Evidence map›Paper›PMID 20127139›Full record

Trial reportInvestigational new drugs2011

A Phase II, open-label, randomised study to assess the efficacy and safety of the MEK1/2 inhibitor AZD6244 (ARRY-142886) versus capecitabine monotherapy in patients with colorectal cancer who have failed one or two prior chemotherapeutic regimens.

Jaafar Bennouna, Istvan Lang, Manuel Valladares-Ayerbes, Katalin Boer, Antoine Adenis, Pilar Escudero, Tae-You Kim, Gillian M Pover, Clive D Morris, Jean-Yves Douillard

Abstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers.

0numbers the graph read from it
0cells of the map it votes in
77citing 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

77 citing papers in PubMed.

  1. Phase II study of the oral MEK inhibitor selumetinib in advanced acute myelogenous leukemia: a University of Chicago phase II consortium trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Trial
  2. Trial
  3. Multi-institutional phase II study of selumetinib in patients with metastatic biliary cancers.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2011
    Trial
  4. Review
  5. Review
  6. Article
  7. 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
  8. Article
  9. CRISPRingCancers · 2024
    Review
  10. Review
  11. Review
  12. TargetingGastroenterology report · 2023
    Review
  13. Review
  14. Article
  15. Review
  16. Article
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  19. Review
  20. Review

17 more citing papers are in PubMed but not listed here.

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.

Jaafar BennounaMedical Oncology Branch, Centre Rene Gauducheau, Bd J. Monod, 44805 Saint Herblain, France.
Istvan Lang
Manuel Valladares-Ayerbes
Katalin Boer
Antoine Adenis
Pilar Escudero
Tae-You Kim
Gillian M Pover
Clive D Morris
Jean-Yves Douillard

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the efficacy and safety of the MEK1/2 inhibitor AZD6244 (ARRY-142886) in patients with metastatic colorectal cancer who had failed one or two previous chemotherapeutic regimens that included oxaliplatin and/or irinotecan.

methodsThis was a Phase II, multicentre, open-label, randomised, two-arm, parallel-group study comparing AZD6244 with capecitabine monotherapy. Patients received either 100 mg twice daily oral AZD6244 free-base suspension every day or 1,250 mg/m(2) twice daily oral capecitabine, for 2 weeks, followed by a 1-week rest period, in 3-weekly cycles. The primary endpoint was the number of patients experiencing disease progression events.

resultsSixty-nine patients were randomised in the study (34 and 35 patients in the AZD6244 and capecitabine groups, respectively). Disease progression events were experienced by 28 patients (~80%) in both the AZD6244 and capecitabine treatment groups. Median progression-free survival was 81 days and 88 days in the AZD6244 and capecitabine groups, respectively. Ten patients in the AZD6244 treatment arm had a best response of stable disease. For capecitabine, best response was a partial response in one patient, with stable disease in a further 15 patients. The most frequently observed adverse events reported with AZD6244 were acneiform dermatitis, diarrhoea, asthenia and peripheral oedema, compared with hand-foot syndrome, diarrhoea, nausea and abdominal pain with capecitabine.

conclusionsAZD6244 showed similar efficacy to capecitabine in terms of the number of patients with a disease progression event and of progression-free survival. AZD6244 is currently undergoing evaluation in Phase II trials in combination with other chemotherapeutic agents.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzimidazolesCapecitabineColorectal NeoplasmsDemographyDeoxycytidineDisease-Free SurvivalDisease ProgressionDose-Response Relationship, DrugFemaleFluorouracilHumansMaleAntineoplastic AgentsAZD 6244BenzimidazolesCapecitabineDeoxycytidineFluorouracilMitogen-Activated Protein Kinase KinasesProtein Kinase Inhibitors

Identifiers

What OpenQuestion holds

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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.