Previously, the primary endpoint results of the NRG-LU005 study assessing the addition of the immunotherapy drug atezolizumab to standard of care concurrent chemoradiation for limited-stage small cell lung cancer were reported at the American Society for Radiation Oncology 2024 Annual Meeting. Those results showed that adding atezolizumab did not improve overall survival (OS) for this patient population. At the same time, an exploratory analysis reported longer median OS among patients who received twice-a-day radiation, though the RT schedule was not randomized. As a follow-up to that study, a patient-reported outcomes (PRO) analysis explored the impact of the NRG-LU005 treatment regimens on quality of life (QOL). The results of this PRO analysis were recently reported as a late-breaking abstract at the ASTRO 2025 Annual Meeting in San Francisco, California.
Although NRG-LU005 results did not meet its primary endpoint regarding OS, the study reported that twice daily radiation was associated with better survival than once daily radiation. While this study was not randomized between twice-daily and once-daily radiation, the NRG-LU005 PRO analysis also suggested less clinically meaningful decline in longer-term QOL with twice daily (versus once daily) radiation.
NRG-LU005 accrued 544 evaluable patients and randomized patients receiving standard chemoradiation with thoracic RT (either at 45Gy twice daily or 66Gy daily) to plus/minus concurrent and adjuvant immunotherapy. PROs included validated instruments: FACT-TOI, EQ-5D-5L, and PROMIS-Fatigue. Clinical meaningful decline (CMD) and longitudinal trends were also evaluated.
PRO compliance for this analysis exceeded 85% at baseline and stabilized at 60-68% through 21 months after completion of chemoradiation. Higher completion correlated with better baseline performance status and pulmonary function. FACT-TOI declined on both arms during chemoradiation as expected; however, this improved at 3 months and either remained stable or exceeded the baseline by 6-21 months following treatment. As hypothesized, fewer patients on the immunotherapy arm of NRG-LU005 experienced CMD (25% vs. 38%) in FACT-TOI at 21 months. Of note, while this study was not randomized between twice daily and once daily RT, approximately half of the patients received twice daily radiation, and this was associated with relatively better quality of life (QOL) over time than those receiving once daily radiation in the analysis. This overall benefit in QOL on the twice-daily RT arm was further supported by a multivariable analysis.
“While this study was not randomized between twice-daily versus once-daily radiation, these QOL findings suggest that, relative to once-daily radiation, twice-daily radiation is associated with quality-of-life advantages from the patient perspective,” says Dr. Benjamin Movsas, QOL chair of this NRG LU005 study, as well as Medical Director of Henry Ford Cancer in Michigan
Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), U24CA196067 (NRG Specimen Bank), U24CA180803 (IROC), and CTEP. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Genentech also supported this project.
Source: NRG Oncology
