282P - Prospective evaluation of two multi-gene assays in node-negative, estrogen receptor-positive (ER+) breast cancer patients to aid adjuvant clinical...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Breast Cancer, Early Stage
Biomarkers
Presenter EDUARDO Martinez de Dueñas
Citation Annals of Oncology (2014) 25 (suppl_4): iv85-iv109. 10.1093/annonc/mdu327
Authors E. Martinez de Dueñas1, A. Lluch-Hernandez2, A. Llombart Cussac3, A. Rodriguez-Lescure4, D. Salas5, J. Miranda GarcÍa5
  • 1Medical Oncology, HOSPITAL PROVINCIAL DE CASTELLÓN, 12002 - CASTELLON/ES
  • 2Serv. Hematologia Y Oncologia Medica, Hospital Clinico Universitario de Valencia, ES-46010 - Valencia/ES
  • 3Medical Oncology Service, Hospital Arnau de Vilanova, Valencia/ES
  • 4Medical Oncology, Hospital Universitario de Elche, Elche/ES
  • 5Dirección General De Salud Pública, Conselleria de Sanitat, 46020 - Valencia/ES

Abstract

Aim

Gene expression profiles have prognostic value and have led to altered adjuvant systemic therapy recommendations in 25%–30% of breast cancer patients. We prospectively evaluated the effect of two multi-gene assays on adjuvant systemic treatment decisions in a Spanish autonomous community.

Methods

Enrollment was offered to women <75 years with hormone receptors-positive /HER2-negative operable breast cancer with micrometastases or negative lymph nodes (pT1-2 pN0-N1mi M0) and who met at least one of the following criteria: 1) weak immunostaining of ER (10-60%); 2) negative PR (<10%); 3) histological grade 2; and/or 4) intermediate Ki-67 (13-30%). Oncologists recorded treatment recommendation before and after performing one of these two genomic expression profiles: Recurrence Score or 70-gene prognosis signature, depending on the allocated health department.

Results

Of 283 eligible patients, the 70-gene signature was performed in 176 patients (118 [67%] with low-risk and 58 [33%] with high-risk); and the Recurrence Score (RS) was assessed in 75 patients (44 [59%] with low-risk, 21 [28%] intermediate- and 10 [13%] with high-risk). Treatment recommendation changed in 62% of patients assessed by the 70-gene signature (50% from chemohormonal [CHT] to hormonal therapy [HT] alone, and 12% from HT to CHT), and in 64% of patients assessed by the RS (55% from CHT to HT and 9% from HT to CHT), for an overall change of 63%. The change in the therapeutic recommendation was more common in the group of patients previously advised for CTH than in the group advised for HT alone, both in the 70-gene signature (69% vs. 44%; p = 0.0018) and in the RS (68% vs. 47%; p = 0.1179).

Conclusions

In this community-based study, prognostic multi-gene assays allowed avoiding chemotherapy to a larger proportion of patients than previously reported.

Disclosure

All authors have declared no conflicts of interest.