Evidence map›Paper›PMID 31312030›Full record

ArticleBritish journal of cancer2019

Enhanced antitumor effect of binimetinib in combination with capecitabine for biliary tract cancer patients with mutations in the RAS/RAF/MEK/ERK pathway: phase Ib study.

Jin Won Kim, Kyung-Hun Lee, Ji-Won Kim, Koung Jin Suh, Ah-Rong Nam, Ju-Hee Bang, Yung-Jue Bang, Do-Youn Oh

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

Article in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02773459 (Phase Ib Study of MEK162 in Combination With Capecitabine in Gemcitabine-pretreated Advanced Biliary Tract Cancer), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.1field-weighted citation impact, top 9% 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.

NCT02773459 phase1 / phase2completednot on this map

Phase Ib Study of MEK162 in Combination With Capecitabine in Gemcitabine-pretreated Advanced Biliary Tract Cancer

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2019Enrolled31ConditionsBiliary Tract CancerArmsMEK162+capecitabine
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Review
  3. Mucocutaneous toxicities from MEK inhibitors: a scoping review of the literature.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  4. Review
  5. Molecules (Basel, Switzerland) · 2023
    Article
  6. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. 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

8 authors at 3 institutions in 3 countries.

Jin Won KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.ORCID http://orcid.org/0000-0002-1357-7015
Kyung-Hun LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Ji-Won KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Koung Jin SuhDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Ah-Rong NamCancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Ju-Hee BangCancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. ohdoyoun@snu.ac.kr.
Seoul National University · KRSeoul National University Bundang Hospital · KRCancer Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase Ib study of binimetinib and capecitabine for gemcitabine-pretreated biliary tract cancer (BTC) patients was conducted.

methodsBinimetinib and capecitabine were dosed twice daily on days 1-14, in 3-week cycles. In the dose-escalation (DE) part, three dose levels (DL) were tested (DL1: binimetinib/capecitabine, 15 mg/1000 mg/m

resultsIn the DE part, nine patients were recruited and no dose-limiting toxicity was noted. Therefore, the recommended phase 2 dose was determined as DL3. In the expansion part, 25 patients were enrolled. In total, 34 patients, 25 (73.5%) and 9 patients (26.5%) were second-line and third-line settings, respectively. The 3-month progression-free survival (PFS) rate was 64.0%, and the median PFS and overall survival (OS) were 4.1 and 7.8 months. The objective response rate and disease control rate were 20.6% and 76.5%. In total, 68.4% of stable diseases were durable (> 12 weeks). Furthermore, patients with RAS/RAF/MEK/ERK pathway mutations (38.5%) showed significantly better tumour response (p = 0.028), PFS (5.4 vs. 3.5 months, p = 0.010) and OS (10.8 vs. 5.9 months, p = 0.160) than wild type. Most of the adverse events were grade 1/2 and manageable.

conclusionsA combination of binimetinib and capecitabine shows acceptable tolerability and promising antitumor efficacy for gemcitabine-pretreated BTC, especially in patients with RAS/RAF/MEK/ERK pathway mutations. CLINICAL

trial registrationClinicalTrials.gov (Identifier: NCT02773459).

Indexed as

MutationAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBiliary Tract NeoplasmsCapecitabineCell Line, TumorExtracellular Signal-Regulated MAP KinasesFemaleHumansMaleMiddle AgedMitogen-Activated Protein Kinase KinasesQuality of Liferaf Kinasesras ProteinsBenzimidazolesbinimetinibCapecitabineExtracellular Signal-Regulated MAP KinasesMitogen-Activated Protein Kinase Kinasesraf Kinasesras Proteins

Identifiers

PMID31312030
PMCPMC6738070
OpenAlexW2957765331

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.