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

被引：425

作者：

Bradley, Jeffrey D. ^{[1
]}

Hu, Chen ^{[2
,3
]}

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, Samir ^{[11
]}

Iyengar, Puneeth ^{[12
]}

Robinson, Clifford G. ^{[13
]}

Wynn, Raymond B. ^{[14
]}

Koprowski, Christopher D. ^{[15
]}

Olson, Michael R. ^{[16
]}

Meng, Joanne ^{[17
]}

Paulus, Rebecca ^{[2
]}

Curran, Walter J., Jr. ^{[18
]}

Choy, Hak ^{[12
]}

机构：

[1] Emory Univ, Sch Med, Atlanta, GA 30322 USA

[2] NRG Oncol Stat & Data Management Ctr, Pittsburgh, PA USA

[3] Johns Hopkins Univ, Sch Med, Baltimore, MD USA

[4] Univ Texas MD Anderson Canc Ctr, Dept Thorac Head & Neck Med Oncol, Houston, TX 77030 USA

[5] Med Oncol Hematol Consultants, Newark, DE USA

[6] Mayo Clin, Phoenix, AZ USA

[7] SUNY Syracuse, Syracuse, NY USA

[8] Geisinger Med Ctr, Danville, PA 17822 USA

[9] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA

[10] Texas Oncol Sugar Land, Sugar Land, TX USA

[11] St Joseph Mercy Hosp, Ann Arbor, MI 48104 USA

[12] Univ Texas Southwestern Med Ctr Dallas, Dallas, TX 75390 USA

[13] Washington Univ, Sch Med, St Louis, MO 63110 USA

[14] UPMC, Shadyside Hosp, Pittsburgh, PA USA

[15] Christiana Care Hlth Community Clin Oncol Program, Newark, DE USA

[16] Baptist MD Anderson Canc Ctr, Jacksonville, FL USA

[17] Ottawa Hosp & Canc Ctr, Ottawa, ON, Canada

[18] Emory Univ, Atlanta, GA 30322 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2020年 / 38卷 / 07期

关键词：

CLINICAL-TRIALS; RADIOTHERAPY;

D O I：

10.1200/JCO.19.01162

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOS ERTOG 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. (C) 2019 by American Society of Clinical Oncology

引用

页码：706 / +

页数：10

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