S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk
{"title":"辅助放疗与放化疗在中危早期宫颈癌根治性子宫切除和淋巴结切除术后的随机III期试验：来自NRG Oncology/GOG-263/KGOG1008的结果","authors":"S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk","doi":"10.1016/j.annonc.2025.09.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.</p><p><strong>Methods: </strong>Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m<sup>2</sup> were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).</p><p><strong>Results: </strong>Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB<sub>1</sub> and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.</p><p><strong>Conclusion: </strong>Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008.\",\"authors\":\"S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk\",\"doi\":\"10.1016/j.annonc.2025.09.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.</p><p><strong>Methods: </strong>Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m<sup>2</sup> were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).</p><p><strong>Results: </strong>Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB<sub>1</sub> and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.</p><p><strong>Conclusion: </strong>Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.</p>\",\"PeriodicalId\":8000,\"journal\":{\"name\":\"Annals of Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":65.4000,\"publicationDate\":\"2025-09-12\",\"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.2025.09.003\",\"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.2025.09.003","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008.
Background: To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.
Methods: Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m2 were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).
Results: Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB1 and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.
Conclusion: Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.
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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