{"title":"高危胃癌 D2 切除术后化放疗与化疗的长期预后分析:一项前瞻性随机对照研究的结果","authors":"","doi":"10.1016/j.ijrobp.2024.07.072","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.</div></div><div><h3>Results</h3><div>The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; <em>P</em> = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; <em>P</em> = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; <em>P</em> = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; <em>P</em> < 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (<em>P</em> < 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; <em>P</em> = 0.08), but the difference was not significant.</div></div><div><h3>Conclusion</h3><div>The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-Term Prognostic Analysis of Chemoradiotherapy vs. Chemotherapy after D2 Resection for High-Risk Gastric Cancer: Results from a Prospective Randomized Control Study\",\"authors\":\"\",\"doi\":\"10.1016/j.ijrobp.2024.07.072\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose/Objective(s)</h3><div>To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.</div></div><div><h3>Results</h3><div>The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; <em>P</em> = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; <em>P</em> = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; <em>P</em> = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; <em>P</em> < 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (<em>P</em> < 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; <em>P</em> = 0.08), but the difference was not significant.</div></div><div><h3>Conclusion</h3><div>The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.</div></div>\",\"PeriodicalId\":14215,\"journal\":{\"name\":\"International Journal of Radiation Oncology Biology Physics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Radiation Oncology Biology Physics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0360301624008344\",\"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":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0360301624008344","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
材料/方法这项随机临床试验在2011年10月1日至2019年12月31日期间招募了患者。接受D2胃切除术的病理确诊胃癌患者(任何T期,N+,M0)被随机(1:1)分配接受术后化放疗(CRT)或辅助化疗。辅助化疗组的干预措施为8个周期的SOX(S-1+奥沙利铂)化疗。放疗在4-6个周期的SOX化疗后进行。在S-1化疗的同时,采用调强放射治疗(IMRT)技术,在5周内进行25次1.8 Gy的分次放疗,每次45 Gy。主要终点是3年无病生存期(DFS)。急性毒性反应根据《不良事件通用术语标准》4.0版进行评估和分级。结果由于患者入组缓慢,该试验于2022年6月结束。共有308名患者(中位数[IQR]年龄,58[23-74]岁;221[71.8%]名男性和87[28.8%]名女性)入组,其中157名患者被随机分配到辅助化疗组,151名患者被随机分配到辅助化放疗组。121名患者(46.5%)为III期患者。对照组的三年 DFS 为 67.2%,实验组为 67.5%(危险比 [HR] = 1.08;95% CI = 0.69-1.70;P = 0.74)。在总生存率(HR = 0.81;95% CI = 0.49-1.33;P = 0.40)或局部复发率(HR = 1.58;95% CI = 0.66-3.82;P = 0.31)方面,组间无明显差异。在对患者淋巴结阳性数目和淋巴结转移位置进行分析后,我们将pN分期≥N2且有腹膜外淋巴结转移的患者定义为高危组,其余患者定义为低危组。高危组和低危组的三年 DFS 分别为 59.8% 和 76.2%(HR = 2.05; 95% CI = 1.30-3.25; P <0.05)。对于高危患者,辅助化疗组和辅助化放疗组的三年DFS分别为54.0%和71.2%(P <0.05)。辅助化疗组的3级和4级急性毒性反应多于化放疗组(42例[26.8%] vs 18例[17.5%];P = 0.08),但差异不显著。
Long-Term Prognostic Analysis of Chemoradiotherapy vs. Chemotherapy after D2 Resection for High-Risk Gastric Cancer: Results from a Prospective Randomized Control Study
Purpose/Objective(s)
To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.
Materials/Methods
This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
Results
The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; P = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; P = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; P = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; P < 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (P < 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; P = 0.08), but the difference was not significant.
Conclusion
The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.
期刊介绍:
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.