Rapid, real time pathology review for ECOG/ACRIN 1412: A novel and successful paradigm for future lymphoma clinical trials in the precision medicine era

Rebecca L. King, Grzegorz S. Nowakowski, Thomas E. Witzig, David W. Scott, Richard F. Little, Fangxin Hong, Randy D. Gascoyne, Brad S. Kahl, William R. Macon

Research output: Contribution to journalReview article

5 Scopus citations

Abstract

ECOG/ACRIN 1412 (E1412) is a randomized, phase II open-label study of lenalidomide/RCHOP vs. RCHOP alone in adults with newly diagnosed de novo diffuse large B-cell lymphoma (DLBCL) and requires NanoString gene expression profiling (GEP) for cell-of-origin testing. Because of high ineligibility rate on retrospective expert central pathology review (ECPR), real-time (RT) ECPR was instituted to confirm diagnosis and ensure adequate tissue for GEP prior to study enrollment. Goal was notification of eligibility within 2 working days (WD). Initially, 208 patients were enrolled, 74 (35.6%) of whom were deemed ineligible by retrospective ECPR. After initiation of RT-ECPR, 219 patients were registered. Of these, 73 (33.3%) were ineligible and were declined enrollment; 47 (21.5% of total) had an ineligible diagnosis on RT-ECPR, and 26 (11.9% of total) had inadequate tissue. Because the 73 ineligible patients were never enrolled, no study slots were "lost" during this phase. Notification of eligibility occurred in an average of 1 WD (Range 0-4) with 97.3% within 2 WD. This novel RT-ECPR serves as a model for future lymphoma trials. Real-time ECPR can help to reduce costs and ensure that study slots accurately reflect the targeted population. In the precision-medicine era, rapid collection of relevant pathology/biomarker data is essential to trial success.

Original languageEnglish (US)
Article number27
JournalBlood cancer journal
Volume8
Issue number3
DOIs
StatePublished - Mar 1 2018

ASJC Scopus subject areas

  • Hematology
  • Oncology

Fingerprint Dive into the research topics of 'Rapid, real time pathology review for ECOG/ACRIN 1412: A novel and successful paradigm for future lymphoma clinical trials in the precision medicine era'. Together they form a unique fingerprint.

  • Cite this