Adjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10).

Pestalozzi, Bernhard C; Tausch, Christoph; Dedes, Konstantin J; Rochlitz, Christoph; Zimmermann, Stefan; von Moos, Roger; Winterhalder, Ralph; Ruhstaller, Thomas; Mueller, Andreas; Buser, Katharina; Borner, Markus; Novak, Urban; Nussbaum, Catrina Uhlmann; Seifert, Bettina; Bigler, Martin; Bize, Vincent; Vilei, Simona Berardi; Rageth, Christoph; Aebi, Stefan (2017). Adjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10). BMC cancer, 17(1), p. 265. BioMed Central 10.1186/s12885-017-3261-1

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To evaluate the effect of Recurrence Score® results (RS; Oncotype DX® multigene assay ODX) on treatment recommendations by Swiss multidisciplinary tumor boards (TB).


SAKK 26/10 is a multicenter, prospective cohort study of early breast cancer patients: Eligibility: R0-resection, ≥10% ER+ malignant cells, HER2-, pN0/pN1a. Patients were stratified into low-risk (LR) and non-low-risk (NLR) groups based on involved nodes (0 vs 1-3) and five additional predefined risk factors. Recommendations were classified as hormonal therapy (HT) or chemotherapy plus HT (CT + HT). Investigators were blinded to the statistical analysis plan. A 5%/10% rate of recommendation change in LR/NLR groups, respectively, was assumed independently of RS (null hypotheses).


Two hundred twenty two evaluable patients from 18 centers had TB recommendations before and after consideration of the RS result. A recommendation change occurred in 45 patients (23/154 (15%, 95% CI 10-22%) in the LR group and 22/68 (32%, 95% CI 22-45%) in the NLR group). In both groups the null hypothesis could be rejected (both p < 0.001). Specifically, in the LR group, only 5/113 (4%, 95% CI 1-10%) with HT had a recommendation change to CT + HT after consideration of the RS, while 18/41 (44%, 95% CI 28-60%) of patients initially recommended CT + HT were subsequently recommended only HT. In the NLR group, 3/19 (16%, 95% CI 3-40%) patients were changed from HT to CT + HT, while 19/48 (40%, 95% CI 26-55%) were changed from CT + HT to HT.


There was a significant impact of using the RS in the LR and the NLR group but only 4% of LR patients initially considered for HT had a recommendation change (RC); therefore these patients could forgo ODX testing. A RC was more likely for NLR patients considered for HT. Patients considered for HT + CT have the highest likelihood of a RC based on RS.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Borner, Markus and Novak, Urban


600 Technology > 610 Medicine & health




BioMed Central




Nicole Corminboeuf

Date Deposited:

22 Mar 2018 09:44

Last Modified:

24 Oct 2019 15:09

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Adjuvant treatment recommendation ER-positive early breast cancer Multigene expression profiling Oncotype DX Recurrence score




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