Evidence map›Paper›PMID 32692450›Full record

Trial reportThe oncologist2020

Phase II Trial of Palbociclib in Patients with Advanced Esophageal or Gastric Cancer.

Thomas Benjamin Karasic, Mark H O'Hara, Ursina R Teitelbaum, Nevena Damjanov, Bruce J Giantonio, Tracy S d'Entremont, Maryann Gallagher, Paul J Zhang, Peter J O'Dwyer

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 5% 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

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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

9 authors at 2 institutions in 1 country.

Thomas Benjamin KarasicDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0001-9157-5392
Mark H O'HaraDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Ursina R TeitelbaumDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Nevena DamjanovDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Bruce J GiantonioDepartment of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Tracy S d'EntremontDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Maryann GallagherDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Paul J ZhangDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Peter J O'DwyerDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
University of Pennsylvania · USHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPalbociclib monotherapy demonstrated minimal clinical activity in patients with previously treated gastroesophageal cancers. Further clinical evaluation of palbociclib monotherapy is not warranted in gastroesophageal cancers, but improved understanding of resistance mechanisms may permit rational combination approaches.

backgroundDysregulation of the cell cycle is a hallmark of cancer. Progression through the G1/S transition requires phosphorylation of retinoblastoma (RB) by cyclin-dependent kinases (CDKs) 4 and 6, which are regulated by cyclins D and E. Amplifications of cyclin D loci and activating mutations in CDKs are frequent molecular aberrations in gastroesophageal malignancies. We conducted a phase II trial of the CDK4/6 inhibitor palbociclib as an initial test of efficacy.

methodsPatients with previously treated metastatic gastroesophageal cancers with intact RB nuclear expression by immunohistochemistry were treated with 125 mg daily of palbociclib for days 1-21 of 28-day cycles. The primary endpoint was overall response rate.

resultsWe screened 29 patients and enrolled 21 patients: 5 with gastric adenocarcinoma, 3 with gastroesophageal junction adenocarcinoma, 8 with esophageal adenocarcinoma, and 5 with esophageal squamous cell carcinoma. All 29 tumors screened had intact nuclear RB expression, and four treated patients tested positive for CCND1 overexpression. No objective responses were seen. Median progression-free survival was 1.8 months, and median overall survival was 3.0 months. All recurrent grade 3 or 4 toxicities were hematologic, with neutropenia in eight patients (38%), anemia in four patients (19%), and thrombocytopenia in two patients (10%).

conclusionPalbociclib has limited single-agent activity in gastroesophageal tumors.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansPiperazinesPyridinespalbociclibPiperazinesPyridines

Identifiers

PMID32692450
PMCPMC8108046
OpenAlexW3044880304

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.