Validation of prognostic and predictive value of total tumoral load after primary systemic therapy in breast cancer using OSNA assay

• Laia Bernet-Vegué ^[3] ; Carolina Cantero-González ^[1] ; Magdalena Sancho de Salas ^[2] ; David Parada ^[4] ; Tiziana Perin ^[5] ; Zulma Quintero-Niño ^[6] ; Begoña Vieites Pérez-Quintela ^[7] ; Douglas Sánchez-Guzmán ^[8] ; Marina Castelvetere ^[9] ; David Hardisson Hernaez ^[10] ; María Dolores Martín-Salvago ^[1]
  1. [1] Hospital Universitario de Jaén

     Hospital Universitario de Jaén

     Jaén, España

     
  2. [2] Hospital Universitario de Salamanca

     Hospital Universitario de Salamanca

     Salamanca, España

     
  3. [3] Breast Area, Department of Anatomic Pathology, Ribera Salud Hospitals, Valencia, Spain
  4. [4] Molecular Pathology Unit, Department of Pathology, Hospital Universitari de Sant Joan, Institut d’Investigació Sanitària Pere Virgili, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, Reus, Tarragona, Spain
  5. [5] Pathology Unit, Centro di Riferimento Oncologico di Aviano (C.R.O.), IRCCS, Aviano, Italy
  6. [6] Departamento de Anatomía Patológica, Hospital Universitario La Ribera, Alzira, Spain
  7. [7] Department of Pathology, University Hospital Virgen del Rocío, Seville, Spain
  8. [8] Pathology Department, Arnau de Vilanova University Hospital, Lleida, Spain
  9. [9] Pathological Anatomy Laboratory, Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy
  10. [10] Department of Pathology, Hospital Universitario La Paz, Molecular Pathology and Therapeutic Targets Group, Hospital La Paz Insitute of Research (IdiPAZ), Center for Biomedical Research in the Cancer Network (CIBERONC), Instituto de Salud Carlos III, Faculty of Medicine, Universidad Autónoma de Madrid, Madrid, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 26, Nº. 5, 2024, págs. 1220-1228
• Idioma: inglés
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• Resumen

  • Purpose This study aimed to validate the classification of breast cancer (BC) patients in progression risk groups based on total tumor load (TTL) value to predict lymph node (LN) affectation after neo-adjuvant systemic therapy (NAST) obtained in the NEOVATTL study.

    Methods/patients This was an observational, retrospective, international, multicenter study including patients with infiltrating BC who received NAST followed by sentinel lymph node biopsy (SLNB) analyzed with one-step nucleic acid amplification (OSNA) from nine Spanish and two Italian hospitals. Patients were classified into three groups according to the progression risk, measured as disease-free survival (DFS), based on TTL values (> 250, 250–25,000, and > 25,000 copies/μL). The previous (NEOVATTL study) Cox regression model for prognosis was validated using prognostic index (PI) and Log ratio test (LRT) analyses; the value of TTL for axillary non-SLN affectation was assessed using receiver operating characteristic (ROC) curves.

    Results We included 263 patients with a mean age of 51.4 (± SD 10.5) years. Patients with TTL > 25,000 copies/μL had a shorter DFS (HR 3.561 [95% CI 1.693−7.489], p = 0.0008 vs. TTL ≤ 25,000). PI and LRT analyses showed no differences between the two cohorts (p = 0.2553 and p = 0.226, respectively). ROC analysis showed concordance between TTL and non-SLN involvement (area under the curve 0.828), with 95.7% sensitivity and 92.9% specificity at a TTL cut-off of > 15,000 copies/μL.

    Conclusions In BC patients who had received NAST and underwent SLNB analysis using OSNA, a TTL value of > 25,000 copies/μL was associated with a higher progression risk and > 15,000 copies/μL was predictive of non-SLN involvement.