03 Mar Genetic Assay Oncotype Dx Helps Clarify Chemotherapy Decisions in HER2 Negative Breast Cancer
MedicalResearch.com Interview with:
Oleg Gluz, MD
West German Study Group
Breast Center Niederrhein
Evangelical Hospital Bethesda
MedicalResearch.com: What is the background for this study?
Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients.
For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk.
MedicalResearch.com: What are the main findings?
Dr. Gluz: The study has two major findings:
We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67).
Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Gluz: We should be very careful to indicate chemotherapy based on only one single prognostic factor alone (e.g. grade 3, one positive lymph node or high Recurrence Score) due to significant assessment discordance between different prognostic tools (most of them are independent prognostic markers).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Gluz: Excellent outcome in patients within highly heterogeneous intermediate risk group (RS 12-25) all treated by chemotherapy indicates a clear overtreatment in this group. Results of our (WSG-ADAPT) and other (TAILORx, RxPONDER) ongoing studies are anticipated prior to final conclusions on optimal treatment in this group can be had.
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West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment
Oleg Gluz, Ulrike A. Nitz, Matthias Christgen, Ronald E. Kates, Steven Shak,Michael Clemens, Stefan Kraemer, Bahriye Aktas, Sherko Kuemmel, Toralf Reimer,Manfred Kusche, Volker Heyl, Fatemeh Lorenz-Salehi, Marianne Just, Daniel Hofmann,Tom Degenhardt, Cornelia Liedtke, Christer Svedman, Rachel Wuerstlein,Hans H. Kreipe, and Nadia Harbeck
JCO JCO635383; published online on February 29, 2016;
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Dr. Oleg Gluz (2016). Genetic Assay Oncotype Dx Helps Clarify Chemotherapy Decisions in HER2 Negative Breast Cancer