Evidence map›Paper›PMID 35314693›Full record

ArticleNPJ breast cancer2022

A phase II trial of an alternative schedule of palbociclib and embedded serum TK1 analysis.

Jairam Krishnamurthy, Jingqin Luo, Rama Suresh, Foluso Ademuyiwa, Caron Rigden, Timothy Rearden, Katherine Clifton, Katherine Weilbaecher, Ashley Frith, Anna Roshal and 9 more

Open access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.6field-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.

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, 20 citations in OpenAlex.

  1. Trial
  2. Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226).Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals · 2023
    Trial
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  6. Observational
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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

19 authors at 4 institutions in 2 countries.

Jairam KrishnamurthyDivision of Oncology/Hematology, University of Nebraska Medical Center, Omaha, NE, USA. Jairam.Krishnamurthy@unmc.edu.ORCID http://orcid.org/0000-0003-0939-4184
Jingqin LuoDivision of Public Health Science, Department of Surgery, Siteman Cancer Center, Biostatistics Shared Resource, Washington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0003-2759-3072
Rama SureshDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Foluso AdemuyiwaDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-6766-2258
Caron RigdenDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Timothy ReardenDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Katherine CliftonDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Katherine WeilbaecherDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Ashley FrithDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Anna RoshalDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Pavan K TandraDivision of Oncology/Hematology, University of Nebraska Medical Center, Omaha, NE, USA.ORCID http://orcid.org/0000-0001-5271-3748
Mathew CherianDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Tracy SummaDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Brittney HaasDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Shana ThomasDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Leonel Hernandez-AyaDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Mattias BergqvistBiovica International AB, Uppsala, Sweden.ORCID http://orcid.org/0000-0002-0093-9443
Lindsey PetersonDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Cynthia X MaDivison of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA. cynthiaxma@wustl.edu.ORCID http://orcid.org/0000-0002-8156-7492
Washington University in St. Louis · USBiovica (Sweden) · SENebraska Medical Center · USUniversity of Nebraska Medical Center · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI TIMOTHY J. EBERLEIN · 2001 to 2026
$128.0M
NCI NIH HHS P30 CA091842
6 · The paper itself

Abstract

Palbociclib 3-weeks-on/1-week-off, combined with hormonal therapy, is approved for hormone receptor positive (HR+)/HER2-negative (HER2-) advanced/metastatic breast cancer (MBC). Neutropenia is the most frequent adverse event (AE). We aim to determine whether an alternative 5-days-on/2-days-off weekly schedule reduces grade 3 and above neutropenia (G3 + ANC) incidence. In this single-arm phase II trial, patients with HR+/HER2- MBC received palbociclib 125 mg, 5-days-on/2-days-off, plus letrozole or fulvestrant per physician, on a 28-day cycle (C), as their first- or second-line treatment. The primary endpoint was G3 + ANC in the first 29 days (C1). Secondary endpoints included AEs, efficacy, and serum thymidine kinase 1 (sTK1) activity. At data-cutoff, fifty-four patients received a median of 13 cycles (range 2.6-43.5). The rate of G3 + ANC was 21.3% (95% CI: 11.2-36.1%) without G4 in C1, and 40.7% (95% CI: 27.9-54.9%), including 38.9% G3 and 1.8% G4, in all cycles. The clinical benefit rate was 80.4% (95% CI: 66.5-89.7%). The median progression-free survival (mPFS) (95% CI) was 19.75 (12.11-34.89), 33.5 (17.25-not reached [NR]), and 11.96 (10.43-NR) months, in the overall, endocrine sensitive or resistant population, respectively. High sTK1 at baseline, C1 day 15 (C1D15), and C2D1 were independently prognostic for shorter PFS (p = 9.91 × 10

Identifiers

PMID35314693
PMCPMC8938484
OpenAlexW4220931985

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Registered trials

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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.