Browsing by Author "Sanfeliu, E."

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    HER2DX in HER2-positive inflammatory breast cancer: correlative insights and comparative analysis with noninflammatory breast cancers
    (HUMANA PRESS INC, 2025) Lynce, F.; Martinez-Saez, O.; Walbaum Garcia, Benjamin Vicente; Braso-Maristany, F.; Waks, A.G.; Villagrasa, P.; Villacampa, Javierre G.; Sanfeliu, E.; Galvan, P.; Pare, L.; Anderson, L.M.; Perou, C.M.; Parker, J.S.; Vivancos, A.; DiLullo, M.K.; Pernas, S.; Winer, E.P.; Overmoyer, B.; Mittendorf, E.A.; Bueno-Muino, C.; Martin, M.; Prat, A.; Tolaney, S.M.
    The HER2DX assay predicts long-term prognosis and pathologic complete response (pCR) in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving neoadjuvant systemic therapy but has not been evaluated in inflammatory breast cancer (IBC). Patients and methods: HER2DX was analyzed in baseline biopsy tissues from 23 patients with stage III HER2-positive IBC on a phase II trial (NCT01796197) treated with neoadjuvant trastuzumab, pertuzumab, and paclitaxel (THP). To assess the assay's predictive accuracy for pCR in IBC, clinical-pathological features and outcomes from this IBC cohort were compared with 156 patients with stage III HER2-positive non-IBC from four different cohorts. Comparative analyses included HER2DX scores, gene signatures, and expression of individual genes between patients with IBC and non-IBC. Results: Notable differences in clinicopathological characteristics included higher pertuzumab and chemotherapy usage and lower axillary burden in patients with IBC compared with non-IBC. In the combined cohort (n = 179), HER2DX pCR score and pertuzumab use were significant predictors of pCR, but not IBC status. The pCR rates in patients treated with trastuzumab-based chemotherapy (including IBC and non-IBC) were 68.9%, 58.5%, and 16.3% in the HER2DX pCR-high, -medium, and -low groups, respectively. Comparative gene expression analysis indicated minor differences between IBC and non-IBC affecting individual HER2, immune, and proliferation genes. Conclusions: The HER2DX pCR score could predict pCR in stage III HER2-positive IBC following treatment with de-escalated neoadjuvant systemic therapy and in stage III HER2-positive non-IBC. Elevated pCR rates in HER2-positive IBC with high HER2DX pCR scores suggest there may be a role for treatment de-escalation in these patients and confirmatory studies are justified.
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    HER2DX in HER2-positive inflammatory breast cancer: correlative insights and comparative analysis with noninflammatory breast cancers
    (2025) Lynce, F.; Martinez-Saez, O.; Walbaum Garcia, Benjamin Vicente; Braso-Maristany, F.; Waks, A.G.; Villagrasa, P.; Villacampa, Javierre G.; Sanfeliu, E.; Galvan, P.; Pare, L.; Anderson, L.M.; Perou, C.M.; Parker, J.S.; Vivancos, A.; DiLullo, M.K.; Pernas, S.; Winer, E.P.; Overmoyer, B.; Mittendorf, E.A.; Bueno-Muino, C.; Martin, M.; Prat, A.; Tolaney, S.M.
    The HER2DX assay predicts long-term prognosis and pathologic complete response (pCR) in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving neoadjuvant systemic therapy but has not been evaluated in inflammatory breast cancer (IBC). Patients and methods: HER2DX was analyzed in baseline biopsy tissues from 23 patients with stage III HER2-positive IBC on a phase II trial (NCT01796197) treated with neoadjuvant trastuzumab, pertuzumab, and paclitaxel (THP). To assess the assay's predictive accuracy for pCR in IBC, clinical-pathological features and outcomes from this IBC cohort were compared with 156 patients with stage III HER2-positive non-IBC from four different cohorts. Comparative analyses included HER2DX scores, gene signatures, and expression of individual genes between patients with IBC and non-IBC. Results: Notable differences in clinicopathological characteristics included higher pertuzumab and chemotherapy usage and lower axillary burden in patients with IBC compared with non-IBC. In the combined cohort (n = 179), HER2DX pCR score and pertuzumab use were significant predictors of pCR, but not IBC status. The pCR rates in patients treated with trastuzumab-based chemotherapy (including IBC and non-IBC) were 68.9%, 58.5%, and 16.3% in the HER2DX pCR-high, -medium, and -low groups, respectively. Comparative gene expression analysis indicated minor differences between IBC and non-IBC affecting individual HER2, immune, and proliferation genes. Conclusions: The HER2DX pCR score could predict pCR in stage III HER2-positive IBC following treatment with de-escalated neoadjuvant systemic therapy and in stage III HER2-positive non-IBC. Elevated pCR rates in HER2-positive IBC with high HER2DX pCR scores suggest there may be a role for treatment de-escalation in these patients and confirmatory studies are justified.
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    Ki67 dynamic predicts endocrine sensitivity in estrogen receptor-positive/ HER2-negative breast cancer patients undergoing preoperative endocrine therapy
    (2025) Gómez-Bravo, R.; Walbaum, B.; Bergamino, M.; Martínez-Sáez, O.; Schettini, F.; Seguí, E.; García-Fructuoso, I.; Pascual, T.; Chic, N.; González, M.; Rodríguez, A.; Rey, M.; Giménez-Xavier, P.; Blasco, P.; Castillo, O.; Galván, P.; Sanfeliu, E.; González-Farré, B.; Vidal, M.; Adamo, B.; Brasó-Maristany, F.; Prat, A.; Muñoz, M.
    Background: Early decrease in Ki67 after a short preoperative course of endocrine therapy (ET) has shown prognostic and predictive value in clinical research, but its applicability and reproducibility in routine clinical practice remain largely unknown. We therefore assessed on-treatment Ki67 changes following a short preoperative ET and its association with biological variables, such as intrinsic subtype and risk of recurrence (ROR), plus long-term outcomes, in a real-world cohort of patients with early estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-negative) breast cancer. Methods: We conducted a retrospective, registry-based analysis of 230 consecutive patients with early ER+/HER2− breast cancer treated as per standard clinical care at the Breast Unit of the Clinic Barcelona Comprehensive Cancer Center between 2014 and 2023. All patients received preoperative ET, tamoxifen, or an aromatase inhibitor (AI), for 2-12 weeks before surgery. Clinical and pathological variables were collected and stratified by Ki67 response: “responders” (post-treatment Ki67 0% to 10%) and “complete cell cycle arrest (CCCA) responders” (Ki67 ≤2.7%). PAM50/Prosigna was used to determine intrinsic subtypes and ROR-score. Event-free survival was estimated using Kaplan—Meier curves, and associations were tested using Cox proportional hazards regression. Results: The median duration of preoperative ET was 5 weeks (min-max range, 2-12 weeks). Overall, 196 patients (85.2%) met the Ki67 response criterion and 111 (48.3%) achieved CCCA. Response rates were significantly higher in postmenopausal compared with premenopausal women (P = 0.004). Notably, 95.6% of postmenopausal patients received an AI, whereas all premenopausal women were treated with tamoxifen. Additionally, response varied by intrinsic subtype, favoring Luminal A tumors (P = 0.047). In multivariable models, postmenopausal status and higher baseline ER expression were independently associated with both Ki67 response and CCCA, whereas a lower baseline ROR-score predicted CCCA. After a median follow-up of 47 months, CCCA was associated with significantly improved event-free survival [hazard ratio (HR) = 0.19; 95% CI (confidence interval) 0.05-0.72; P value = 0.012]. Conclusion: In routine practice, a short course of preoperative ET yields substantial reductions in tumor proliferation. Early assessment of Ki67 suppression offers a readily accessible indicator of endocrine sensitivity, and achieving CCCA identifies patients who have a more favorable prognosis and thus are potentially eligible to de-escalate in treatment strategies.