Evidence map›Paper›PMID 41768125›Full record

ArticleNeuro-oncology advances

A phase 2 study of abemaciclib in patients with brain metastases secondary to non-small cell lung cancer or melanoma.

Solmaz Sahebjam, Danielle A Bazer, Emilie Le Rhun, Paola Queirolo, Guy Jerusalem, Erica L Johnston, Pierfranco Conte

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02308020 (A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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.

NCT02308020 phase2completednot on this map

A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2019Enrolled162ConditionsBreast Cancer, Non-small Cell Lung Cancer, Melanoma, Brain MetastasesArmsAbemaciclib
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Solmaz SahebjamDepartment of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine,Baltimore, Maryland, USA (S.S., D.A.B.).ORCID https://orcid.org/0000-0001-9930-9937
Danielle A BazerDepartment of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine,Baltimore, Maryland, USA (S.S., D.A.B.).ORCID https://orcid.org/0000-0001-9459-7773
Emilie Le RhunDepartment of Medical Oncology and Hematology, Zurich University Hospital, Zurich, Switzerland (E.L.R.).
Paola QueiroloDivision of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IRCCS Ospedale Policlinico San Martino, Genova, Italy (P.Q.).
Guy JerusalemMedical Oncology Department, Centre Hospital Universitaire, Liege, Belgium (G.J.).
Erica L JohnstonEli Lilly and Company, Indianapolis, IN, USA (E.L.J.).
Pierfranco ConteDivision of Medical Oncology, University of Padova and Instituto Oncologico Veneto, Padova, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Abemaciclib is a selective cyclin-dependent kinase 4 and 6 inhibitor that penetrates the blood-brain barrier, resulting in comparable concentrations in tissue and plasma. The primary objective of this nonrandomized Simon two-stage phase II trial (NCT02308020) was to evaluate the intracranial objective response rate in patients with brain metastases secondary to breast cancer (already published), non-small cell lung cancer (NSCLC), or -melanoma receiving abemaciclib. Secondary objectives evaluated safety, extracranial response, progression-free survival (PFS), and overall survival (OS). Methods: Eligible subjects were enrolled in NSCLC or melanoma tumor-specific cohorts and treated with abemaciclib 200 mg twice daily (BID) monotherapy or 150 mg BID for NSCLC patients on concurrent pemetrexed or gemcitabine. Results: A total of 51 patients were enrolled (NSCLC, Conclusions: Although abemaciclib can achieve therapeutic concentrations in brain metastases tissue, this study did not meet its primary endpoint. The limited clinical activity in this study suggests that further clinical trials should focus on the use of abemaciclib combination therapy.

Indexed as

abemaciclibbrain metastasisphase II clinical trial

Identifiers

PMID41768125
PMCPMC12936396

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