Yoon-Koo Kang, Min-Hee Ryu, Do-Youn Oh, Sang Cheul Oh, Sun Young Rha, Keun-Wook Lee, Ik Joo Chung, Sung Yong Oh, Sun Jin Sym, Won Ki Kang, Jong Gwang Kim, Byoung Yong Shim, In-Ho Kim, Jin Young Kim, Eun-Kee Song, Hyo-Jin Lee, Seok Yun Kang, Dong-Hoe Koo, So Yeon Oh
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Patients received nivolumab or placebo, both combined with physician-choice chemotherapy (oxaliplatin plus oral S-1 [tegafur‒gimeracil‒oteracil] [SOX] or oral capecitabine [CAPOX]).</p><p><strong>Results: </strong>Overall, 464 patients were initially screened in Korea and 291 were randomized to nivolumab + chemotherapy (total/SOX/CAPOX: 148/66/82 patients) or placebo + chemotherapy (total/SOX/CAPOX: 143/61/82 patients). Centrally assessed progression-free survival (median: 14.75 vs. 8.34 months; hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.39‒0.73, p<0.0001), overall survival (19.7 vs. 14.9 months; HR 0.78; 95% CI 0.60‒1.02, p=0.0651), overall response rate (54.7% vs. 47.6%), and duration of response (16.03 vs. 9.86 months) favored nivolumab + chemotherapy vs. placebo + chemotherapy. Grade ≥3 treatment-related adverse events (TRAEs) (56.1% vs. 44.1%), and any-grade endocrine (9.5% vs. 4.2%), hepatic (23.0% vs. 14.7%), hypersensitivity and infusion reactions (15.5% vs. 7.0%), renal (4.1% vs. 0.7%), and skin (44.6% vs. 23.1%) TRAEs tended to be more frequent in the nivolumab + chemotherapy group.</p><p><strong>Conclusion: </strong>These findings demonstrate the clinical benefit of nivolumab combined with chemotherapy (either SOX or CAPOX) for first-line treatment of gastric cancer/gastroesophageal junction cancer in Korean patients.</p>","PeriodicalId":49094,"journal":{"name":"Cancer Research and Treatment","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nivolumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Korean Patients with HER2-Negative, Untreated, Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer: Subgroup Analysis of a Randomized, Multicenter, Double-Blind Phase 3 Trial (ATTRACTION-4).\",\"authors\":\"Yoon-Koo Kang, Min-Hee Ryu, Do-Youn Oh, Sang Cheul Oh, Sun Young Rha, Keun-Wook Lee, Ik Joo Chung, Sung Yong Oh, Sun Jin Sym, Won Ki Kang, Jong Gwang Kim, Byoung Yong Shim, In-Ho Kim, Jin Young Kim, Eun-Kee Song, Hyo-Jin Lee, Seok Yun Kang, Dong-Hoe Koo, So Yeon Oh\",\"doi\":\"10.4143/crt.2024.913\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>We report the safety and efficacy of nivolumab + chemotherapy for first-line treatment of advanced or recurrent gastric or gastroesophageal junction cancer in the Korean subpopulation of the ATTRACTION-4 clinical trial.</p><p><strong>Materials and methods: </strong>ATTRACTION-4 (NCT02746796) was a double-blind, randomized, placebo-controlled clinical trial of patients aged ≥20 years with histologically confirmed unresectable advanced or recurrent gastric or gastroesophageal junction cancer. Patients received nivolumab or placebo, both combined with physician-choice chemotherapy (oxaliplatin plus oral S-1 [tegafur‒gimeracil‒oteracil] [SOX] or oral capecitabine [CAPOX]).</p><p><strong>Results: </strong>Overall, 464 patients were initially screened in Korea and 291 were randomized to nivolumab + chemotherapy (total/SOX/CAPOX: 148/66/82 patients) or placebo + chemotherapy (total/SOX/CAPOX: 143/61/82 patients). Centrally assessed progression-free survival (median: 14.75 vs. 8.34 months; hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.39‒0.73, p<0.0001), overall survival (19.7 vs. 14.9 months; HR 0.78; 95% CI 0.60‒1.02, p=0.0651), overall response rate (54.7% vs. 47.6%), and duration of response (16.03 vs. 9.86 months) favored nivolumab + chemotherapy vs. placebo + chemotherapy. Grade ≥3 treatment-related adverse events (TRAEs) (56.1% vs. 44.1%), and any-grade endocrine (9.5% vs. 4.2%), hepatic (23.0% vs. 14.7%), hypersensitivity and infusion reactions (15.5% vs. 7.0%), renal (4.1% vs. 0.7%), and skin (44.6% vs. 23.1%) TRAEs tended to be more frequent in the nivolumab + chemotherapy group.</p><p><strong>Conclusion: </strong>These findings demonstrate the clinical benefit of nivolumab combined with chemotherapy (either SOX or CAPOX) for first-line treatment of gastric cancer/gastroesophageal junction cancer in Korean patients.</p>\",\"PeriodicalId\":49094,\"journal\":{\"name\":\"Cancer Research and Treatment\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2025-07-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Research and Treatment\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4143/crt.2024.913\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Research and Treatment","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4143/crt.2024.913","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：我们报道在ATTRACTION-4临床试验的韩国亚群中，nivolumab +化疗一线治疗晚期或复发性胃癌或胃食管结癌的安全性和有效性。材料和方法：ATTRACTION-4 （NCT02746796）是一项双盲、随机、安慰剂对照的临床试验，研究对象为年龄≥20岁、组织学证实不可切除的晚期或复发胃癌或胃食管结癌患者。患者接受纳武单抗或安慰剂治疗，两者均联合医生选择的化疗（奥沙利铂+口服S-1[替加福-吉美拉西-奥特拉西][SOX]或口服卡培他滨[CAPOX]）。结果：总体而言，在韩国最初筛选了464例患者，其中291例随机分为纳武单抗+化疗组（total/SOX/CAPOX: 148/66/82例）或安慰剂+化疗组（total/SOX/CAPOX: 143/61/82例）。中央评估的无进展生存期(中位数：14.75 vs 8.34个月；风险比[HR] 0.53；结论：这些发现证明了nivolumab联合化疗（SOX或CAPOX）一线治疗韩国胃癌/胃食管结癌患者的临床获益。
Nivolumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Korean Patients with HER2-Negative, Untreated, Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer: Subgroup Analysis of a Randomized, Multicenter, Double-Blind Phase 3 Trial (ATTRACTION-4).
Purpose: We report the safety and efficacy of nivolumab + chemotherapy for first-line treatment of advanced or recurrent gastric or gastroesophageal junction cancer in the Korean subpopulation of the ATTRACTION-4 clinical trial.
Materials and methods: ATTRACTION-4 (NCT02746796) was a double-blind, randomized, placebo-controlled clinical trial of patients aged ≥20 years with histologically confirmed unresectable advanced or recurrent gastric or gastroesophageal junction cancer. Patients received nivolumab or placebo, both combined with physician-choice chemotherapy (oxaliplatin plus oral S-1 [tegafur‒gimeracil‒oteracil] [SOX] or oral capecitabine [CAPOX]).
Results: Overall, 464 patients were initially screened in Korea and 291 were randomized to nivolumab + chemotherapy (total/SOX/CAPOX: 148/66/82 patients) or placebo + chemotherapy (total/SOX/CAPOX: 143/61/82 patients). Centrally assessed progression-free survival (median: 14.75 vs. 8.34 months; hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.39‒0.73, p<0.0001), overall survival (19.7 vs. 14.9 months; HR 0.78; 95% CI 0.60‒1.02, p=0.0651), overall response rate (54.7% vs. 47.6%), and duration of response (16.03 vs. 9.86 months) favored nivolumab + chemotherapy vs. placebo + chemotherapy. Grade ≥3 treatment-related adverse events (TRAEs) (56.1% vs. 44.1%), and any-grade endocrine (9.5% vs. 4.2%), hepatic (23.0% vs. 14.7%), hypersensitivity and infusion reactions (15.5% vs. 7.0%), renal (4.1% vs. 0.7%), and skin (44.6% vs. 23.1%) TRAEs tended to be more frequent in the nivolumab + chemotherapy group.
Conclusion: These findings demonstrate the clinical benefit of nivolumab combined with chemotherapy (either SOX or CAPOX) for first-line treatment of gastric cancer/gastroesophageal junction cancer in Korean patients.
期刊介绍：
Cancer Research and Treatment is a peer-reviewed open access publication of the Korean Cancer Association. It is published quarterly, one volume per year. Abbreviated title is Cancer Res Treat. It accepts manuscripts relevant to experimental and clinical cancer research. Subjects include carcinogenesis, tumor biology, molecular oncology, cancer genetics, tumor immunology, epidemiology, predictive markers and cancer prevention, pathology, cancer diagnosis, screening and therapies including chemotherapy, surgery, radiation therapy, immunotherapy, gene therapy, multimodality treatment and palliative care.
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