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Original Article
- 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)
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Yoon-Koo Kang1
, Min-Hee Ryu1, Do-Youn Oh2, Sang Cheul Oh3, Sun Young Rha4, Keun-Wook Lee5, Ik Joo Chung6, Sung Yong Oh7, Sun Jin Sym8, Won Ki Kang9, Jong Gwang Kim10, Byoung Yong Shim11, In-Ho Kim12, Jin Young Kim13, Eun-Kee Song14, Hyo-Jin Lee15, Seok Yun Kang16, Dong-Hoe Koo17, So Yeon Oh18 -
DOI: https://doi.org/10.4143/crt.2024.913 [Accepted]
Published online: July 2, 2025
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Department of Oncology, Seoul National University Hospital, Seoul, Korea
3Department of Hematology and Oncology, Korea University Guro Hospital, Seoul, Korea
4Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
5Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
6Department of Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea
7Department of Oncology, Dong-A University College of Medicine, Busan, Korea
8Department of Oncology, Gachon University Gil Hospital, Incheon, Korea
9Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
10Department of Oncology, Kyungpook National University Medical Center, Daegu, Korea
11Division of Medical Oncology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
12Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
13Department of Hematology and Oncology, Keimyung University Dongsan Medical Center, Daegu, Korea
14Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea
15Department of Oncology, Chungnam National University Hospital, Daejeon, Korea
16Department of Hematology-Oncology, Ajou University Hospital, Suwon, Korea
17Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
18Department of Oncology, Pusan National University Yangsan Hospital, Yangsan, Korea
2Department of Oncology, Seoul National University Hospital, Seoul, Korea
3Department of Hematology and Oncology, Korea University Guro Hospital, Seoul, Korea
4Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
5Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
6Department of Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea
7Department of Oncology, Dong-A University College of Medicine, Busan, Korea
8Department of Oncology, Gachon University Gil Hospital, Incheon, Korea
9Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
10Department of Oncology, Kyungpook National University Medical Center, Daegu, Korea
11Division of Medical Oncology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
12Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
13Department of Hematology and Oncology, Keimyung University Dongsan Medical Center, Daegu, Korea
14Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea
15Department of Oncology, Chungnam National University Hospital, Daejeon, Korea
16Department of Hematology-Oncology, Ajou University Hospital, Suwon, Korea
17Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
18Department of Oncology, Pusan National University Yangsan Hospital, Yangsan, Korea
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Corresponding author:
Yoon-Koo Kang
Email: ykkang@amc.seoul.kr
Received: 13 September 2024 • Accepted: 1 July 2025
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Abstract
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.
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