Evidence map›Paper›PMID 30566590›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4).

N Boku, M-H Ryu, K Kato, H C Chung, K Minashi, K-W Lee, H Cho, W K Kang, Y Komatsu, M Tsuda and 6 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 201 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
201citing papers in PubMed, 15 pooled it
20.3field-weighted citation impact, top 1% of its field
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
NCT05299476 phase2completednot on this mapstarted 2022, after this paper: background citation

A Single-arm, Open Phase II Trial of CAPOX Combined With Bevacizumab Combined With Tislelizumab in First-line Treatment of PDL1 CPS < 5 Locally Advanced or Metastati Gastroesophageal Adenocarcinoma

TypeinterventionalSponsorChinese PLA General HospitalRan2022 to 2025Enrolled32ConditionsAdvanced Gastroesophageal Adenocarcinoma, First-line Therapy, PDL1 CPS < 5ArmsCAPOX combined with bevacizumab and Tislelizumab
NCT06576921 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial

TypeinterventionalSponsorXijing HospitalRan2024 to 2026Enrolled116ConditionsStomach Neoplasms, Immune Checkpoint InhibitorsArmsSerplulimab Combined With Chemotherapy, Placebo combined with Chemotherapy
3 · Its place in the literature

Who cites it

201 citing papers in PubMed, 15 syntheses or guidelines pooled it, 318 citations in OpenAlex.

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141 more citing papers are in PubMed but not listed here.

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

16 authors at 15 institutions in 3 countries.

N BokuDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
M-H RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
K KatoDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
H C ChungDepartment of Medical Oncology, Yonsei Cancer Center, Song Dang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.
K MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
K-W LeeDivision of Hematology and Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
H ChoDepartment of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, Tokyo, Japan (previously Kanagawa Cancer Center, Yokohama, Japan.
W K KangDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Y KomatsuDivision of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.
M TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
K YamaguchiDepartment of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
H HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
S FumitaDepartment of Medical Oncology, Nara Hospital Kindai University, Ikoma, Japan.
M AzumaDepartment of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan.
L-T ChenNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Department of Internal Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Y-K KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: ykkang@amc.seoul.kr.
National Cancer Center Hospital East · JPAsan Medical Center · KRChiba Cancer Center · JPHokkaido University Hospital · JPHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPKanagawa Cancer CenterKitasato University · JPNara Medical University Hospital · JPNational Health Research Institutes · TWSaitama Cancer Center · JPSeoul National University Bundang Hospital · KRSungkyunkwan University · KRUlsan College · KRYonsei University Health System · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab is approved as an option for third- or later-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer in several countries after ATTRACTION-2. To further improve the therapeutic efficacy of first-line therapy, exploration of a nivolumab-chemotherapy combination is warranted. In part 1 (phase II) of ATTRACTION-4, the safety and efficacy of nivolumab combined with S-1 plus oxaliplatin (SOX) or capecitabine plus oxaliplatin (CapeOX) as first-line therapy for unresectable advanced or recurrent human epidermal growth factor receptor 2 (HER2)-negative G/GEJ cancer were evaluated. PATIENTS AND

methodsPatients were randomized (1 : 1) to receive nivolumab (360 mg intravenously every 3 weeks) plus SOX (S-1, 40 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2 intravenously on day 1 every 3 weeks) or CapeOX (capecitabine, 1000 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2 intravenously on day 1 every 3 weeks) until disease progression, unacceptable toxicity, or consent withdrawal.

resultsOf 40 randomized patients, 39 (nivolumab plus SOX, 21; nivolumab plus CapeOX, 18) and 38 (21 and 17, respectively) comprised the safety and efficacy populations, respectively. Most frequent (>10%) grade 3/4 treatment-related adverse events were neutropenia (14.3%) in the nivolumab plus SOX group, and neutropenia (16.7%), anemia, peripheral sensory neuropathy, decreased appetite, type 1 diabetes mellitus, and nausea (11.1% each) in the nivolumab plus CapeOX group. No treatment-related death occurred. Objective response rate was 57.1% (95% confidence interval 34.0-78.2) with nivolumab plus SOX and 76.5% (50.1-93.2) with nivolumab plus CapeOX. Median overall survival was not reached (NR) in both groups. Median progression-free survival was 9.7 months (5.8-NR) and 10.6 months (5.6-12.5), respectively.

conclusionNivolumab combined with SOX/CapeOX was well tolerated and demonstrated encouraging efficacy for unresectable advanced or recurrent HER2-negative G/GEJ cancer. ATTRACTION-4 has proceeded to part 2 (phase III) to compare nivolumab plus SOX/CapeOX versus placebo plus SOX/CapeOX. CLINICALTRIALS.GOV ID: NCT02746796.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDrug CombinationsEsophagogastric JunctionFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabOxaliplatinOxonic AcidCapecitabineDrug CombinationsNivolumabOxaliplatinOxonic AcidS 1 (combination)Tegafurcapecitabinegastric/gastroesophageal cancernivolumaboxaliplatinprogrammed death-1S-1

Identifiers

PMID30566590
PMCPMC6386029
OpenAlexW2906436263

What OpenQuestion holds

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LicenceCC BY-NC
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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.