Evidence map›Paper›PMID 30052729›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300.

Y-J Bang, E Yañez Ruiz, E Van Cutsem, K-W Lee, L Wyrwicz, M Schenker, M Alsina, M-H Ryu, H-C Chung, L Evesque and 10 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter 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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 298 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
298citing papers in PubMed, 26 pooled it
45.3field-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.

NCT02625623 phase3completednot on this map

A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2015 to 2019Enrolled371ConditionsUnresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Gastric Cancer Third LineArmsAvelumab, Irinotecan, Paclitaxel, Best Supportive Care (BSC)
NCT05213312 phase2 / phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

A Randomized, Multicenter, Double Blind, Phase II Study of Neoadjuvant Nivolumab or Placebo Plus Chemotherapy Followed by Surgery and Adjuvant Treatment in Subjects With Resectable Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2024Enrolled90ConditionsEsophageal Squamous Cell CarcinomaArmsNivolumab, Cisplatin, Paclitaxel, 5Fluorouracil, Esophagectomy (minimally invasive)
3 · Its place in the literature

Who cites it

298 citing papers in PubMed, 26 syntheses or guidelines pooled it, 502 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 9 countries.

Y-J BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: bangyj@snu.ac.kr.
E Yañez RuizUniversidad de la Frontera, Temuco, Chile.
E Van CutsemDepartment of Digestive Oncology, University Hospitals Gasthuisberg/Leuven, KU Leuven, Leuven, Belgium.
K-W LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
L WyrwiczDepartment of Gastrointestinal Cancer, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.
M SchenkerCentrul de Oncologie Sf. Nectarie, Craiova, Romania.
M AlsinaDepartment of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
M-H RyuDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
H-C ChungDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.
L EvesqueDepartment of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
S-E Al-BatranDepartment of Clinical Oncology and Hematology, Krankenhaus Nordwest, Frankfurt, Germany.
S H ParkDepartment of Medicine, Samsung Medical Center, Seoul, South Korea.
M LichinitserDepartment of Chemotherapy and Combined Therapy, N. N. Blokhin Russian Oncological Scientific Center, Russian Academy of Medical Sciences, Moscow, Russian Federation.
N BokuDepartment of Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
M H MoehlerDepartment of Internal Medicine, Johannes Gutenberg University Mainz, Mainz, Germany.
J HongGlobal Clinical Development Immuno-Oncology, EMD Serono, Billerica, USA.
H XiongGlobal Clinical Development Immuno-Oncology, EMD Serono, Billerica, USA.
R HallwachsGlobal Research & Development, Merck KGaA, Darmstadt, Germany.
I ContiGlobal Clinical Development Immuno-Oncology, EMD Serono, Billerica, USA.
J TaiebDepartment of Gastroenterology and Digestive Oncology, Université Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.
Ono Pharmaceutical (United States) · USCentre Antoine Lacassagne · FRJohannes Gutenberg University Mainz · DEKrankenhaus Nordwest · DEKU Leuven · BEMerck (Germany) · DENational Cancer Center Hospital East · JPSamsung Medical Center · KRSeoul National University · KRSeoul National University Bundang Hospital · KRSorbonne Université · FRThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUlsan College · KRUniversidad de La Frontera · CLVall d'Hebron Institute of OncologyYonsei University Health System · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase III JAVELIN Gastric 300 trial compared avelumab versus physician's choice of chemotherapy as third-line therapy in patients with advanced GC/GEJC. Patients and methods: Patients with unresectable, recurrent, locally advanced, or metastatic GC/GEJC were recruited at 147 sites globally. All patients were randomised to receive either avelumab 10 mg/kg by intravenous infusion every 2 weeks or physician's choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Results: A total of 371 patients were randomised. The trial did not meet its primary end point of improving OS {median, 4.6 versus 5.0 months; hazard ratio (HR)=1.1 [95% confidence interval (CI) 0.9-1.4]; P = 0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR=1.73 (95% CI 1.4-2.2); P > 0.99] or ORR (2.2% versus 4.3%) in the avelumab versus chemotherapy arms, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 90 patients (48.9%) and 131 patients (74.0%) in the avelumab and chemotherapy arms, respectively. Grade ≥3 TRAEs occurred in 17 patients (9.2%) in the avelumab arm and in 56 patients (31.6%) in the chemotherapy arm. Conclusions: Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy. Avelumab showed a more manageable safety profile than chemotherapy. Trial registration: ClinicalTrials.gov: NCT02625623.

Indexed as

Choice BehaviorAdenocarcinomaAdenocarcinoma, MucinousAdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, PapillaryCarcinoma, Signet Ring CellDecision Support TechniquesEsophageal NeoplasmsEsophagogastric JunctionFemaleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabIrinotecanPaclitaxel

Identifiers

PMID30052729
PMCPMC6225815
OpenAlexW2883552436

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.