Evidence map›Paper›PMID 31087200›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2020

Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer.

Taroh Satoh, Yoon-Koo Kang, Yee Chao, Min-Hee Ryu, Ken Kato, Hyun Cheol Chung, Jen-Shi Chen, Kei Muro, Won Ki Kang, Kun-Huei Yeh and 15 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 8 pooled it
6.5field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 8 syntheses or guidelines pooled it, 59 citations in OpenAlex.

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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

25 authors at 20 institutions in 3 countries.

Taroh SatohFrontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Yoon-Koo KangDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Yee ChaoDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Min-Hee RyuDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Ken KatoDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Hyun Cheol ChungDivision of Medical Oncology, Yonsei Cancer Center, Song-Dang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.
Jen-Shi ChenDivision of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Won Ki KangDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Kun-Huei YehDepartment of Oncology, National Taiwan University Hospital, and National Taiwan University Cancer Center, Taipei, Taiwan.
Takaki YoshikawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Sang Cheul OhDivision of Hematology and Oncology, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
Li-Yuan BaiDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.
Takao TamuraDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
Keun-Wook LeeDivision of Hematology and Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Yasuo HamamotoKeio Cancer Center, Keio University School of Medicine, Tokyo, Japan.
Jong Gwang KimSchool of Medicine, Kyungpook National University, Daegu, South Korea.
Keisho ChinDepartment of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Jae Yong ChoDepartment of Medical Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
Mitsunobu TanimotoOncology Clinical Development Planning, Oncology Clinical Development Unit, ONO Pharmaceutical Co., Ltd., Osaka, Japan.
Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, and National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Narikazu BokuDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. nboku@ncc.go.jp.
Aichi Cancer Center · JPAsan Medical Center · KRChang Gung University · TWChiba Cancer Center · JPChina Medical University Hospital · TWGangnam Severance Hospital · KRHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPKeio University · JPKindai University · JPKorea University · KRKyungpook National University · KRNational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TWOno Pharmaceutical (Japan) · JPSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRSungkyunkwan University · KRTaipei Veterans General Hospital · TWThe University of Osaka · JP

Funding

Funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Inc., Princeton, NJ. NA
6 · The paper itself

Abstract

backgroundData on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients.

methodsIn ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed.

resultsOf 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab-. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3-12.9] vs 3.1 [1.9-5.3] months, hazard ratio, 0.38 [0.22-0.66]; P = 0.0006; Tmab-, 4.8 [4.1-6.0] vs 4.2 [3.6-4.9] months, 0.71 [0.57-0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001).

conclusionsNivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalDouble-Blind MethodEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansMaleMiddle AgedNivolumabPlacebosStomach NeoplasmsTrastuzumabTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabPlacebosTrastuzumabGastric cancerGastroesophageal junction cancerNivolumabTrastuzumab

Identifiers

PMID31087200
PMCPMC6942596
OpenAlexW2945045362

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.