Metadata supporting the article: Precision Medicine: Preliminary Results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT 2) Study
Creators: name: Tsimberidou, Apostolia Maria
name: Hong, David S.
name: Fu, Siqing
name: Karp, Daniel D.
name: Piha-Paul, Sarina
name: Kies, Merrill S.
name: Ravi, Vinod
name: Subbiah, Vivek
name: Patel, Sunil M.
name: Tu, Shi-Ming
name: Janku, Filip
name: Heymach, John
name: Johnson, Amber
name: Cartwright, Carrie
name: Zhao, Li
name: Zhang, Jianhua
name: Berry, Donald A.
name: Vining, David J
name: Futreal, Andrew
name: Miller, Vincent A.
name: Meric-Bernstam, Funda
Publisher: name: figshare
Year: 2021
Subjects: Biological Techniques
Cancer
Biological Sciences not elsewhere classified
Medicine
Cancer Cell Biology
Cancer Genetics
Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
Chemotherapy

description: Precision medicine is associated with favorable outcomes in selected patients with cancer. In this study, the authors report an interim analysis of IMPACT2, an ongoing randomized study evaluating genomic profiling and targeted agents in metastatic cancer. The primary objective of the study was to determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) from the time of randomization than those whose treatment is not selected on the basis of alteration analysis. In this preliminary analysis, authors describe the results of molecular profiling of 320 patients who participated in the first part of the study and assessed the association between overall survival (OS) and patient characteristics and molecular alterations.<br><b>Data access</b>: The next-generation sequencing data generated during the study, are available in the European Genome-phenome Archive (EGA) (data are subject to controlled-access): <b>https://identifiers.org/ega.dataset:EGAD00001006887</b> (dataset ID) and <b>https://identifiers.org/ega.study:EGAS00001004964</b> (study ID). Dataset IMPACT2_supporting_data.xlsx, supporting figure 4, tables 1 and 2, supplementary tables 1-3 and supplementary figures 2-10, is part of the supplementary files that accompany the article.Please contact the corresponding author for data inquiries:Dr. Apostolia-Maria Tsimberidou Professor of Medicine Investigational Cancer Therapeutics (ICT) UT MD Anderson Cancer Center1515 Holcombe Boulevard, Box 455Houston, Texas 77030-4009E: <b>atsimber@mdanderson.org</b><br><b>Clinical trial registration number</b>: The study was registered in www.clinicaltrials.gov (NCT02152254)<br><b>Study approval and patient consent</b>: This study was approved by the University of Texas MD Anderson Cancer Center Institutional Review Board IRB1 (Registration #IRB00000121 - Clinical). All patients signed informed consent forms stating that they were aware of the investigational nature of the study.<br><b>Study aims and methodology</b>: In 2007, the authors of the study, initiated the first personalized medicine oncology program across tumor types, Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT), to explore whether in patients with advanced metastatic cancer, the use of investigational agents matched with patient tumor molecular alterations would improve treatment outcomes compared to investigational agents not matched with patient tumor alterations. IMPACT2 was initiated after the first IMPACT study, with the aim of assessing the personalized medicine approach in a randomized study across tumor types using adoptive design to overcome the limitations of IMPACT.From May 2014 to April 2017, 391 patients were enrolled in the first part of the study, and 320 patients (81.84%) had detectable molecular abnormalities in their tumors. Seven patients had no abnormalities on tumor molecular testing. The remaining patients had inadequate tumor cells for analysis (n = 19), disease that was non-measurable/biopsy was not feasible (n = 15), withdrew consent (n = 12), had worsening performance status (PS) (n = 8), had no evidence of cancer (n = 2), were lost to follow-up (n = 2), had two tumor types (n = 1), or were ineligible for logistic reasons (n = 5). Overall, 69 of the 320 patients were randomized.The following are described in more detail in the methodology of the published article: patient eligibility criteria, tumor molecular profiling, next-generation sequencing, treatment, exploratory analysis, variant annotation and pathway analysis, tumor mutational burden analysis and statistical methods.<br><b>Data supporting the findings of the study: </b>Data supporting figures 2 and 3, and supplementary figure 1: <b>Next-generation sequencing data</b> (controlled-access), available in EGA: <b>https://identifiers.org/ega.dataset:EGAD00001006887 </b>(dataset ID) and <b>https://identifiers.org/ega.study:EGAS00001004964</b> (study ID). The EGA data record includes 320 .<b>bam files</b>, in .bam file format.<br>Data supporting figure 4, tables 1 and 2, supplementary tables 1-3 and supplementary figures 2-10: Dataset <b>IMPACT2_supporting_data.xlsx</b>, in .xlsx file format, and contains de-identified data from 320 patients involved in the study. The dataset is publicly available as part of the supplementary files that accompany the article.<br><b>Data supporting supplementary table 4</b>: FoundationOne CDx™ panel, in .pdf file format (<b>https://assets.ctfassets.net/w98cd481qyp0/YqqKHaqQmFeqc5ueQk48w/0a34fcdaa3a71dbe460cdcb01cebe8ad/F1CDx_Technical_Specifications_072020.pdf</b>). The file was accessed from https://www.foundationmedicine.com/. <br>