ABSTRACT
OBJECTIVES: The Lewis-Y antigen is expressed in 44%-90% of breast cancers (BCs). The expression of the antigen in carcinoma tissue differs from that in normal tissues. This study aimed to evaluate the clinical benefit of the humanized anti-Lewis Y monoclonal antibody, hu3S193, in advanced hormone receptor-positive and Lewis Y-positive BC after administration of endocrine therapy (ET). METHODS: A single-arm phase II study was conducted in seven centers. Patients with advanced hormone receptor-positive BC who failed first-line ET were included. The inclusion criterion was the observation of tumoral expression of the Lewis Y antigen during immunohistochemistry. The treatment comprised hu3S193 antibody administration at weekly intravenous doses of 20 mg/m2 for 8-week cycles. The primary endpoint was the clinical benefit rate. ClinicalTrials.gov NCT01370239. RESULTS: The study stopped accrual following an unplanned interim analysis as the hu3S193 antibody lacked sufficient activity to justify continuation of the study. Twenty-two patients were enrolled, of whom 21 were included in the efficacy analysis. The clinical benefit rate was 19%, with four patients presenting with stable disease after 24 weeks. One patient with prolonged stable disease received medication for over 2 years. No partial or complete responses were observed. The median time to progression and overall survival was 5.4 and 37.5 months, respectively. CONCLUSIONS: The humanized anti-Lewis Y monoclonal antibody, hu3S193, exhibited insufficient activity in this cohort. However, the possibility of activity in a more strictly selected subgroup of patients with higher levels of Lewis Y tumoral expression cannot be overlooked.
Subject(s)
Humans , Female , Breast Neoplasms/drug therapy , Carcinoma , Immunohistochemistry , Antineoplastic Combined Chemotherapy Protocols , Hormones , Antibodies, Monoclonal/therapeutic useABSTRACT
Resumo O desafio imposto ao sistema de saúde pela pandemia da COVID-19 faz com que haja uma necessidade de readequações de rotinas e serviços de saúde, com os objetivos de controlar a disseminação do vírus e preservar a saúde. Torna-se ainda mais importante o manejo seguro e correto dos pacientes dos grupos de risco, como os pacientes idosos, os portadores de doenças cardiovasculares e os pacientes com câncer. Dessa forma, a cardio-oncologia ganha novo dimensionamento, no intuito de se adequar às necessidades dos pacientes diante de uma pandemia, reestruturando o sistema de atendimento de forma a oferecer qualidade e segurança na assistência à saúde.
Abstract The challenges that the COVID-19 pandemic cretead to the healthcare system have made it necessary to adapt routines and services, with the objectives of controlling the spread of the virus and preserving health. Safe and correct management of patients in risks groups, such as elderly patients, patients with cardiovascular diseases, and patients with cancer, has become even more important. Thus, cardio-oncology has gained a new dimension, with the aim of adapting to patients' needs during the pandemic by restructuring the system of care in a manner that offers quality and safety in healthcare.
Subject(s)
Cardiovascular Diseases/complications , Coronavirus Infections , Severe Acute Respiratory Syndrome , Neoplasms/complications , Coronavirus , Pandemics , BetacoronavirusABSTRACT
Em 2010, um milhão e meio de mulheres receberão o diagnóstico de câncer de mama no mundo, sendo 49.000 no Brasil. O câncer de mama e uma área em constante evolução, exigindo, tanto da parte de mastologistas quanto dos oncologistas, rápida adaptação aos novos conceitos. Sabe-se que o câncer de mama não e uma doença única e, portanto, seu tratamento deve ser individualizado. A quimioterapia é uma parte importante do tratamento desta doença e tem evoluído recentemente, juntamente com a cirurgia, hormonioterapia, radioterapia e outros tratamentos de suporte, fazendo com que a mortalidade por esta doença continue a diminuir. Baseado em dados dos estudos de perfil molecular, e possível que mais de 50% das pacientes recebam quimioterapia adjuvante desnecessariamente. Revisa-se aqui o papel dos novos testes de perfil molecular disponíveis e o estado atual do uso de quimioterapia no câncer de mama. Nesta revisão, e dado especial enfoque ao tratamento adjuvante e neoadjuvante, sendo descritas algumas particularidades como o tratamento das pacientes idosas, da doença HER-2 positiva e da doença metastática.
In 2010, one and a half million women will be diagnosed with breast cancer worldwide, and 49, 000 in Brazil. Breast cancer is a constantly evolving area requiring from Mastologists and Oncologists a fast adaptation to new concepts. Furthermore, breast cancer does not consist of a single entity, therefore, it requires individualized treatment approaches. Chemotherapy is an important treatment modality, and it has been a rapidly evolving area that has been contributing to the decreasing breast cancer mortality observed in recent years, along with surgery, hormone therapy, radiotherapy, and other supportive treatments. Based on data from molecular profiling studies, more than 50% of the patients may be receiving unnecessary adjuvant chemotherapy. We aim to review the role of new molecular profiling tests and the current state of art in chemotherapy treatment for breast cancer. We also address the important issue of chemotherapy treatment in elderly patients, and the management of HER -2 positive and metastatic disease.