Data documento
13/03/2025

Título
A Research Protocol for a Phase II Single-Arm Clinical Trial Assessing the Feasibility and Efficacy of Neoadjuvant Anastrozole in Patients With Luminal Breast Cancer and Low Proliferative Index: The ANNE Trial

Autor(es)
Carlos Eduardo Paiva - Alinne Tatiane Faria Silva - Izabella da Silva Oliveira - Vitor Souza Guimarães - Domício Carvalho Lacerda - Gustavo Ramos Teixeira - Anapaula Hidemi Uema Watanabe - Nilton Onari - Bianca Sakamoto Ribeiro Paiva - Idam de Oliveira-Junior - Marcia Maria Chiquitelli Marques - Yara Cristina de Paiva Maia.

Palavras chave
breast cancer - endocrine therapy - neoadjuvant - therapeutic response - anastrozole

Resumo
Introduction: Neoadjuvant endocrine therapy (NET) is recommended for the treatment of invasive breast cancer (BC), particularly luminal subtypes, in locally advanced stages. Previous randomized studies have demonstrated the benefits of aromatase inhibitors in this context. However, NET is typically reserved for elderly or frail patients who may not tolerate neoadjuvant chemotherapy. Identifying non-responsive patients early and extending treatment for responsive ones would be ideal, yet optimal strategies are awaited. Aims: This non-randomized phase 2 clinical trial aims to assess NET feasibility and efficacy in postmenopausal stage II and III luminal BC patients, identifying predictive therapeutic response biomarkers. Efficacy will be gauged by patients with Ki67 ≤ 10% after 4 weeks and Preoperative Endocrine Prognostic Index (PEPI) scores 0 post-surgery. Study feasibility will be determined by participation acceptance rate (recruitment rate ≥50%) and inclusion rate (>2 patients/month). Methods: Postmenopausal women with luminal, HER2-tumors in stages II and III undergo neoadjuvant anastrozole treatment, evaluating continuing NET or receiving chemotherapy through early Ki67 analysis after 2 to 4 weeks. The study assesses NET extension for up to 10 months, using serial follow-ups with standardized breast ultrasound and clinical criteria-based NET suspension. Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.

Citação
Paiva CE, Silva ATF, Oliveira IDS, Guimarães VS, Lacerda DC, Teixeira GR, Watanabe AHU, Onari N, Paiva BSR, Oliveira-Junior I, Marques MMC, Maia YCP. Cancer Control. 2024 Jan-Dec;31:10732748241272463. doi: 10.1177/10732748241272463. PMID: 39140157

Data documento
13/01/2024

Título
The Magee 3 Equation Predicts Favorable Pathologic Response to Neoadjuvant Endocrine Therapy in Breast Cancer Patients

Autor(es)
Carlos Eduardo Paiva - Maria Paola Montesso Zonta - Rafaela Carvalho Granero - Vitor Souza Guimarães - Layla Melo Pimenta - Gustavo Ramos Teixeira - Bianca Sakamoto Ribeiro Paiva.

Palavras chave
Magee equation; breast cancer; luminal; neoadjuvant endocrine therapy; pathologic response.

Resumo
Background: Breast cancer (BC) remains a significant health care challenge, and treatment approaches continue to evolve. Among these, neoadjuvant endocrine therapy (NET) has gained prominence, particularly for postmenopausal, hormone-receptor positive, HER2-negative (HR+/HER2-) BC patients. Despite this, a significant gap exists in identifying patients who stand to benefit from NET. The objective of this study was to assess whether Magee equations (MEs) could serve as predictors of response to NET. Methods: This retrospective study included adult patients with invasive BC who underwent NET followed by curative surgery. Assessment of sociodemographic, clinical, and tumor-related variables was conducted. The ME1, ME2, ME3, and ME mean were analyzed to explore their predictive role for NET response. Receiver operating characteristic (ROC) curves were employed, along with the determination of optimal cutoff points. Logistic regression models were utilized to identify the most significant predictors of pathological response. Results: Among the 75 female participants, the mean age was 69.4 years, with the majority being postmenopausal (n = 72, 96%) and having an ECOG-PS of 0/1 (n = 63, 84%). Most patients were classified as luminal A (n = 41, 54.7%). ME3 emerged as a promising predictor, boasting an AUC of 0.734, with sensitivity of 90.62% and specificity of 57.50% when the threshold was ≤ 19.97. In univariate analysis, clinical staging (p = 0.002), molecular subtype (p = 0.001), and ME3 (continuous = 0.001, original 3-tier: p = 0.013, new 2-tier: <0.001) categories exhibited significant associations with pathological response. In the multivariate model, clinical staging and new 2-tier ME3 (<20 vs. ≥20) were included as significant variables. Conclusions: Patients with ME3 < 20 have a higher likelihood of presenting a pathological response, offering a cost-effective alternative tool to Oncotype DX. Larger future studies with a prospective design are awaited to confirm our findings.

Citação
The Magee 3 Equation Predicts Favorable Pathologic Response to Neoadjuvant Endocrine Therapy in Breast Cancer Patients.Paiva CE, Zonta MPM, Granero RC, Guimarães VS, Pimenta LM, Teixeira GR, Paiva BSR.Cancers (Basel). 2024 Jan 13;16(2):339. doi: 10.3390/cancers16020339. PMID: 38254828