Evidence map›Paper›PMID 29153866›Full record

ArticleClinical breast cancer2018

A Phase I Trial of the PI3K Inhibitor Buparlisib Combined With Capecitabine in Patients With Metastatic Breast Cancer.

Autumn J McRee, Paul K Marcom, Dominic T Moore, William C Zamboni, Zachary A Kornblum, Zhiyuan Hu, Rachel Phipps, Carey K Anders, Katherine Reeder-Hayes, Lisa A Carey and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical breast cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Inhibitors targeting CDK4/6, PARP and PI3K in breast cancer: a review.Therapeutic advances in medical oncology · 2018
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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

13 authors.

Autumn J McReeLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC. Electronic address: autumn_mcree@med.unc.edu.
Paul K MarcomDuke Cancer Institute, Duke University Medical Center, Durham, NC.
Dominic T MooreLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
William C ZamboniLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Zachary A KornblumLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Zhiyuan HuLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Rachel PhippsLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Carey K AndersLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Katherine Reeder-HayesLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Lisa A CareyLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Karen E WeckLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Charles M PerouLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
E Claire DeesLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CHARLES M PEROU · 1992 to 2026
$59.3M
NCI NIH HHS P30 CA016086NCI NIH HHS P50 CA058223
6 · The paper itself

Abstract

backgroundBuparlisib is an oral pan-class I phosphotidyinositol-3-kinase (PI3K) inhibitor. The present phase I study evaluated the safety, pharmacokinetics, and efficacy of buparlisib with capecitabine in patients with metastatic breast cancer. PATIENTS AND

methodsPatients received buparlisib once daily (range, 50 to 100 mg) for 3 weeks with capecitabine twice daily (range, 1000 to 1250 mg/m

resultsOf the 25 patients enrolled, 23 were evaluable for DLT and 17 were evaluable for response. The maximum tolerated dose of the combination was buparlisib 100 mg daily and capecitabine 1000 mg/m

conclusionThe combination of buparlisib with capecitabine in patients with metastatic breast cancer was generally well-tolerated, with several patients demonstrating prolonged responses. Unexpectedly low rates of PIK3CA mutations (3 of 17) were seen, and only 2 of 7 tumors with subtyping were luminal, making exploration of these putative predictive markers impossible. Further study of the combination is not unreasonable, with expanded pharmacokinetics and sequencing analysis to better elucidate potential drug-drug interactions and more accurate predictive biomarkers of response.

Indexed as

AdultAminopyridinesAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaximum Tolerated DoseMiddle AgedMorpholinesMutationPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsAminopyridinesAntimetabolites, AntineoplasticCapecitabineMorpholinesNVP-BKM120Phosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsProtein Kinase InhibitorsBreast cancerBuparlisibCapecitabinePhase IPI3K

Identifiers

PMID29153866
PMCPMC5924643

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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.