No abstract

Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast- conserving surgery (BCS) rates, provides an opportunity for us to assess in vivo NET effectiveness, and allows us to study any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the safety and effectiveness of NET, and to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From 2016 to 2020, a single-institution cohort of patients, treated with NET and further surgery, was evaluated. In patients with Ki67 ≥ 10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes was gathered. Results: A total of 115 estrogen receptor-positive (ER+)/HER2-negative patients were included. The median treatment duration was 5.0 months (IQR: 2.0–6.0). The median maximum size in the surgical sample was 40% smaller than the pretreatment size measured by ultrasound (p < 0.0001). The median pretreatment Ki67 expression was 20.0% (IQR: 12.0–30.0), and was reduced to 5.0% (IQR: 1.8–10.0) after four weeks, and to 2.0% (IQR: 1.0–8.0) in the surgical sample (p < 0.0001). BCS was performed on 98 patients (85.2%). No pathological complete responses were recorded. A larger Ki67 fold change after four weeks was significantly related to a PEPI score of zero (p < 0.002). No differences were observed between luminal A- and B-like tumors, with regard to fold change and PEPI score. Conclusions: In our cohort, NET was proven to be effective for tumor size and Ki67 downstaging. This resulted in a higher rate of conservative surgery, aided in therapeutic decision making, provided prognostic information, and constituted a safe and well-tolerated approach.

Purpose To evaluate the reversibility of the clinical and histological changes induced in the corneas of an animal model after removing intracorneal ring segment (ICRS). Methods We performed surgery for this study in 30 eyes (15 hens) of an experimental animal model of ICRS surgery(Ferrara technique) previously described by us. The animals were randomized in 5 groups, in all of them, we implanted one segment in each eye and was removed in 3 months. Each Group was processed at different time points for clinical and histological analysis,7 days (first group)15 days (second group), 1 month (third group), 2 months (fourth group), and 3 months( fifth group). For histological analysis hematoxilin eosine and Masson Trichromic stains were made. Clinical evaluation was made with a surgical microscope. Results Explantation was performed correctly in all cases, no complications were found. Histological analysis:At 7 days we observed hipercelularity and abnormal conformation of the collagen fibres, which at 15 days change to normal, with persistente of the hipercelularity.Later, at 3 months the hipercelularity decreased to normal values similar to preoperative. As regards clinical evaluation:in the first weeks we observed deposits of cells and a moderate degree of corneal opacity( haze) around the space where the ICRS was implanted, signs which decreased progressively. At 3 months neither deposits of cells nor corneal opacity were found. Conclusion ICRS are safety explanted from non‐pathologic corneas of an experimental animal model.Most of the clinical and histological findings returned to near preimplantation levels.

Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast conserving surgery (BCS) rates and provides an opportunity for assessing in vivo NET effectiveness and studying any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the effectiveness of NET as well as to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From June 2016 to January 2022, a single-institution cohort of patients treated with NET and further surgery was evaluated. In patients with Ki67≥10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes, as well as surgical management, was gathered. Results: A total of 168 estrogen receptor positive (ER+)/HER2 negative patients were included. The median age at diagnosis was 69.5 years old (IQR: 16.0). The median treatment duration was 5.0 months (IQR: 4.0). Median maximum size in the surgical sample was 44.0% smaller than pretreatment size measured by ultrasound (p&lt;.0001), showing an inverse linear relationship with treatment duration. Median pretreatment Ki67 expression was 20.0% (IQR: 18.0) and was reduced to 5.0% (IQR: 8.0) after four weeks, and to 2.0% (IQR: 7.25) in the surgical sample (p&lt; 0.0001). Other significant downgrading changes were observed with respect to tumor grade (p&lt; 0.0001) and progesterone receptor (PR) expression (p&lt; 0.0001). BCS was performed on 145 patients (86.3%). One case of pathological complete response was recorded. A larger Ki67 fold-change after four weeks was significantly related to a PEPI score of 0 (p&lt; 0.002). No differences were observed between luminal A- and B-like tumors with regard to fold-change and PEPI score. No treatment abandonment was produced during the study. Conclusions: In our cohort, NET has proven effective for tumor size and Ki67 downstaging. This results in a higher rate of conservative surgery, aids in therapeutic decision-making, provides prognostic information, and constitutes a safe and well-tolerated approach Biological changes after NET Patient and tumor characteristics Citation Format: Covadonga Marti, Laura Frias, Adolfo Loayza, Elisa Moreno, Marcos Meléndez, Jose Ignacio Sanchez-Mendez. Real World Data on Neoadjuvant Endocrine Treatment and Ki67 Assessment in ER+/HER2- Breast Cancer. Results from a Single-Institution Prospective Cohort Study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-09-03.

Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast conserving surgery (BCS) rates, and provides an opportunity for assessing in vivo NET effectiveness and studying any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the safety and effectiveness of NET, and to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness.Methods: From 2016 to 2020, a single-institution cohort of patients treated with NET and further surgery was evaluated. In patients with Ki67≥10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes was gathered.Results: A total of 115 estrogen receptor positive (ER+)/HER2 negative patients were included. The median treatment duration was 5.0 months (IQR: 2.0-6.0). Median maximum size in the surgical sample was 40% smaller than pretreatment size measured by ultrasound (p<.0001). Median pretreatment Ki67 expression was 20.0% (IQR: 12.0-30.0), and was reduced to 5.0% (IQR: 1.8-10.0) after four weeks, and to 2.0% (IQR: 1.0-8.0) in the surgical sample (p<.0001). BCS was performed on 98 patients (85.2%). No pathological complete responses were recorded. A larger Ki67 fold-change after four weeks was significantly related to a PEPI score of 0 (p<.002). No differences were observed between luminal A- and B-like tumors with regard to fold-change and PEPI score.Conclusions: In our cohort, NET has proven effective for tumor size and Ki67 downstaging. This results in a higher rate of conservative surgery, aids in therapeutic decision-making, provides prognostic information, and constitutes a safe and well-tolerated approach