Comprehensive Quality of Life Report From a Prospective Clinical Trial of 4DCT-Ventilation Functional Lung Avoidance Radiation Therapy
International Journal of Radiation Oncology, Biology, Physics
Purpose/Objective(s): Functional imaging has been developed that uses 4DCT images and image processing to generate lung ventilation maps (4DCT-ventilation). 4DCT-ventilation functional avoidance uses 4DCT images to generate plans that avoid functional regions of the lung with the goal of reducing pulmonary toxicity. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed, and patient reported outcomes (PRO) measured. PROs are an essential measure of quality-of-life following radiotherapy. The purpose of this work is to quantify PRO changes for lung cancer patients treated with functional avoidance and to compare PROs against clinical pneumonitis. Materials/Methods: Patients with locally advanced lung cancer receiving curative intent radiotherapy (prescriptions of 45-75 Gy) and chemotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data. Favorable arc geometry and optimization techniques were used to generate functional avoidance plans. PRO instruments included the Functional Assessment of Cancer Therapy Lung (FACT-L) questionnaire and the Visual Analog Scale (VAS) administered pre-treatment and 3-, 6-, and 12-months post-treatment to gather data on physical, social, emotional, functional, and pulmonary well-being. The percentage of patients with clinically significant decline was calculated using the FACT-TOI (Trial Outcome Index), FACT-LCS (Lung Cancer Subscale), and VAS instruments. To evaluate the correlation between PROs and clinical toxicity, the percentage of clinically significant FACT-LCS decline was compared (Chisquare test) for patients who did or did not experience grade 2+ pneumonitis. Results: Fifty-nine patients completed baseline PRO surveys. Median age was 65, 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. Clinically significant FACT-TOI decline at, 3, 6, and 12 months was 46.3%, 38.5%, and 26.8%, respectively. The percentage of patients with clinically significant FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3 months, 6 months, and 12 months, respectively. The percentage of patients with clinically significant VAS decline at 3, 6, and 12 months was 18.9%, 20.0%, and 18.6%, respectively. Patients who experienced grade 2+ pneumonitis had a greater percentage of clinically significant decline at all time-points with the results reaching significance (p = 0.045) at 6 months. Conclusion: The study presents the first comprehensive evaluation of PROs for patients treated with 4DCT-ventilation functional avoidance. The data show that 20-40% of patients had clinically significant decline and that PROs had a strong correlation with pneumonitis. The PRO data demonstrate that functional avoidance results in low rates of patient reported outcome clinical decline and provide seminal results to be used in phase III studies.
Lombardo J, Castillo E, Castillo R, Miller RC, Jones BL, Miften M, et al. [Grills IS]. Comprehensive quality of life report from a prospective clinical trial of 4DCT-ventilation functional lung avoidance radiation therapy. Int J Radiat Oncol Biol Phys. 2023 Oct;117(2 Suppl.):S67-S68. doi:10.1016/j.ijrobp.2023.06.372