Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non–Small-Cell Lung Cancer

Author:

Bradley Jeffrey D.1,Hu Chen23,Komaki Ritsuko R.4,Masters Gregory A.5,Blumenschein George R.4,Schild Steven E.6,Bogart Jeffrey A.7,Forster Kenneth M.8,Magliocco Anthony M.9,Kavadi Vivek S.10,Narayan Samir11,Iyengar Puneeth12,Robinson Clifford G.13,Wynn Raymond B.14,Koprowski Christopher D.15,Olson Michael R.16,Meng Joanne17,Paulus Rebecca2,Curran Walter J.18,Choy Hak12

Affiliation:

1. Emory University School of Medicine, Atlanta, GA

2. NRG Oncology Statistics and Data Management Center, Pittsburgh, PA

3. Johns Hopkins University School of Medicine, Baltimore, MD

4. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX

5. Medical Oncology Hematology Consultants, PA, Newark, DE

6. Mayo Clinic, Phoenix, AZ

7. State University of New York, Syracuse, NY

8. Geisinger Medical Center, Danville, PA

9. Moffitt Cancer Center, Tampa, FL

10. Texas Oncology-Sugar Land, Sugar Land, TX

11. Saint Joseph Mercy Hospital, Ann Arbor, MI

12. The University of Texas Southwestern Medical Center, Dallas, TX

13. Washington University School of Medicine, St Louis, MO

14. UPMC Shadyside Hospital, Pittsburgh, PA

15. Christiana Care Health Community Clinical Oncology Program, Newark, DE

16. Baptist MD Anderson Cancer Center, Jacksonville, FL

17. Ottawa Hospital and Cancer Center, Ottawa, Ontario, Canada

18. Emory University, Atlanta, GA

Abstract

PURPOSE RTOG 0617 compared standard-dose (SD; 60 Gy) versus high-dose (HD; 74 Gy) radiation with concurrent chemotherapy and determined the efficacy of cetuximab for stage III non–small-cell lung cancer (NSCLC). METHODS The study used a 2 × 2 factorial design with radiation dose as 1 factor and cetuximab as the other, with a primary end point of overall survival (OS). RESULTS Median follow-up was 5.1 years. There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm. Treatment-related grade ≥3 dysphagia and esophagitis occurred in 3.2% and 5.0% of patients in the SD arm v 12.1% and 17.4% in the HD arm, respectively ( P = .0005 and < .0001). There was no difference in pulmonary toxicity, with grade ≥3 AEs in 20.6% and 19.3%. Median OS was 28.7 v 20.3 months ( P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P = .055), respectively. Factors associated with improved OS on multivariable analysis were standard radiation dose, tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5. The use of cetuximab conferred no survival benefit at the expense of increased toxicity. The prior signal of benefit in patients with higher H scores was no longer apparent. The progression rate within 1 month of treatment completion in the SD arm was 4.6%. For comparison purposes, the resultant 2-year OS and PFS rates allowing for that dropout rate were 59.6% and 30.7%, respectively, in the SD arms. CONCLUSION A 60-Gy radiation dose with concurrent chemotherapy should remain the standard of care, with the OS rate being among the highest reported in the literature for stage III NSCLC. Cetuximab had no effect on OS. The 2-year OS rates in the control arm are similar to the PACIFIC trial.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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