Primary Results of Ph II NRG-RTOG1106/ECOG-ACRIN 6697 Trial of Individualized Adaptive (chemo)RT Using Midtreatment [18F]FDG PET/CT in Stage III NSCLC

鈥� An ASCO Reading Room selection

January 20, 2025

Feng-Ming (Spring) Kong, MD, PhD, Chen Hu, PhD, Daniel A. Pryma, MD, Fenghai Duan, PhD, Martha Matuszak, PhD, Ying Xiao, PhD, Randall Ten Haken, PhD, Marilyn J. Siegel, MD, Lucy Hanna, MS, MAT, Walter J. Curran, MD, Mark Dunphy, DO, Daphna Gelblum, MD, Morand Piert, MD, Shruti Jolly, MD, Clifford G. Robinson, MD, Andrew Quon, MD, Billy W. Loo, MD, PhD, Shyam Srinivas, MD, PhD, Gregory M. Videtic, MD, Sergio L. Faria, MD, PhD, Catherine Ferguson, MD, Neal E. Dunlap, MD, Vijayananda Kundapur, MD, Rebecca Paulus, BS, Barry A. Siegel, MD, Jeffrey D. Bradley, MD, and Mitchell Machtay, MD

Journal of Clinical Oncology

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Purpose

NRG-RTOG0617 demonstrated a detrimental effect of uniform high-dose radiation in stage III non–small cell lung cancer. NRG-RTOG1106/ECOG-ACRIN6697 (ClinicalTrials.gov identifier: ), a randomized phase II trial, studied whether midtreatment ¹⁸F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) can guide individualized/adaptive dose-intensified radiotherapy (RT) to improve and predict outcomes in patients with this disease.

Materials and Methods

Patients fit for concurrent chemoradiation were randomly assigned (1:2) to standard (60 Gy/30 fractions) or FDG-PET–guided adaptive treatment, stratified by substage, primary tumor size, and histology. All patients had midtreatment FDG-PET/CT; adaptive arm patients had an individualized, intensified boost RT dose to residual metabolically active areas. The primary therapeutic end point was 2-year centrally reviewed freedom from local-regional progression (FFLP), defined as no progression in or near the planning target volume and/or regional nodes. FFLP was analyzed on a modified intent-to-treat population at a one-sided Z-test significance level of 0.15. The primary imaging end point was centrally reviewed change in SUV_peak from baseline to midtreatment; its association with FFLP was assessed using the two-sided Wald test on the basis of Cox regression.

Results

Of 138 patients enrolled, 127 were eligible. Adaptive-arm patients received a mean 71 Gy in 30 fractions, with mean lung dose 17.9 Gy. There was no significant difference in centrally reviewed 2-year FFLP (59.5% and 54.6% in standard and adaptive arms; P=0.66). There were no significant differences in protocol-specified grade 3 toxicities, survival, or progression-free survival (P>0.4). Median SUV_peak and metabolic tumor volume (MTV) in the adaptive arm decreased 49% and 54%, from pre-RT to mid-RT PET. However, ΔSUVpeak and ΔMTV were not associated with FFLP (hazard ratios 0.997, P=0.395 and 0.461).

Conclusion

Midtreatment PET-adapted RT dose escalation as given in this study was safe and feasible but did not improve efficacy outcomes.

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Primary Results of Ph II NRG-RTOG1106/ECOG-ACRIN 6697 Trial of Individualized Adaptive (chemo)RT Using Midtreatment [18F]FDG PET/CT in Stage III NSCLC

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Journal of Clinical Oncology

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