Metadata supporting data files on "A case report of vanishing bile duct syndrome after exposure to pexidartinib (PLX3397) and paclitaxel"
Creators: name: Sorbarikor Piawah
name: Hyland, Colby
name: Umetsu, Sarah E.
name: Esserman, Laura J.
name: Rugo, Hope S.
name: A. Jo Chien
Publisher: name: figshare
Year: 2019
Subjects: subject: Cancer
subject: Medicine
subject: Pharmacology
subject: Biomarkers
subject: 111201 Cancer Cell Biology
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
subject: 111205 Chemotherapy
subject: 111502 Clinical Pharmacology and Therapeutics
subject: Diseases
subject: 110305 Emergency Medicine
subject: 110307 Gastroenterology and Hepatology
subject: 111299 Oncology and Carcinogenesis not elsewhere classified

description: This data record describes the data files that support the findings of the related publication: A case report of vanishing bile duct syndrome after exposure to pexidartinib (PLX3397) and paclitaxel.<b>Study design summary/description methodology:</b> This study is a case report, reporting a case of severe drug induced liver injury requiring liver transplantation due to vanishing bile duct syndrome (VBDS) after exposure to pexidartinib in the I-SPY 2 Trial, a phase 2 multicenter randomized neoadjuvant chemotherapy trial in patients with Stage II-III breast cancer. Pexidartinib (PLX3397) is a small molecule tyrosine kinase and colony stimulating factor-1 inhibitor with U.S. Food and Drug Administration (FDA) breakthrough therapy designation for tenosynovial giant cell tumor, and currently under study in several other tumor types including breast cancer. The patient in this case report is a postmenopausal woman diagnosed with a clinical stage 2B hormone receptor positive, HER2-negative left breast cancer. The patient was randomized to an investigational treatment arm including weekly intravenous paclitaxel (80 mg/m<sup>2</sup>) in combination with oral pexidartinib 1200 mg daily for 12 weeks. Blood and urine samples were collected and abdominal/pelvis CT scans and Magnetic resonance cholangiopancreatography (MRCP) were carried out on the patient. Multiple liver function tests (LFTs) were used to monitor the levels of bilirubin and transaminase enzymes and hence to monitor the patient’s liver function during the course of the study therapy. Abdominal ultrasound, hepatobillary scans, diagnostic endoscopic retrograde cholangio-pancreatography (ERCP) and liver biopsies were carried out. Staining of liver samples using copper and trichrome stains was used as an additional diagnostic tool for liver pathology. There are two data files described in this metadata record, one is in a <b>.jpg</b> format and the other in an <b>Excel</b> format. The two data files support figures 1 and 2 respectively, of the related manuscript. An additional dataset “<b>Various diagnostics</b>” is in the <b>EPIC</b> file format but this is not present in the related manuscript.<br> <b>Participant consent:</b> The patient is a 62-year-old postmenopausal woman diagnosed with a clinical stage 2B hormone receptor positive, HER2-negative left breast cancer. The patient provided written informed consent prior to screening and again prior to enrollment in the I-SPY 2 TRIAL, a trial testing agents in combination chemotherapy in the neoadjuvant setting in patients with early breast cancer. The trial was approved by the UCSF Institutional Review Board and written informed consent was obtained for publication of this case report.<br> <b>Data files:</b> The data file “<b>histology images</b>” supports figure 1 of the related manuscript. The figure consists of four histology images. A. Representative portal tract from the liver biopsy of the patient with absence of the interlobular bile duct. The hepatocytes show severe small droplet steatosis. This is a histologic specimen of human liver tissue stained with hematoxylin (violets) and eosin (reds) (x400 magnification). B. The image shows a histologic specimen of human liver tissue stained with hematoxylin (violets) and eosin (reds) (x40 magnification). The explant liver showed a biliary pattern of cirrhosis with extensive ductular reaction. This is evident by the increased number of hepatic ductules (the finest ramifications of the biliary tract) accompanied by polymorphonuclear leukocytes and an increase in matrix. C. A portal tract from the liver explant of the patient with absence of the interlobular bile duct and associated ductular reaction and cholestasis. This is a histologic specimen of human liver tissue stained with hematoxylin (violets) and eosin (reds) (x20 magnification). Ductular cholestasis is evident by the dilated ductules that also contain bile stained concernments (yellow-brown pigment). D. Histologic specimen of a normal portal tract from a liver biopsy, stained with hematoxylin (violets) and eosin (reds). The data file “<b>AST, ALT, Total bilirubin</b>” supports figure 2 of the related manuscript, consists of two graphs and describes the trends in hepatic enzymes and bilirubin levels in U/L of the patient from baseline through 6 months post-liver transplant. The x-axis in both graphs represents the time, in days, from the start of the treatment with intravenous paclitaxel in combination with oral pexidartinib (PLX3397) up to six months following liver transplantation. The y-axes in the first and second graphs show the concentration of hepatic enzymes, in U/L and the concentration of bilirubin in mg/dL, respectively. Colours blue, red, green and violet represent the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin (TBili), respectively.<br> <b>Data access and terms of use:</b>Given that this study was conducted using primary data derived from the patient’s medical record, this dataset is not publicly available in order to protect patient privacy. This is a limited access dataset that will be available upon reasonable request from the corresponding author. Access to the datasets that support the findings of the related manuscript will be provided only following the completion of a Data Usage Agreement. Requests for data access should be directed to Dr. Chien at the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco: A. Jo Chien, MD, Helen Diller Comprehensive Cancer Center University of California, San Francisco Box 1710, 1600 Divisadero, B637, San Francisco, CA 94115, U.S.A, email: Jo.Chien@ucsf.edu. <br>