatment ventilation compared to standard therapy.
• A clinical benefit was observed in patients with locally advanced NSCLC treated with conventionally fractionated radiation therapy and functional lung avoidance, indicated by reduced pulmonary toxicity and preserved PFTs.