Evidence map›Paper›PMID 26354521›Full record

Trial reportMedical oncology (Northwood, London, England)2015

Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial.

Sebastian Ochenduszko, Miroslawa Puskulluoglu, Kamil Konopka, Kamil Fijorek, Katarzyna Urbanczyk, Andrzej Budzynski, Maciej Matlok, Agata Lazar, Anna Sinczak-Kuta, Michal Pedziwiatr and 1 more

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

Trial report in Medical oncology (Northwood, London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02445209 (Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma), which is not on this map. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT02445209 phase3completednot on this map

Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

TypeinterventionalSponsorJagiellonian UniversityRan2010 to 2014Enrolled56ConditionsHER2 Negative Gastric CancerArmsEOX, mDCF
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  3. Chemotherapy for advanced gastric cancer.The Cochrane database of systematic reviews · 2017
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  7. Meta-Analysis of Capecitabine versus 5-Fluorouracil in Advanced Gastric Cancer.Evidence-based complementary and alternative medicine : eCAM · 2023
    Review
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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 3 institutions in 1 country.

Sebastian OchenduszkoDepartment of Oncology, Jagiellonian University Medical College, Ul.Sniadeckich 10, 31-531, Kraków, Poland. sebaochenduszko@gmail.com.ORCID http://orcid.org/0000-0002-0126-8418
Miroslawa PuskulluogluDepartment of Oncology, Jagiellonian University Medical College, Ul.Sniadeckich 10, 31-531, Kraków, Poland.
Kamil KonopkaDepartment of Clinical Oncology, University Hospital in Krakow, Kraków, Poland.
Kamil FijorekDepartment of Statistics, Cracow University of Economics, Kraków, Poland.
Katarzyna UrbanczykDepartment of Pathology, Jagiellonian University Medical College, Kraków, Poland.
Andrzej Budzynski2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Poland.
Maciej Matlok2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Poland.
Agata LazarDepartment of Pathology, Jagiellonian University Medical College, Kraków, Poland.
Anna Sinczak-KutaDepartment of Pathology, Jagiellonian University Medical College, Kraków, Poland.
Michal Pedziwiatr2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Poland.
Krzysztof KrzemienieckiDepartment of Oncology, Jagiellonian University Medical College, Ul.Sniadeckich 10, 31-531, Kraków, Poland.
Jagiellonian University · PLKrakow Cardiovascular Research Institute · PLKrakow University of Economics · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the study was to compare efficacy and safety of first-line palliative chemotherapy with (EOX) epirubicin/oxaliplatin/capecitabine and (mDCF) docetaxel/cisplatin/5FU/leucovorin regimens for untreated advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. Fifty-six patients were randomly assigned to mDCF (docetaxel 40 mg/m(2) day 1, leucovorin 400 mg/m(2) day 1, 5FU 400 mg/m(2) bolus day 1, 5FU 1000 mg/m(2)/d days 1 and 2, cisplatin 40 mg/m(2) day 3) or EOX (epirubicin 50 mg/m(2) day 1, oxaliplatin 130 mg/m(2) day 1, capecitabine 1250 mg/m(2)/d days 1-21). The primary endpoint was overall survival. The median overall survival was 9.5 months with EOX and 11.9 months with mDCF (p = 0.135), while median progression-free survival was 6.4 and 6.8 months, respectively (p = 0.440). Two-year survival rate was 22.2 % with mDCF compared to 5.2 % with EOX. Patients in the EOX arm had more frequent reductions in chemotherapy doses (34.5 vs. 3.7 %; p = 0.010) and delays in subsequent chemotherapy cycles (82.8 vs. 63.0 %; p = 0.171). There was no statistically significant difference in the rates of grade 3-4 adverse events (EOX 79.3 vs. mDCF 61.5 %; p = 0.234). As compared with the mDCF, the EOX regimen was associated with more frequent nausea (34.5 vs. 15.4 %), thromboembolic events (13.8 vs. 7.7 %), abdominal pain (13.8 vs. 7.7 %) and grades 3-4 neutropenia (72.4 vs. 50.0 %), but lower incidences of anemia (44.8 vs. 61.5 %), mucositis (6.9 vs. 15.4 %) and peripheral neuropathy (6.9 vs. 15.4 %). In conclusion, the mDCF regimen was associated with a statistically nonsignificant 2.4-month longer median overall survival without an increase in toxicity. This trial is registered at ClinicalTrials.gov, number NCT02445209.

Indexed as

Esophagogastric JunctionPalliative CareAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCisplatinDisease-Free SurvivalEpirubicinErb-b2 Receptor Tyrosine KinasesEsophageal NeoplasmsFemaleFluorouracilHumansKaplan-Meier EstimateLeucovorinMaleCapecitabineCisplatinEpirubicinErb-b2 Receptor Tyrosine KinasesFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatinEOXGastric cancermDCFPalliative chemotherapySafetyToxicity

Identifiers

PMID26354521
PMCPMC4564435
OpenAlexW2179576001

What OpenQuestion holds

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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.