Evidence map›Paper›PMID 39162872›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2024

Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial.

Narikazu Boku, Takeshi Omori, Kohei Shitara, Shinichi Sakuramoto, Kensei Yamaguchi, Ken Kato, Shigenori Kadowaki, Kunihiro Tsuji, Min-Hee Ryu, Do-Youn Oh and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02746796 (ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer), which is not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02746796 phase2 / phase3completednot on this map

ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer

TypeinterventionalSponsorOno Pharmaceutical Co., Ltd.Ran2016 to 2022Enrolled680ConditionsGastric CancerArmsONO-4538, Oxaliplatin, Tegafur- Gimeracil-Oteracil potassium, Capecitabine, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Narikazu BokuDepartment of Oncology and General Medicine, IMSUT Hospital, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Takeshi OmoriDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Shinichi SakuramotoSaitama Medical University International Medical Center, Hidaka, Japan.
Kensei YamaguchiDepartment of Gastroenterological Chemotherapy, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Ken KatoDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Kunihiro TsujiDepartment of Medical Oncology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Sang Cheul OhDivision of Hematology and Oncology, Department of Internal Medicine, College of Medicine, Korea University, Seoul, South Korea.
Sun Young RhaDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, Songdang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Keun-Wook LeeDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Ik-Joo ChungDepartment of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, South Korea.
Sun Jin SymDivision of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.
Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, and National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Jen-Shi ChenDivision of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Li-Yuan BaiDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, and China Medical University, Taichung, Taiwan.
Takashi NakadaDepartment of Oncology Clinical Development Planning, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Shunsuke HagiharaDepartment of Statistical Analysis, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Reina MakinoDepartment of Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Eiji NishiyamaDepartment of Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul, 05505, South Korea. ykkang@amc.seoul.kr.ORCID 0000-0003-0783-6583

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab + chemotherapy is now a standard of care for HER2-negative, previously untreated, unresectable or recurrent gastric/gastroesophageal junction cancer (advanced gastric cancer), but long-term follow-up data of clinical trials are limited.

methodsATTRACTON-4 was a phase 3, double-blind, placebo-controlled trial in Japan, South Korea, and Taiwan. Patients were randomized to either nivolumab or placebo, both combined with the physician's choice of SOX (oral S-1 [tegafur-gimeracil-oteracil potassium] + oxaliplatin) or CAPOX (capecitabine + oxaliplatin). We report the primary endpoints-centrally assessed progression-free survival (PFS) and overall survival (OS)-and landmark analyses of OS among patients alive using 3-year follow-up data.

resultsAt the cutoff date (May 10, 2021), 17/359 patients in the nivolumab + chemotherapy group and 6/358 in the placebo + chemotherapy group were continuing study treatment. PFS (centrally assessed) was longer in the nivolumab + chemotherapy group (median 10.94 vs. 8.48 months; hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.55-0.82). Although OS did not differ between the two groups (median 17.45 vs. 17.15 months; HR 0.89, 95% CI 0.75-1.05), the landmark analysis of OS, calculating HRs at each landmark time point (every month), was getting numerically better in the nivolumab + chemotherapy group over time. Approximately 80% of patients who achieved complete response in the nivolumab + chemotherapy group were alive at 3 years. No new safety signals or major late-onset select treatment-related adverse events were observed for nivolumab + chemotherapy.

conclusionThis 3-year follow-up of ATTRACTION-4 confirmed the long-term clinical benefit and manageable safety of nivolumab + chemotherapy in patients with previously untreated advanced gastric cancer.

trial registrationNCT02746796.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionNeoplasm Recurrence, LocalNivolumabStomach NeoplasmsAdultAgedCapecitabineDouble-Blind MethodDrug CombinationsEsophageal NeoplasmsFemaleFollow-Up StudiesHumansMaleCapecitabineDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesNivolumabOxaliplatinOxonic AcidS 1 (combination)TegafurChemotherapyGastric cancerNivolumabOxaliplatinRandomized controlled trial

Identifiers

PMID39162872
PMCPMC11513732

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.