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

The Swiss Group for Clinical Cancer Research (SAKK)¹  Thomas Ruhstaller²  Christoph Rageth³  Christoph Tausch³  Katharina Buser⁴  Stefan Zimmermann⁵  Urban Novak⁶  Bettina Seifert⁷  Roger von Moos⁸  Catrina Uhlmann Nussbaum⁹  Andreas Mueller^1,10  Stefan Aebi^1,11  Ralph Winterhalder^1,11  Martin Bigler^1,12  Vincent Bize^1,12  Simona Berardi Vilei^1,12  Markus Borner^1,13  Christoph Rochlitz^1,14  Konstantin J. Dedes^1,15  Bernhard C. Pestalozzi^1,15 

[1] ;Breast Center St. Gallen;Brustzentrum Zuerich;Engeriedspital Bern;Hôpital Cantonal Fribourg;Inselspital Bern;Kantonsspital Baselland;Kantonsspital Graubuenden Chur;Kantonsspital Olten;Kantonsspital Winterthur;Luzerner Kantonsspital;SAKK Coordinating Center;Spitalzentrum Biel;Universitaetsspital Basel;Universitaetsspital Zuerich;

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

DOI  :  10.1186/s12885-017-3261-1

来源: DOAJ

【 摘 要 】

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

【 授权许可】

Unknown