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BACKGROUND: Fifteen to thirty percent of all patients with metastatic breast cancer (MBC) develop brain metastases (BCBMs). Recently, the antibody-drug conjugates (ADCs) sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have shown to be highly effective in the treatment of MBC. However, there are only limited data whether these macromolecules are also effective in patients with BCBMs. We therefore aimed to examine the efficacy of SG and T-DXd in patients with stable and active BCBMs in a multicenter real-world analysis. PATIENTS AND METHODS: Female patients with stable or active BCBMs who were treated with either SG or T-DXd at three breast centers in Germany before 30 June 2023 were included. As per local clinical praxis, chemotherapy efficacy was evaluated by whole-body computed tomography and cranial magnetic resonance imaging at baseline and at least every 3 months according to local standards. Growth dynamics of BCBMs were assessed by board-certified neuroradiologists. RESULTS: Of 26 patients, with a median of 2.5 prior therapy lines in the metastatic setting (range 2-15), 12 (43%) and 16 (57%) patients received SG and T-DXd, respectively. Out of the 12 patients who received SG, 2 (17%) were subsequently treated with T-DXd. Five out of 12 (42%) and 5 out of 16 (31%) patients treated with SG and T-DXd, respectively, had active BCBMs at treatment initiation. The intracranial disease control rate was 42% [95% confidence interval (CI) 13% to 71%] for patients treated with SG and 88% (95% CI 72% to 100%) for patients treated with T-DXd. After a median follow-up of 12.7 months, median intracranial progression-free survival was 2.7 months (95% CI 1.6-10.5 months) for SG and 11.2 months (95% CI 7.5-23.7 months) for T-DXd. CONCLUSIONS: SG and T-DXd showed promising clinical activity in both stable and active BCBMs. Further prospective clinical studies designed to investigate the efficacy of modern ADCs on active and stable BCBMs are urgently needed.
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BACKGROUND: Following the positive iDFS and OS results of the phase III clinical trials monarchE, NATALEE and OlympiA, new oral anticancer agents (the CDK4/6 inhibitors abemaciclib, ribociclib as well as the PARP inhibitor olaparib) have recently been introduced into the treatment of high-risk early breast cancer (eBC). However, only few male patients were included in these trials (0.4%, 0.6% and 0.3%, respectively). The objective of this real-world analysis was to determine the proportion of male patients with eBC fulfilling the clinical high-risk criteria of above-mentioned trials. PATIENTS AND METHODS: We conducted a data inquiry and analysis with the Cancer Registry of Baden-Württemberg of men with breast cancer diagnosed between January 1, 2015 and December 31, 2021. Men with eBC were identified and the number of patients at clinical high-risk according to the inclusion criteria of monarchE, NATALEE and OlympiA was assessed. RESULTS: Of 397 men with eBC, 354 (89.1%) had a HR + /Her2- and 4 (1.0%) a triple-negative subtype. 84 patients (21.2%) met the clinical high-risk criteria according to the monarchE, 189 (47.6%) those according to the NATALEE and 50 (12.6%) those according to the OlympiA trial. CONCLUSION: In a large real-world sample, more men with eBC are at clinical high risk according to the inclusion criteria of monarchE, NATALEE and OlympiA than would be expected in women. This is most likely due to more advanced stages at initial diagnosis in men. To evaluate whether CDK4/6 and PARP inhibitors improve prognosis also in men should be the topic of future real- world analyses.
RESUMO
OBJECTIVE: The objective of this study was to assess caesarean section (CS) rates before and after the implementation of the Project Appropriate Birth (PPA), based on the Robson ten group classification system. DESIGN: A before-and-after study. SETTING: Maternity hospital in South Brazil. POPULATION: All pregnant women attending from April 2016 to April 2017 (period 1, pre-implementation of PPA) and from June 2017 to June 2018 (period 2, post-implementation of PPA). METHODS: Maternal and obstetric characteristics were evaluated, including Robson's classification, based on the characteristics of pregnancy and childbirth. A chi-square test and crude and adjusted relative rates were used to analyse the study variables. The significance level was set at 5%. MAIN OUTCOME MEASURES: The CS rate for each group, their contribution to the overall CS rate and the differences in these contributions before and after PPA implementation. RESULTS: The CS rates decreased from 62.4 to 55.6%, which represented a 10.9% reduction after the implementation of the PPA. Pregnant women in Robson classification groups 1-4 had a 21.4% reduction in CS rates, ranging from 49.1 to 38.6%. The greatest contributors to the overall CS rates were group 5 and group 2, accounting for more than 60% of the CS deliveries. CONCLUSION: The study results suggest that Project Appropriate Birth had an impact on the reduction of CS rates, especially in Robson classification groups 1 through 4, which indicates that providing mothers with evidence-based interventions for labour and childbirth assistance contributed to reduce CS rates. TWEETABLE ABSTRACT: The Project Appropriate Birth is an innovative project that has demonstrated promising results, suggesting that interventions based on scientific evidence can lead to real changes in childbirth care, contributing to reduce CS rates. The aim of the PPA is to promote activities to improve childbirth care and encourage vaginal delivery. In this study, 6238 pregnant women admitted to the hospital for delivery were included and classified into one of the Robson 10-group classification. Findings revealed a 10.9% reduction in the overall CS rate and a 21.4% reduction for pregnant women in Robson classification groups 1 through 4, after the implementation of the PPA.
