Evidence map›Paper›PMID 34109515›Full record

ArticleBreast cancer research and treatment2021

A phase I trial of sorafenib with whole brain radiotherapy (WBRT) in breast cancer patients with brain metastases and a correlative study of FLT-PET brain imaging.

Aki Morikawa, Milan Grkovski, Sujata Patil, Komal L Jhaveri, Kendrick Tang, John L Humm, Andrei Holodny, Kathryn Beal, Heiko Schöder, Andrew D Seidman

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT01621906 nacompletednot on this map

Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2012 to 2021Enrolled17ConditionsMetastatic Breast Cancer to the BrainArms18F-FLT-PET Imaging
NCT01724606 phase1completednot on this map

Whole Brain Radiotherapy (WBRT) With Sorafenib for Breast Cancer Brain Metastases (BCBM): A Phase I Study

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2012 to 2022Enrolled21ConditionsBreast Cancer, Brain MetastasesArmsWhole Brain Radiotherapy (WBRT), Sorafenib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Review
  3. The relationship between gadolinium enhancement and [18 F]fluorothymidine uptake in brain lesions with the use of hybrid PET/MRI.Cancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Article
  4. Review
  5. Article
  6. Review
  7. Comparison ofTomography (Ann Arbor, Mich.) · 2022
    Article
  8. Article
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 at 2 institutions in 1 country.

Aki MorikawaDivision of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Milan GrkovskiDepartment of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Sujata PatilDepartment of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Komal L JhaveriBreast Cancer Medicine Service, Evelyn Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th Street, New York, NY, 10065, USA.
Kendrick TangBreast Cancer Medicine Service, Evelyn Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th Street, New York, NY, 10065, USA.
John L HummDepartment of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Andrei HolodnyDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Kathryn BealDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Heiko SchöderDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Andrew D SeidmanBreast Cancer Medicine Service, Evelyn Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th Street, New York, NY, 10065, USA. seidmana@mskcc.org.ORCID http://orcid.org/0000-0002-5064-3966
Memorial Sloan Kettering Cancer Center · USUniversity of Michigan · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeSorafenib has demonstrated anti-tumor efficacy and radiosensitizing activity preclinically and in breast cancer. We examined sorafenib in combination with whole brain radiotherapy (WBRT) and explored the [18F] 3'deoxy-3'-fluorothymidine (FLT)-PET as a novel brain imaging modality in breast cancer brain metastases.

methodsA phase I trial of WBRT + sorafenib was conducted using a 3 + 3 design with safety-expansion cohort. Sorafenib was given daily at the start of WBRT for 21 days. The primary endpoints were to determine a maximum tolerated dose (MTD) and to evaluate safety and toxicity. The secondary endpoint was CNS progression-free survival (CNS-PFS). MacDonald Criteria were used for response assessment with a correlative serial FLT-PET imaging study.

results13 pts were evaluable for dose-limiting toxicity (DLT). DLTs were grade 4 increased lipase at 200 mg (n = 1) and grade 3 rash at 400 mg (n = 3). The MTD was 200 mg. The overall response rate was 71%. Median CNS-PFS was 12.8 months (95%CI: 6.7-NR). A total of 15 pts (10 WBRT + sorafenib and 5 WBRT) were enrolled in the FLT-PET study: baseline (n = 15), 7-10 days post WBRT (FU1, n = 14), and an additional 12 week (n = 9). A decline in average SUV

conclusionsConcurrent WBRT and sorafenib appear safe at 200 mg daily dose with clinical activity. CNS response was favorable compared to historical controls. This combination should be considered for further efficacy evaluation. FLT-PET may be useful as an early response imaging tool for brain metastases. TRIAL AND CLINICAL REGISTRY: Trial registration numbers and dates: NCT01724606 (November 12, 2012) and NCT01621906 (June 18, 2012).

Indexed as

Brain NeoplasmsBreast NeoplasmsBrainFemaleHumansNeuroimagingPositron-Emission TomographySorafenibSorafenibBrain metastasisBreast cancerFLT-PETSorafenibWhole brain radiotherapy

Identifiers

PMID34109515
PMCPMC11557212
OpenAlexW3169497610

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.