TY - JOUR
T1 - Rapid, real time pathology review for ECOG/ACRIN 1412
T2 - A novel and successful paradigm for future lymphoma clinical trials in the precision medicine era
AU - King, Rebecca L.
AU - Nowakowski, Grzegorz S.
AU - Witzig, Thomas E.
AU - Scott, David W.
AU - Little, Richard F.
AU - Hong, Fangxin
AU - Gascoyne, Randy D.
AU - Kahl, Brad S.
AU - Macon, William R.
N1 - Funding Information:
This study was coordinated by the ECOG-ACRIN Cancer Research Group (Peter J. O’Dwywer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA180794, CA180790, CA180799, CA180833. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.Clinical Trial #: NCT01856192 1Mayo Clinic, Rochester, MN, USA. 2British Columbia Cancer Agency, Vancouver, BC, Canada. 3Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA. 4Dana-Farber Cancer Institute, Harvard T.H. Chan School of Public Health, Boston, USA. 5Washington University School of Medicine, St. Louis, MO, USA
Funding Information:
G.S.N., MD: Celgene, Roche, Bayer, MorphoSys and Nanostring-Consulting (no personal compensation, money to Mayo): Celgene, Bayer, MorphoSys, AbbVie, Pharmacyclics, and Roche. D.W.S., MBChB, PhD: Consultant for Celgene. Inventor on a patent: “Methods for selecting and treating lymphoma types.” (Institution). B.S.K., MD: Performed consulting for Genentech and Celgene and receives research funding from Genentech and Celgene. The remaining authors declare that they have no conflict of interest.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/3/1
Y1 - 2018/3/1
N2 - 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.
AB - 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.
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U2 - 10.1038/s41408-018-0064-9
DO - 10.1038/s41408-018-0064-9
M3 - Review article
C2 - 29531316
AN - SCOPUS:85044220249
SN - 2044-5385
VL - 8
JO - Blood cancer journal
JF - Blood cancer journal
IS - 3
M1 - 27
ER -