Evidence map›Paper›PMID 38714747›Full record

ArticleBritish journal of cancer2024

Prospective manipulation of the gut microbiome with microbial ecosystem therapeutic 4 (MET4) in HPV-related locoregionally-advanced oropharyngeal cancer squamous cell carcinoma (LA-OPSCC) undergoing primary chemoradiation: ROMA2 study.

Marc Oliva, Alya Heirali, Geoffrey Watson, Ashley M Rooney, Kyla Cochrane, Sarah Jennings, Rachel Taylor, Minge Xu, Ali Hosni, Andrew Hope and 11 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

21 authors.

Marc OlivaDepartment of Medical Oncology, Catalan Institute of Oncology, Barcelona, Spain.ORCID 0000-0001-5352-8130
Alya HeiraliToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Geoffrey WatsonDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Ashley M RooneyToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Kyla CochraneNubiyota LLP, Guelph, ON, Canada.
Sarah JenningsDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Rachel TaylorDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Minge XuDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Ali HosniDepartment of Radiation Oncology, University of Toronto; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Andrew HopeDepartment of Radiation Oncology, University of Toronto; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Scott V BratmanDepartment of Radiation Oncology, University of Toronto; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Douglas ChepehaDepartment of Otolaryngology- Head & Neck Surgery/Surgical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Ilan WeinrebDepartment of Pathology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Bayardo Perez-OrdonezDepartment of Pathology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Ricard Mesia NinDepartment of Medical Oncology, Catalan Institute of Oncology, Barcelona, Spain.
John WaldronDepartment of Radiation Oncology, University of Toronto; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Wei XuBiostatistics Department, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Aaron R HansenDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Lillian L SiuDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.ORCID 0000-0002-3500-0540
Bryan CoburnToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada. bryan.coburn@uhn.ca.ORCID 0000-0003-0150-4510
Anna SpreaficoDivision of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. anna.spreafico@uhn.ca.ORCID 0000-0002-3034-3042

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGut microbiome modulation to boost antitumor immune responses is under investigation.

methodsROMA-2 evaluated the microbial ecosystem therapeutic (MET)-4 oral consortia, a mixture of cultured human stool-derived immune-responsiveness associated bacteria, given with chemoradiation (CRT) in HPV-related oropharyngeal cancer patients. Co-primary endpoints were safety and changes in stool cumulative MET-4 taxa relative abundance (RA) by 16SRNA sequencing. Stools and plasma were collected pre/post-MET-4 intervention for microbiome and metabolome analysis.

resultsTwenty-nine patients received ≥1 dose of MET-4 and were evaluable for safety: drug-related adverse events (AEs) occurred in 13/29 patients: all grade 1-2 except one grade 3 (diarrhea). MET-4 was discontinued early in 7/29 patients due to CRT-induced toxicity, and in 1/29 due to MET-4 AEs. Twenty patients were evaluable for ecological endpoints: there was no increase in stool MET-4 RA post-intervention but trended to increase in stage III patients (p = 0.06). MET-4 RA was higher in stage III vs I-II patients at week 4 (p = 0.03) and 2-month follow-up (p = 0.01), which correlated with changes in plasma and stool targeted metabolomics.

conclusionsROMA-2 did not meet its primary ecologic endpoint, as no engraftment was observed in the overall cohort. Exploratory findings of engraftment in stage III patients warrants further investigation of microbiome interventions in this subgroup.

Indexed as

ChemoradiotherapyGastrointestinal MicrobiomeOropharyngeal NeoplasmsPapillomavirus InfectionsAdultAgedFecesFemaleHumansMaleMiddle AgedProspective StudiesSquamous Cell Carcinoma of Head and Neck

Identifiers

PMID38714747
PMCPMC11183079

What OpenQuestion holds

Textmetadata
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.