Evidence map›Paper›PMID 35869145›Full record

Trial reportBritish journal of cancer2022

Randomised, Phase II study of selumetinib, an oral inhibitor of MEK, in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer.

Mark K Doherty, Vincent C Tam, Mairéad G McNamara, Raymond Jang, David Hedley, Eric Chen, Neesha Dhani, Patricia Tang, Hao-Wen Sim, Grainne M O'Kane and 4 more

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

Trial report in British journal of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Biliary tract cancers: advances in diagnostic and management.Exploration of targeted anti-tumor therapy · 2025
    Review
  10. Article
  11. Article
  12. 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

14 authors at 3 institutions in 2 countries.

Mark K DohertyDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.ORCID http://orcid.org/0000-0001-8864-7754
Vincent C TamDepartment of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Mairéad G McNamaraDivision of Cancer Sciences, University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.ORCID http://orcid.org/0000-0002-2272-3678
Raymond JangDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
David HedleyDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Eric ChenDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Neesha DhaniDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Patricia TangDepartment of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Hao-Wen SimDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Grainne M O'KaneDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-8690-403X
Stephanie DeLucaPharmacy, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Lisa WangDepartment of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Theresa PedutemDrug Development Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Jennifer J KnoxDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. Jennifer.knox@uhn.ca.ORCID http://orcid.org/0000-0003-3474-6647
University of Toronto · CAPrincess Margaret Cancer Centre · CAUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCisplatin and gemcitabine (CisGem) are standard chemotherapy for advanced biliary tract cancer (BTC). The MEK inhibitor selumetinib showed synergy with gemcitabine when administered sequentially in BTC. This randomised Phase 2 trial aimed to assess the efficacy of sequential or continuous selumetinib with CisGem.

methodsPatients with advanced BTC received CisGem; arm A included selumetinib every day, arm B: selumetinib, days 1-5, 8-19 each cycle. Arm C received CisGem alone. Selumetinib was dosed at 75 mg BID but amended to 50 mg BID due to toxicity.

resultsIn all, 51 participants were evaluable for response. No significant difference was seen in mean change in tumour size at 10 weeks between arms A and C (-7.8% vs -12.8%, P = 0.54) or arms B and C (-15% vs -12.8%, P = 0.78). There was no difference in median progression-free survival (6.0, 7.0, 6.3 months, P > 0.95) or overall survival (11.7, 11.7, 12.8 months, P = 0.70) for arms A, B and C, respectively. More participants experienced grade 3-4 toxicities in selumetinib-containing arms. More participants in arm A required chemotherapy dose reductions (P = 0.01) with lower chemotherapy dose intensity during the first 10 weeks.

conclusionAdding sequential or continuous selumetinib to CisGem failed to improve efficacy and increased toxicity in patients with advanced BTC.

Indexed as

Bile Duct NeoplasmsBiliary Tract NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCisplatinDeoxycytidineGemcitabineHumansMitogen-Activated Protein Kinase KinasesAZD 6244BenzimidazolesCisplatinDeoxycytidineGemcitabineMitogen-Activated Protein Kinase Kinases

Identifiers

PMID35869145
PMCPMC9554033
OpenAlexW4286561096

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.