Neoadjuvant carboplatin in triple-negative breast cancer: results from NACATRINE, a randomized phase II clinical trial.

BACKGROUND: Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of stages II and III triple-negative breast cancer (TNBC). This study aims to evaluate if the addition of carboplatin to NACT is associated with an increase in the pathological complete response (pCR) rates in TNBC. METHODS: We conducted an open-label phase II randomized clinical trial in a single center in Brazil. Patients with stage II and III TNBC were randomized to receive standard NACT with or without carboplatin. All the patients received doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) both intravenously (i.v.) q21 days for four cycles. Patients were then randomized for additional treatment with weekly (wk) paclitaxel (80 mg/m2 i.v., for 12 cycles) plus wk carboplatin AUC 1.5 (experimental arm) or without wk carboplatin (control arm). Randomization was stratified according to gBRCA status, age, and AJCC 8th edition clinical stage (II vs. III). The primary endpoint was the pathologic complete response (pCR) rate. Secondary endpoints included recurrence-free survival and overall survival. RESULTS: Between 2017 and 2021, 146 patients were randomized, 73 on each arm. The median age was 45 years. Most patients (66.4%) had locally advanced stage III disease, 67.1% had T3/T4 tumors, and 56.2% had clinically positive axillary lymph nodes. Germline BRCA status was available for all patients, and 19.9% had pathogenic BRCA1/2 variants. The pCR rate (ypT0ypN0) was numerically increased by 13.7%, being 43.8% (31 of 73 patients) in the experimental and 30.1% (22 of 73 patients) in the control arm, not meeting the prespecified goal of increasing the pCR in 15% (p-value = 0.08). Survival outcomes are immature. CONCLUSION: The addition of carboplatin to standard NACT in stages II and III TNBC was associated with a non-statistically significant numerical increase in the pCR rate. Follow-up for survival outcomes and translational research initiatives are ongoing.

The Functionality Assessment Flowchart (FAF): a new simple and reliable method to measure performance status with a high percentage of agreement between observers.

BACKGROUND: Performance status (PS) assessment is an integral part of the decision-making process in cancer care. Karnofsky Performance Status (KPS) and Eastern Cooperative Oncology Group (ECOG) PS are the most widely used tools. In some studies, the absolute agreement rate of these tools between observers has been moderate to low. The present study aimed to evaluate the inter-observer reliability and construct validity of the new Functionality Assessment Flowchart (FAF) and compare it with ECOG PS and KPS in a sample of cancer patients. METHODS: The patients were recruited by convenience from the waiting rooms of the Breast and Gynecology Ambulatory in a cross-sectional study. Two trained medical students (observer A) and five medical oncologists (observers B) independently rated women according to the ECOG PS, KPS and FAF. After the determining the PS scores, observer A administered the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire to the participants. The agreements between observers A and B were investigated using the absolute agreement rate (%), weighted and unweighted kappa and Spearman's correlation test. For construct validity, the PS scores were correlated with functional and fatigue scores by performing correlation analysis. RESULTS: Eighty women with a median age of 57 years were included in the study (86% accrual rate). Among these women, 39 (48.8%) had advanced cancer. The overall absolute agreement rate between observers was 49.4% for KPS, 67% for ECOG PS, and 78.2% for FAF. When using unweighted kappa values, the inter-observer reliability was "fair", "moderate" and "substantial" for KPS, ECOG PS and FAF, respectively. However, when using weighted kappa statistics, "substantial" agreement was observed for KPS and ECOG PS and "nearly perfect" agreement was observed for FAF. All of the PS scales correlated very well with the functional and fatigue scores. CONCLUSIONS: We present a new instrument with moderate to high inter-observer agreement and adequate construct validity to measure PS in cancer patients.

Pseudotumoral presentation of chronic pulmonary schistosomiasis without pulmonary hypertension.

Schistosomiasis is a disease that, in Brazil, is caused by Schistosoma mansoni and is transmitted by snails of the genus Biomphalaria. This species occurs in Africa, the Antilles and South America. The parasite, developing to the adult stage in the vascular system of the host, migrates to the mesenteric veins. Each female lays approximately 400 eggs per day, and these travel from the submucosa to the intestinal lumen. There have been reported cases in which S. mansoni eggs were identified in the lungs of patients with no evidence of liver fibrosis. We report a case with this atypical presentation of the disease. The patient presented nonpleuritic chest pain, significant weight loss and dry cough. A CT scan revealed an irregular tumor in the left lower lobe. However, a lung biopsy revealed non-viable S. mansoni eggs. The patient presented no clinical signs of pulmonary or portal hypertension; nor was either identified through diagnostic tests.

Forma pseudoneoplásica de esquistossomose pulmonar crônica sem hipertensão pulmonar / Pseudotumoral presentation of chronic pulmonary schistosomiasis without pulmonary hypertension

A esquistossomose é uma doença que, no Brasil, é causada pelo Schistosoma mansoni e transmitida através da água por moluscos do gênero Biomphalaria. Essa espécie ocorre na África, nas Antilhas e na América do Sul. O parasita, ao atingir a fase adulta de seu ciclo biológico no sistema vascular do homem, alcança as veias mesentéricas. Cada fêmea põe cerca de 400 ovos por dia, e estes, a partir da submucosa, chegam à luz intestinal. Há relatos de casos a respeito de ovos de S. mansoni nos pulmões de pacientes sem evidência de fibrose hepática. Relatamos um caso dessa forma atípica de apresentação da doença. O paciente apresentava dor torácica não-ventilatóriodependente, perda ponderal significativa e tosse seca. A TC de tórax mostrou uma tumoração irregular no lobo inferior esquerdo, mas somente a biópsia pulmonar evidenciou ovos de S. mansoni degenerados. O paciente não apresentava sinais clínicos de hipertensão pulmonar ou portal, as quais tampouco foram diagnosticadas através de exames.

Schistosomiasis is a disease that, in Brazil, is caused by Schistosoma mansoni and is transmitted by snails of the genus Biomphalaria. This species occurs in Africa, the Antilles and South America. The parasite, developing to the adult stage in the vascular system of the host, migrates to the mesenteric veins. Each female lays approximately 400 eggs per day, and these travel from the submucosa to the intestinal lumen. There have been reported cases in which S. mansoni eggs were identified in the lungs of patients with no evidence of liver fibrosis. We report a case with this atypical presentation of the disease. The patient presented nonpleuritic chest pain, significant weight loss and dry cough. A CT scan revealed an irregular tumor in the left lower lobe. However, a lung biopsy revealed non-viable S. mansoni eggs. The patient presented no clinical signs of pulmonary or portal hypertension; nor was either identified through diagnostic tests.

Primary nodular hepatic tuberculosis mimicking hepatic neoplasia in an immunocompetent host

We present and describe a case of nodular primary hepatic tuberculosis mimicking hepatic neoplasia in an immunocompetent host. This particularly rare presentation, associated with unspecific imaging, laboratory andclinical findings and relatively unspecific microbiological results make diagnosis extremely difficult, usually requiring surgical intervention.

Primary nodular hepatic tuberculosis mimicking hepatic neoplasia in an immunocompetent host.

We present and describe a case of nodular primary hepatic tuberculosis mimicking hepatic neoplasia in an immunocompetent host. This particularly rare presentation, associated with unspecific imaging, laboratory and clinical findings and relatively unspecific microbiological results make diagnosis extremely difficult, usually requiring surgical intervention.