Evidence map›Paper›PMID 33105819›Full record

ArticleCancers2020

Combination Therapy of High-Dose Rabeprazole Plus Metronomic Capecitabine in Advanced Gastro-Intestinal Cancer: A Randomized Phase II Trial.

Michela Roberto, Adriana Romiti, Federica Mazzuca, Annalisa Milano, Chiara D'Antonio, Luana Lionetto, Rosa Falcone, Lidia Strigari, Maurizio Simmaco, Stefano Fais and 1 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 29% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
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.

Michela RobertoDepartment of Clinical and Molecular Medicine, University "La Sapienza", 00189 Roma, Italy.ORCID 0000-0001-5339-8348
Adriana RomitiDepartment of Clinical and Molecular Medicine, University "La Sapienza", 00189 Roma, Italy.
Federica MazzucaDepartment of Clinical and Molecular Medicine, University "La Sapienza", 00189 Roma, Italy.
Annalisa MilanoOncology Unit, Sant' Andrea University Hospital, 00189 Roma, Italy.
Chiara D'AntonioOncology Unit, Sant' Andrea University Hospital, 00189 Roma, Italy.
Luana LionettoMass Spectrometry Lab-Clinical Biochemistry Unit, Sant'Andrea University Hospital, 00189 Rome, Italy.
Rosa FalconeDepartment of Translational and Precision medicine, University "La Sapienza", viale dell'Università 37, 00185 Rome, Italy.
Lidia StrigariDepartment of Medical physics, Policlinico S.Orsola Malpighi, 40138 Bologna, Italy.
Maurizio SimmacoDepartment of Neurosciences, Mental Health and Sensory Organs, University "La Sapienza", via di Grottarossa 1035, 00189 Roma, Italy.
Stefano FaisDepartment of Oncology and Molecular Medicine, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy.
Paolo MarchettiDepartment of Clinical and Molecular Medicine, University "La Sapienza", 00189 Roma, Italy.
Sapienza University of Rome · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITIstituto Superiore di Sanità · IT

Funding

Ministero della Salute NA
6 · The paper itself

Abstract

backgroundIn recent years, proton pump inhibitors (PPIs) have been investigated at high-dose to modulate tumor microenvironment acidification thus restoring chemotherapeutic sensitivity. This is the first trial to study activity and safety of repurposing high dose rabeprazole combined with metronomic capecitabine (mCAP).

methodsA phase II study in which patients with gastrointestinal cancer, refractory to standard treatments, who had a life expectancy >3 months, were blind randomized 1:1 to mCAP, 1500 mg/daily, continuously with or without rabeprazole 1.5 mg/kg bid, three days a week. The primary endpoint was 3-months progression-free survival (PFS). The secondary endpoints were clinical benefit (CB) and overall survival (OS). Safety and plasma concentrations of capecitabine and its metabolites (5'-DFUR and 5-FU) were also evaluated.

resultsSixty-seven (median age 69 years; 63% male; 84% colorectal cancer, 76% ECOG-PS ≤ 1; 84% pretreated with two or more lines of chemotherapy) out of 90 patients screened for eligibility, were randomized to receive mCAP+rabeprazole (

conclusionsAlthough the adjunct of high dose rabeprazole to mCAP was not shown to affect mCAP activity, as PPI are being investigated worldwide as drugs to be repositioned in cancer treatment and also considering the limited sample size as well as the favorable safety profile of the combination in the present study, further clinical investigations are desirable.

Indexed as

combination therapydrug repurposinggastrointestinal cancermetronomic capecitabineproton-pump inhibitors (PPIs)

Identifiers

PMID33105819
PMCPMC7690608
OpenAlexW3093833980

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.