Evidence map›Paper›PMID 29696360›Full record

Trial reportCancer chemotherapy and pharmacology2018

Randomized phase 2 study of gemcitabine and cisplatin with or without vitamin supplementation in patients with advanced esophagogastric cancer.

A A van Zweeden, C J van Groeningen, R J Honeywell, E Giovannetti, R Ruijter, C H Smorenburg, G Giaccone, H M W Verheul, G J Peters, Hans J van der Vliet

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Roles of long non-coding RNAs in oesophageal cancer pathogenesis.International journal of experimental pathology · 2025
    Review
  4. Review
  5. Article
  6. Review
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

10 authors at 4 institutions in 2 countries.

A A van ZweedenDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
C J van GroeningenDepartment of Internal Medicine, Amstelland Hospital, Amstelveen, The Netherlands.
R J HoneywellDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
E GiovannettiDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
R RuijterDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
C H SmorenburgDepartment of Internal Medicine, Noordwest Ziekenhuisgroep Alkmaar, Alkmaar, The Netherlands.
G GiacconeDepartment of Medical Oncology, Georgetown University Medical Center, Washington, DC, USA.
H M W VerheulDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
G J PetersDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Hans J van der VlietDepartment of Medical Oncology, VU University Medical Center, Room 3A38, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. jj.vandervliet@vumc.nl.
Amsterdam UMC Location VUmc · NLZiekenhuis Amstelland · NLGeorgetown University · USNoordwest Ziekenhuisgroep · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePreclinical research and prior clinical observations demonstrated reduced toxicity and suggested enhanced efficacy of cisplatin due to folic acid and vitamin B12 suppletion. In this randomized phase 2 trial, we evaluated the addition of folic acid and vitamin B12 to first-line palliative cisplatin and gemcitabine in patients with advanced esophagogastric cancer (AEGC).

methodsPatients with AEGC were randomized to gemcitabine 1250 mg/m

resultsAdenocarcinoma cells cultured in medium with high folate levels were more sensitive to cisplatin and this was associated with increased intracellular platinum levels. In the randomized phase 2 clinical trial, which ran from October 2004 to September 2013, treatment was initiated in 78 of 82 randomized pts, 39 in each study arm. The RR was similar; 42.1% for supplemented patients vs. 32.4% for unsupplemented patients; p = 0.4. Median OS and TTP were 10.0 and 5.9 months for supplemented vs. 7.7 and 5.4 months for unsupplemented patients (OS, p = 0.9; TTP, p = 0.9). Plasma homocysteine was lower in the supplemented group [n = 20, 6.9 ± 1.6 (mean ± standard error of mean, SEM) µM; vs. 12.5 ± 4.0 µM; p < 0.001]. There was no significant difference in the C

conclusionFolic acid and vitamin B12 supplementation do not improve the RR, PFS, or OS of cisplatin and gemcitabine in patients with AEGC.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineDietary SupplementsDrug SynergismEsophageal NeoplasmsFemaleFolic AcidGemcitabineHumansMaleMiddle AgedCisplatinDeoxycytidineFolic AcidGemcitabineVitamin B 12CisplatinEsophagogastric cancerFolic acidGemcitabineVitamin B12

Identifiers

PMID29696360
PMCPMC6010482
OpenAlexW2802875571

What OpenQuestion holds

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LicenceCC BY
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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.