Evidence map›Paper›PMID 33577358›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1).

Manish A Shah, Gyorgy Bodoky, Alexander Starodub, David Cunningham, Desmond Yip, Zev A Wainberg, Johanna Bendell, Dung Thai, Joyce He, Pankaj Bhargava and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02545504 (A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma), which is not on this map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
4.8field-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.

NCT02545504 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

TypeinterventionalSponsorGilead SciencesRan2015 to 2019Enrolled432ConditionsGastric AdenocarcinomaArmsAndecaliximab, Placebo, Leucovorin, 5-fluorouracil, Oxaliplatin
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 69 citations in OpenAlex.

  1. Trial
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  11. Interactions between cancer-associated fibroblasts and the extracellular matrix in oesophageal cancer.Matrix biology : journal of the International Society for Matrix Biology · 2025
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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

11 authors at 9 institutions in 4 countries.

Manish A ShahWeill Cornell Medicine, NewYork-Presbyterian Hospital, New York, NY.ORCID 0000-0002-6913-9655
Gyorgy BodokySzent László Hospital, Budapest, Hungary.
Alexander StarodubRiverside Peninsula Cancer Institute, Riverside Cancer Care Center, Newport News, VA.
David CunninghamThe Royal Marsden NHS Foundation Trust, Sutton and London Hospital, Sutton, United Kingdom.ORCID 0000-0001-5158-1069
Desmond YipANU Medical School, Australian National University, Canberra, Australia.ORCID 0000-0002-2806-2401
Zev A WainbergDavid Geffen School of Medicine at UCLA, Los Angeles, CA.ORCID 0000-0002-7142-1246
Johanna BendellSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
Dung ThaiGilead Sciences, Inc, Foster City, CA.
Joyce HeGilead Sciences, Inc, Foster City, CA.
Pankaj BhargavaGilead Sciences, Inc, Foster City, CA.ORCID 0000-0002-0647-1386
Jaffer A AjaniThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9946-0629
Gilead Sciences (United States) · USAustralian National University · AUNewYork–Presbyterian Hospital · USRiverside Regional Medical Center · USRoyal Marsden NHS Foundation Trust · GBSarah Cannon · USThe University of Texas MD Anderson Cancer Center · USUnified Szent István and Szent László Hospital · HUUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAndecaliximab (ADX) is a monoclonal antibody that inhibits matrix metalloproteinase 9, an extracellular enzyme involved in matrix remodeling, tumor growth, and metastases. A phase I and Ib study of modified oxaliplatin, leucovorin, and fluorouracil (mFOLFOX6) with ADX revealed encouraging antitumor activity in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. MATERIALS AND

methodsThis phase III, randomized, double-blinded, placebo (PBO)-controlled multicenter study investigated the efficacy and safety of mFOLFOX6 with and without ADX in patients with untreated human epidermal growth factor receptor 2-negative gastric or GEJ adenocarcinoma. Random assignment was 1:1 to mFOLFOX6 + ADX or mFOLFOX6 + PBO. ADX/PBO 800 mg was infused on days 1 and 15 of each 28-day cycle. Protocol therapy was given until disease progression or intolerance. The primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), objective response rate (RECIST 1.1), and safety.

resultsBetween September 2015 and May 2017, 432 patients were randomly assigned, 218 to ADX and 214 to PBO. The median OS was 12.5 versus 11.8 months in the ADX and PBO groups, respectively. The median PFS was 7.5 versus 7.1 months in the ADX and PBO groups, respectively. The objective response rate was 51% in the ADX group and 41% in the PBO group. Among the subgroup analyses, patients of age ≥ 65 years had an improved OS and PFS with ADX versus PBO; the

conclusionThe addition of ADX to mFOLFOX6 did not improve OS in unselected patients with untreated human epidermal growth factor receptor 2-negative gastric or GEJ adenocarcinoma.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodEsophagogastric JunctionFemaleFluorouracilFollow-Up StudiesHumansLeucovorinMaleMiddle AgedOxaliplatinandecaliximabAntibodies, Monoclonal, HumanizedFluorouracilLeucovorinOxaliplatin

Identifiers

PMID33577358
PMCPMC8078292
OpenAlexW3127702912

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.