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Comprehensive Patient Reported Outcomes (PROs) from NRG Oncology/Alliance LU005: A Randomized Trial Of Chemoradiation
Benjamin Movsas1, Chen Hu2, Kristin A Higgins3
1Henry Ford Cancer Institute, Detroit, MI.
Purpose:
While NRG-LU005 showed no overall survival (OS) advantage by adding concurrent and adjuvant immunotherapy to chemoRT (CRT), it reported longer OS in an exploratory comparison of twice-daily (BID) over once-daily (QD) radiation (RT). This planned analysis assessed longitudinal PROs. The pre-specified hypothesis was that clinically-meaningful-decline (CMD) in longer term PROs at 15 months would be lower with immunotherapy, as measured by the Functional-Assessment-of-Cancer-Therapy:Trial-Outcome-Index (FACT-TOI).
Methods:
Patients (N=544) were randomized to standard CRT (platinum/etoposide + thoracic-RT [45Gy-BID or 66Gy-QD]) +/- atezolizumab starting cycle-2 of chemotherapy. Stratification factors (SFs) included RT-schedule, chemotherapy-type, sex, and performance-status(PS). PROs included validated instruments: FACT-TOI, EQ-5D-5L, and PROMIS-Fatigue (at baseline, end-of-CRT, and at 3, 6, 15, and 21 months). EQ-5D-5L scores were followed through 24 months. CMD and longitudinal trends were evaluated; multivariable logistic regression analysis (MVA) adjusted for treatment-arm, SFs, and baseline FACT-TOI.
Results:
PRO compliance exceeded 85% at baseline and stabilized at 60-68% through 21 months. CMD in FACT-TOI was not significantly different by treatment arm at 15 months, though fewer patients on the immunotherapy arm had CMD at 21 months. EQ-5D-5L and PROMIS-fatigue were similar in both arms. BID-RT was associated with better FACT-TOI than QD-RT across all timepoints. On MVA, significant predictors of lower CMD for FACT-TOI (beyond baseline FACT-TOI) included BID-RT (at end-of-CRT, 15, 21 months), PS (at end-of-CRT), cisplatin (at 15 months), and immunotherapy (at 21 months).
Conclusions:
The addition of atezolizumab to chemoradiation was not associated with a significant change in CMD in FACT-TOI at 15 months, with similar EQ-5D-5L and fatigue scores. While not randomized for RT-schedule, this analysis suggests that BID-RT (vs QD-RT) was associated with a consistently more favorable PRO trajectory.
