147PD - First prospectively-designed outcome study in estrogen receptor (ER)+ breast cancer (BC) patients (pts) with N1mi or 1-3 positive nodes in whom tre...

Date 08 October 2016
Event ESMO 2016 Congress
Session Breast cancer, early
Topics Breast Cancer
Presenter Salomon Stemmer
Citation Annals of Oncology (2016) 27 (6): 43-67. 10.1093/annonc/mdw364
Authors S.M. Stemmer1, M. Steiner2, S. Rizel3, D. Geffen4, B. Nisenbaum5, T. Peretz6, L. Soussan-Gutman7, A. Bareket-Samish8, K. Isaacs9, O. Rosengarten10, G. Fried11, C. Svedman12, S. Shak12, N. Liebermann13, N. Ben-Baruch14
  • 1Davidoff Cancer Center, Rabin Medical Center and Sackler Faculty of Medicine, Tel Aviv University, 49414 - Petach Tikva/IL
  • 2Oncology Dept., LIN Medical Center, Haifa/IL
  • 3Davidoff Center, Rabin Medical Center, Petach Tikva/IL
  • 4Oncology, Soroka University Medical Center, 84101 - Beer Sheva/IL
  • 5Oncology, Meir Medical Center, Kfar Saba/IL
  • 6Sharett Institute Of Oncology, Hadassah Hebrew University Medical Center, Jerusalem/IL
  • 7Oncotest Division, Teva Pharmaceutical Industries, Ltd, Shoham/IL
  • 8Oncology, BioInsight Ltd, 30900 - Zichron Yaakov/IL
  • 9Oncology, Ha'emek Medical Center, Afula/IL
  • 10Oncology, Shaare Zedek Medical Center, Jerusalem/IL
  • 11Oncology, Rambam Health Care Campus, Haifa/IL
  • 12Research And Development, Genomic Health Inc, 94063 - Redwood City/US
  • 13Community Division, Clalit Health Services, Tel Aviv/IL
  • 14Oncology Department, Kaplan Medical Center, 76100 - Rehovot/IL



Recent outcome data including those from the prospective TAILORx trial strongly confirmed the RS role in node negative (N0) ER+ BC. The prospective WSG PlanB study showed excellent outcomes in high-risk N0 and node-positive (N+) pts with RS ≤ 11 and no adjuvant chemotherapy (CT). Physicians are increasingly using the RS for treatment decisions in N+ BC. We evaluated treatment and clinical outcomes in N+ pts undergoing RS testing through Clalit Health Services (CHS).


Medical records of all CHS pts with N+ ER+ HER2- BC who were tested between 1/2008 and 12/2011 were reviewed to verify treatment given and recurrence/death status. Interim results are presented herein. Final cohort results (>700 pts) will be presented at the meeting.


The current analysis includes 627 pts. Median age, 61 (34-87) yrs; 270 (43%) were N1mi, whereas 231 (37%) and 126 (20%) had 1 and 2-3, positive nodes, respectively. Grade 1 (15%), 2 (53%), 3 (16%), N/A (16%); histology, IDC (82%), lobular (12%), other (6%). With a median follow-up of 5.7 yrs, proportion of patients with distant recurrence (DR)/BC death by Paik et al and TAILORx RS categorization and by nodal status are presented in the Table. As pts were not randomized to treatment, analysis of DR/BC death by CT use is only exploratory: within the RS 18-30 group, CT-untreated pts (60%) had DR rate and BC death rate of 9.6% and 3.7%, respectively, whereas in CT-treated pts (40%) these rates were 2.2% and 1.1%; within the RS 11-25 group, CT-untreated pts (82%) had DR rate and BC death rate of 4.1% and 1.2%, respectively, whereas in CT-treated pts (18%) these rates were 2.7% and 0%.

CT use, % DR rate, % BC death rate, %
Paik et al RS categorization


CT use was aligned with the RS results. Pts with N1mi or 1-3 positive nodes and RS ≤ 25 had very good outcomes, even when selected for endocrine therapy alone. Updated data will be presented at the meeting.

Clinical trial identification

Trial protocol number: 0075-14-COM

Legal entity responsible for the study

Dr. Stemmer is the sponsor-investigator responsible for all aspects of the study including design and conduct of the study, collection, analysis and interpretation of the data, and preparation of the manuscript.


Funded through grant from Teva Pharmaceuticals Ltd.


S.M. Stemmer: Received grant funding from Teva and travel expenses from Genomic Health. L. Soussan-Gutman: Teva employee. Holds stock options for Teva Pharmaceuticals Ltd. A. Bareket-Samish: Consultant for Teva Pharmaceutical Industries and Genomic Health, Inc. O. Rosengarten: Received payments for lectures and grants for traveling from Teva Pharmaceuticals. C. Svedman, S. Shak: Genomic Health employee. Holds stock options for Genomic Health. N. Ben-Baruch: Serves on Genomic Health's speakers bureau. All other authors have declared no conflicts of interest.