Evidence map›Paper›PMID 30088161›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer.

Sebastian Mondaca, Matthew Margolis, Francisco Sanchez-Vega, Philip Jonsson, Jamie C Riches, Geoffrey Y Ku, Jaclyn F Hechtman, Yaelle Tuvy, Michael F Berger, Manish A Shah and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00515411 (A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 15% 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.

NCT00515411 phase2completednot on this map

A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2006 to 2018Enrolled111ConditionsGastroesophageal Junction Adenocarcinoma, Gastric CancerArmsDocetaxel, Leucovorin, Fluorouracil, Cisplatin, Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen, Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 21 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

22 authors at 3 institutions in 1 country.

Sebastian MondacaDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Matthew MargolisDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Francisco Sanchez-VegaHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Philip JonssonHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Jamie C RichesDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Geoffrey Y KuDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Jaclyn F HechtmanMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Yaelle TuvyDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Michael F BergerHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Manish A ShahDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
David P KelsenDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
David H IlsonDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Kenneth YuDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Zoe GoldbergDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Andrew S EpsteinDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Avni DesaiDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Vincent ChungDepartment of Medical Oncology and Therapeutics Research, City of Hope Cancer Center, Duarte, CA, USA.
Joanne F ChouDepartment of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Marinela CapanuDepartment of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
David B SolitDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
Nikolaus SchultzHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Yelena Y JanjigianDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA. janjigiy@mskcc.org.
Memorial Sloan Kettering Cancer Center · USCornell University · USCity of Hope · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundTrastuzumab with cisplatin and fluoropyrimidine is the standard treatment in metastatic HER2-positive gastric or gastroesophageal (GE) junction adenocarcinoma; however, there is limited data on the efficacy of trastuzumab in combination with a three-drug regimen in this setting. We examined the efficacy and safety of modified docetaxel, cisplatin and 5 fluorouracil (mDCF) plus trastuzumab in a single-arm multicenter phase II trial.

methodsPreviously untreated patients with HER2-positive metastatic gastric or GE junction adenocarcinoma were treated with mDCF and trastuzumab every 2 weeks. The primary endpoint was 6-month progression-free survival (PFS); secondary endpoints included objective response rate, overall survival (OS), and toxicity.

resultsWe enrolled 26 patients with metastatic HER2-positive gastric or GE junction adenocarcinoma between February 2011 and June 2015. The median age of patients was 62 years; 96% had a Karnofsky performance status equal to or greater than 80%. With a median follow-up of 25.4 months, the 6-month PFS was 73% (95% CI 51-86%). The objective response rate was 65%, the median PFS was 13 months (95% CI 6.4-20.7) and the median OS was 24.9 months (95% CI 14.4-42.5). Grade 3/4 toxicities included neutropenia (42%), fatigue (23%), and hypophosphatemia (15%). There were no episodes of febrile neutropenia.

conclusionThe combination of mDCF and trastuzumab is effective and safe in patients with metastatic HER2-positive gastric or GE junction adenocarcinoma and can be considered as an option for selected patients. This trial is registered at ClinicalTrials.gov, number NCT00515411.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinDocetaxelErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionFemaleFluorouracilHumansMaleMiddle AgedProgression-Free SurvivalStomach NeoplasmsTrastuzumabCisplatinDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorouracilTrastuzumabDocetaxelGastric cancerHER2Trastuzumab

Identifiers

PMID30088161
PMCPMC6784321
OpenAlexW2887352196

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.