Feng-Ming Spring Kong, Chen Hu, Daniel A Pryma, Fenghai Duan, Martha Matuszak, Ying Xiao, Randall Ten Haken, Marilyn J Siegel, Lucy Hanna, Walter J Curran, Mark Dunphy, Daphna Gelblum, Morand Piert, Shruti Jolly, Clifford G Robinson, Andrew Quon, Billy W Loo, Shyam Srinivas, Gregory M Videtic, Sergio L Faria, Catherine Ferguson, Neal E Dunlap, Vijayananda Kundapur, Rebecca Paulus, Barry A Siegel, Jeffrey D Bradley, Mitchell Machtay
{"title":"NRG-RTOG1106/ECOG-ACRIN 6697 的初步结果：在 III 期非小细胞肺癌中使用治疗中期 18F 氟脱氧葡萄糖定位发射断层扫描/计算机断层扫描进行个体化适应性（化疗）放疗的随机 II 期试验。","authors":"Feng-Ming Spring Kong, Chen Hu, Daniel A Pryma, Fenghai Duan, Martha Matuszak, Ying Xiao, Randall Ten Haken, Marilyn J Siegel, Lucy Hanna, Walter J Curran, Mark Dunphy, Daphna Gelblum, Morand Piert, Shruti Jolly, Clifford G Robinson, Andrew Quon, Billy W Loo, Shyam Srinivas, Gregory M Videtic, Sergio L Faria, Catherine Ferguson, Neal E Dunlap, Vijayananda Kundapur, Rebecca Paulus, Barry A Siegel, Jeffrey D Bradley, Mitchell Machtay","doi":"10.1200/JCO.24.00022","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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: NCT01507428), a randomized phase II trial, studied whether midtreatment <sup>18</sup>F-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.</p><p><strong>Materials and methods: </strong>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 <i>Z</i>-test significance level of 0.15. The primary imaging end point was centrally reviewed change in SUV<sub>peak</sub> from baseline to midtreatment; its association with FFLP was assessed using the two-sided Wald test on the basis of Cox regression.</p><p><strong>Results: </strong>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; <i>P</i> = .66). There were no significant differences in protocol-specified grade 3 toxicities, survival, or progression-free survival (<i>P</i> > .4). Median SUV<sub>peak</sub> and metabolic tumor volume (MTV) in the adaptive arm decreased 49% and 54%, from pre-RT to mid-RT PET. However, ΔSUV<sub>peak</sub> and ΔMTV were not associated with FFLP (hazard ratios, 0.997; <i>P</i> = .395 and .461).</p><p><strong>Conclusion: </strong>Midtreatment PET-adapted RT dose escalation as given in this study was safe and feasible but did not improve efficacy outcomes.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3935-3946"},"PeriodicalIF":42.1000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Primary Results of NRG-RTOG1106/ECOG-ACRIN 6697: A Randomized Phase II Trial of Individualized Adaptive (chemo)Radiotherapy Using Midtreatment <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Stage III Non-Small Cell Lung Cancer.\",\"authors\":\"Feng-Ming Spring Kong, Chen Hu, Daniel A Pryma, Fenghai Duan, Martha Matuszak, Ying Xiao, Randall Ten Haken, Marilyn J Siegel, Lucy Hanna, Walter J Curran, Mark Dunphy, Daphna Gelblum, Morand Piert, Shruti Jolly, Clifford G Robinson, Andrew Quon, Billy W Loo, Shyam Srinivas, Gregory M Videtic, Sergio L Faria, Catherine Ferguson, Neal E Dunlap, Vijayananda Kundapur, Rebecca Paulus, Barry A Siegel, Jeffrey D Bradley, Mitchell Machtay\",\"doi\":\"10.1200/JCO.24.00022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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: NCT01507428), a randomized phase II trial, studied whether midtreatment <sup>18</sup>F-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.</p><p><strong>Materials and methods: </strong>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 <i>Z</i>-test significance level of 0.15. The primary imaging end point was centrally reviewed change in SUV<sub>peak</sub> from baseline to midtreatment; its association with FFLP was assessed using the two-sided Wald test on the basis of Cox regression.</p><p><strong>Results: </strong>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; <i>P</i> = .66). There were no significant differences in protocol-specified grade 3 toxicities, survival, or progression-free survival (<i>P</i> > .4). Median SUV<sub>peak</sub> and metabolic tumor volume (MTV) in the adaptive arm decreased 49% and 54%, from pre-RT to mid-RT PET. However, ΔSUV<sub>peak</sub> and ΔMTV were not associated with FFLP (hazard ratios, 0.997; <i>P</i> = .395 and .461).</p><p><strong>Conclusion: </strong>Midtreatment PET-adapted RT dose escalation as given in this study was safe and feasible but did not improve efficacy outcomes.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"3935-3946\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO.24.00022\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO.24.00022","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/4 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Primary Results of NRG-RTOG1106/ECOG-ACRIN 6697: A Randomized Phase II Trial of Individualized Adaptive (chemo)Radiotherapy Using Midtreatment 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Stage III Non-Small Cell Lung Cancer.
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: NCT01507428), 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 SUVpeak 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 = .66). There were no significant differences in protocol-specified grade 3 toxicities, survival, or progression-free survival (P > .4). Median SUVpeak 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 = .395 and .461).
Conclusion: Midtreatment PET-adapted RT dose escalation as given in this study was safe and feasible but did not improve efficacy outcomes.
期刊介绍：
The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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