PMID- 31841363 OWN - NLM STAT- MEDLINE DCOM- 20201204 LR - 20240328 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 38 IP - 7 DP - 2020 Mar 1 TI - 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. PG - 706-714 LID - 10.1200/JCO.19.01162 [doi] AB - 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 x 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. FAU - Bradley, Jeffrey D AU - Bradley JD AD - Emory University School of Medicine, Atlanta, GA. FAU - Hu, Chen AU - Hu C AD - NRG Oncology Statistics and Data Management Center, Pittsburgh, PA. AD - Johns Hopkins University School of Medicine, Baltimore, MD. FAU - Komaki, Ritsuko R AU - Komaki RR AD - Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Masters, Gregory A AU - Masters GA AD - Medical Oncology Hematology Consultants, PA, Newark, DE. FAU - Blumenschein, George R AU - Blumenschein GR AD - Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Schild, Steven E AU - Schild SE AD - Mayo Clinic, Phoenix, AZ. FAU - Bogart, Jeffrey A AU - Bogart JA AD - State University of New York, Syracuse, NY. FAU - Forster, Kenneth M AU - Forster KM AD - Geisinger Medical Center, Danville, PA. FAU - Magliocco, Anthony M AU - Magliocco AM AD - Moffitt Cancer Center, Tampa, FL. FAU - Kavadi, Vivek S AU - Kavadi VS AD - Texas Oncology-Sugar Land, Sugar Land, TX. FAU - Narayan, Samir AU - Narayan S AD - Saint Joseph Mercy Hospital, Ann Arbor, MI. FAU - Iyengar, Puneeth AU - Iyengar P AD - The University of Texas Southwestern Medical Center, Dallas, TX. FAU - Robinson, Clifford G AU - Robinson CG AD - Washington University School of Medicine, St Louis, MO. FAU - Wynn, Raymond B AU - Wynn RB AD - UPMC Shadyside Hospital, Pittsburgh, PA. FAU - Koprowski, Christopher D AU - Koprowski CD AD - Christiana Care Health Community Clinical Oncology Program, Newark, DE. FAU - Olson, Michael R AU - Olson MR AD - Baptist MD Anderson Cancer Center, Jacksonville, FL. FAU - Meng, Joanne AU - Meng J AD - Ottawa Hospital and Cancer Center, Ottawa, Ontario, Canada. FAU - Paulus, Rebecca AU - Paulus R AD - NRG Oncology Statistics and Data Management Center, Pittsburgh, PA. FAU - Curran, Walter J Jr AU - Curran WJ Jr AD - Emory University, Atlanta, GA. FAU - Choy, Hak AU - Choy H AD - The University of Texas Southwestern Medical Center, Dallas, TX. LA - eng SI - ClinicalTrials.gov/NCT00533949 GR - U10 CA180868/CA/NCI NIH HHS/United States GR - UG1 CA189867/CA/NCI NIH HHS/United States GR - P30 CA016672/CA/NCI NIH HHS/United States GR - UG1 CA233302/CA/NCI NIH HHS/United States GR - U24 CA196067/CA/NCI NIH HHS/United States GR - U24 CA180803/CA/NCI NIH HHS/United States GR - U10 CA180822/CA/NCI NIH HHS/United States GR - UG1 CA233339/CA/NCI NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20191216 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - BG3F62OND5 (Carboplatin) RN - P88XT4IS4D (Paclitaxel) RN - PQX0D8J21J (Cetuximab) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carboplatin/administration & dosage MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology/*radiotherapy MH - Cetuximab/administration & dosage MH - Chemoradiotherapy MH - Dose Fractionation, Radiation MH - Dose-Response Relationship, Radiation MH - Humans MH - Lung Neoplasms/*drug therapy/pathology/*radiotherapy MH - Neoplasm Staging MH - Paclitaxel/administration & dosage MH - Progression-Free Survival MH - Survival Rate PMC - PMC7048161 EDAT- 2019/12/17 06:00 MHDA- 2020/12/15 06:00 PMCR- 2021/03/01 CRDT- 2019/12/17 06:00 PHST- 2019/12/17 06:00 [pubmed] PHST- 2020/12/15 06:00 [medline] PHST- 2019/12/17 06:00 [entrez] PHST- 2021/03/01 00:00 [pmc-release] AID - 1901162 [pii] AID - 10.1200/JCO.19.01162 [doi] PST - ppublish SO - J Clin Oncol. 2020 Mar 1;38(7):706-714. doi: 10.1200/JCO.19.01162. Epub 2019 Dec 16.