Z S Zumsteg, M Luu, C Fortpied, J K Jang, M M Chen, J Mallen-St Clair, E Walgama, Q T Le, M Machtay, S Tribius, A Forastiere, S Wong, E Mahmut Ozsahin, V Gregoire, J B Vermorken, A S Ho, S S Yom
{"title":"重新审视头颈癌术后放化疗：RTOG 9501/EORTC 22931的最新长期联合分析","authors":"Z S Zumsteg, M Luu, C Fortpied, J K Jang, M M Chen, J Mallen-St Clair, E Walgama, Q T Le, M Machtay, S Tribius, A Forastiere, S Wong, E Mahmut Ozsahin, V Gregoire, J B Vermorken, A S Ho, S S Yom","doi":"10.1016/j.annonc.2025.07.004","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Post-operative chemoradiation (CRT) is generally recommended for patients with extranodal extension (ENE) and/or positive margins, but not for patients without these features, based on a post-hoc analysis of RTOG 9501 and EORTC 22931. However, this analysis lacked tests of interaction necessary to identify a predictive biomarker. In addition, updated data is now available.</p><p><strong>Patients: </strong>This study assessed 744 patients enrolled on RTOG 9501 and EORTC 22931, randomized trials comparing CRT to RT following surgery. Overall survival (OS) was analyzed with Cox regression. Cancer-specific mortality (CSM), other-cause mortality (OCM), and recurrence outcomes were analyzed with competing risk methodology. Tests of interaction assessed for differential benefits of CRT in various subgroups.</p><p><strong>Results: </strong>Median follow-up was 6.9 years. Among all patients, CRT improved OS (HR=0.81, 95% CI: 0.68-0.97, P=0.026). Although CRT improved OS in the subgroup with ENE and/or positive margins (HR=0.71, 95% CI: 0.57-0.89, P=0.003) and not in those without these features (HR=0.94, 95% CI: 0.68-1.30, P=0.7), tests of interaction showed no evidence of a differential effect of CRT in these subgroups (P-interaction=0.17). There was also no evidence of interaction when analyzing other outcomes, or when assessing ENE and margin status individually. While CRT significantly reduced CSM (HR=0.68, 95% CI: 0.55-0.83, P<0.001), it also significantly increased OCM (HR=1.51, 95% CI: 1.07-2.12, P =0.018). PO-CRT improved locoregional recurrence (HR=0.64, 95% CI: 0.48-0.85, P=0.002), but not distant metastasis (HR=0.83, 95% CI=0.64-1.08, P=0.17).</p><p><strong>Conclusions: </strong>Concurrent chemotherapy improved OS in HNC patients undergoing post-operative radiotherapy in the combined populations of EORTC 22931 and RTOG 9501. ENE and/or positive margins are not predictive biomarkers, and patients without these features may still benefit from CRT. CRT improved CSM, but this was partly offset by higher OCM. Refining the population most likely to benefit from post-operative CRT, taking into consideration both oncologic and patient-related factors, needs further exploration.</p><p><strong>Trial registration: </strong>NRG Oncology's RTOG 9501 (https://clinicaltrials.gov/study/NCT00002670) and EORTC 22931 (https://clinicaltrials.gov/study/NCT00002555).</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7000,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Re-examining Post-operative Chemoradiotherapy in Head and Neck Cancer: An Updated Long-Term Combined Analysis of RTOG 9501/EORTC 22931.\",\"authors\":\"Z S Zumsteg, M Luu, C Fortpied, J K Jang, M M Chen, J Mallen-St Clair, E Walgama, Q T Le, M Machtay, S Tribius, A Forastiere, S Wong, E Mahmut Ozsahin, V Gregoire, J B Vermorken, A S Ho, S S Yom\",\"doi\":\"10.1016/j.annonc.2025.07.004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Post-operative chemoradiation (CRT) is generally recommended for patients with extranodal extension (ENE) and/or positive margins, but not for patients without these features, based on a post-hoc analysis of RTOG 9501 and EORTC 22931. However, this analysis lacked tests of interaction necessary to identify a predictive biomarker. In addition, updated data is now available.</p><p><strong>Patients: </strong>This study assessed 744 patients enrolled on RTOG 9501 and EORTC 22931, randomized trials comparing CRT to RT following surgery. Overall survival (OS) was analyzed with Cox regression. Cancer-specific mortality (CSM), other-cause mortality (OCM), and recurrence outcomes were analyzed with competing risk methodology. Tests of interaction assessed for differential benefits of CRT in various subgroups.</p><p><strong>Results: </strong>Median follow-up was 6.9 years. Among all patients, CRT improved OS (HR=0.81, 95% CI: 0.68-0.97, P=0.026). Although CRT improved OS in the subgroup with ENE and/or positive margins (HR=0.71, 95% CI: 0.57-0.89, P=0.003) and not in those without these features (HR=0.94, 95% CI: 0.68-1.30, P=0.7), tests of interaction showed no evidence of a differential effect of CRT in these subgroups (P-interaction=0.17). There was also no evidence of interaction when analyzing other outcomes, or when assessing ENE and margin status individually. While CRT significantly reduced CSM (HR=0.68, 95% CI: 0.55-0.83, P<0.001), it also significantly increased OCM (HR=1.51, 95% CI: 1.07-2.12, P =0.018). PO-CRT improved locoregional recurrence (HR=0.64, 95% CI: 0.48-0.85, P=0.002), but not distant metastasis (HR=0.83, 95% CI=0.64-1.08, P=0.17).</p><p><strong>Conclusions: </strong>Concurrent chemotherapy improved OS in HNC patients undergoing post-operative radiotherapy in the combined populations of EORTC 22931 and RTOG 9501. ENE and/or positive margins are not predictive biomarkers, and patients without these features may still benefit from CRT. CRT improved CSM, but this was partly offset by higher OCM. Refining the population most likely to benefit from post-operative CRT, taking into consideration both oncologic and patient-related factors, needs further exploration.</p><p><strong>Trial registration: </strong>NRG Oncology's RTOG 9501 (https://clinicaltrials.gov/study/NCT00002670) and EORTC 22931 (https://clinicaltrials.gov/study/NCT00002555).</p>\",\"PeriodicalId\":8000,\"journal\":{\"name\":\"Annals of Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":56.7000,\"publicationDate\":\"2025-07-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.annonc.2025.07.004\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.annonc.2025.07.004","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Re-examining Post-operative Chemoradiotherapy in Head and Neck Cancer: An Updated Long-Term Combined Analysis of RTOG 9501/EORTC 22931.
Background: Post-operative chemoradiation (CRT) is generally recommended for patients with extranodal extension (ENE) and/or positive margins, but not for patients without these features, based on a post-hoc analysis of RTOG 9501 and EORTC 22931. However, this analysis lacked tests of interaction necessary to identify a predictive biomarker. In addition, updated data is now available.
Patients: This study assessed 744 patients enrolled on RTOG 9501 and EORTC 22931, randomized trials comparing CRT to RT following surgery. Overall survival (OS) was analyzed with Cox regression. Cancer-specific mortality (CSM), other-cause mortality (OCM), and recurrence outcomes were analyzed with competing risk methodology. Tests of interaction assessed for differential benefits of CRT in various subgroups.
Results: Median follow-up was 6.9 years. Among all patients, CRT improved OS (HR=0.81, 95% CI: 0.68-0.97, P=0.026). Although CRT improved OS in the subgroup with ENE and/or positive margins (HR=0.71, 95% CI: 0.57-0.89, P=0.003) and not in those without these features (HR=0.94, 95% CI: 0.68-1.30, P=0.7), tests of interaction showed no evidence of a differential effect of CRT in these subgroups (P-interaction=0.17). There was also no evidence of interaction when analyzing other outcomes, or when assessing ENE and margin status individually. While CRT significantly reduced CSM (HR=0.68, 95% CI: 0.55-0.83, P<0.001), it also significantly increased OCM (HR=1.51, 95% CI: 1.07-2.12, P =0.018). PO-CRT improved locoregional recurrence (HR=0.64, 95% CI: 0.48-0.85, P=0.002), but not distant metastasis (HR=0.83, 95% CI=0.64-1.08, P=0.17).
Conclusions: Concurrent chemotherapy improved OS in HNC patients undergoing post-operative radiotherapy in the combined populations of EORTC 22931 and RTOG 9501. ENE and/or positive margins are not predictive biomarkers, and patients without these features may still benefit from CRT. CRT improved CSM, but this was partly offset by higher OCM. Refining the population most likely to benefit from post-operative CRT, taking into consideration both oncologic and patient-related factors, needs further exploration.
期刊介绍：
Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine.
The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings.
Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.
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