Background: Treatment with anti-HER2 therapy significantly improved survival outcomes in patients with HER2-positive Breast Cancer (BC). In Brazil, Trastuzumab was the first biosimilar approved in the treatment of patients with breast (any disease setting) and advanced gastric cancer with overexpression of HER2. Increase access to this important treatment may be enhanced with biosimilar approval. The aim of this Real-World study is to assess the efficacy and safety of adjuvant biosimilar trastuzumab in Brazilian patients with early HER2+ BC. Methods: This is a national, multicenter, observational prospective, real-world study in a variety of Brazilian institutions. A hundred and seventy adult patients, with diagnosis of early stage HER2-positive breast cancer, who received at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy will be included. Patients will be followed for 5 years after the use of biosimilar trastuzumab (Zedora), unless recurrence or death. Safety outcomes will be recorded. Efficacy outcomes include invasive relapse-free survival (IRFS) rate at 18, 24, 30 and 36 months treatment initiation. Given the inexistence of a specific hypothesis to be tested, sample size was based on the accuracy of the two-sided 95% confidence interval (95% CI) for the invasive disease relapse-free survival rate. Results: In development countries such as as Brazil, oncology treatments with biological drugs have high costs and represent an import ibarrier to patients access to anti HER2 therapy. The use of biosimilars may result in significant health care savings. Conclusions: Considering the HERITAGE study, in which biosimilarity was clearly demonstrated between the reference monoclonal antibody and the biosimilar, we do expect to find the same safety and efficacy profile. Citation Format: Leandro Alves, Débora Gagliato, Mayara de Paula, Ana Carolina Cardoso, Alexandre Alcantara, Maristela Precivale, Vivienne Castilho. A prospective real-world national study to evaluate the efficacy and safety of adjuvant biosimilar trastuzumab in the treatment of HER2-positive breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT2-01-05.

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Introduction: In recent years, it has been observed that the prevalence of breastfeeding (BF) is below the standards established by the World Health Organization (WHO) and childhood obesity rates have shown exponential growth. The correlation between both is the subject of studies, since it is possible to analyze the benefits of BF in the prevention of childhood obesity. The aim of the present study was to identify and describe evidence about the correlation between breastfeeding and protection/prevention against childhood obesity. Method: This is a qualitative research with the application of integrative literature review standards, in order to obtain evidence from various types of studies on the researched topic. A search was carried out for scientific articles available in electronic media, published in the last five years, from April to mid-May 2022. Results: 140 articles were found, of which 10 were selected after analysis, according to research criteria. Conclusion: There is a direct relationship between the practice of breastfeeding and the prevention of overweight, especially when the offer is exclusive up to 6 months. The duration of breastfeeding has an influence on overweight and obesity protection.

Background: trastuzumab (TZB) is approved for the treatment of HER2-positive (HER2+) breast cancer in different indications and schemes. The association of pertuzumab (PTZ) in some regimens has shown to improve the clinical benefit. Recently, biosimilars (BS) of trastuzumab were approved after extensive exercises of comparison with the originator, proving that these new biologicals are highly similar in structure and biological activity, and inherent microheterogeneity is not clinically relevant, since efficacy, safety and immunogenicity were found to be equivalent in pivotal phase 3 trials. In this study, we aimed to compare binding and biological activities of biosimilar trastuzumab (BS-TZB) or trastuzumab originator in association with PTZ in cell culture-based assays. Methods: two cancer cell lines were used to perform all the tests: BT474 (HER2+/ progesterone (PR) and estrogen receptor (ER)- positive) and HCC1954 (HER2+/PR and ER-negative); fluorescent labeling of trastuzumab originator (Herceptin®- Produtos Roche Químicos e Farmacêuticos S.A.) with Alexa 488, biosimilar of trastuzumab (trastuzumab-dkst, Biocon Limited/ Zedora- Libbs Farmacêutica Ltda.) with Alexa 488 and pertuzumab (Perjeta®- Produtos Roche Químicos e Farmacêuticos S.A.) with Alexa 647; FACS-based antigen binding evaluations and live cell imaging were performed (TZB or BS-TZB, and PTZ at concentrations of: 0; 10; 100; 1,000 ng/mL in every combinations. Predefined acceptance criteria for ligand-binding assay (LBA) was ±20% (25% at lower limit of quantification - LLOQ). Proliferation and CDC (complement-dependent cytotoxicity) assays: TZB or BS-TZB were tested at concentrations of: 0.01; 0.03; 0.1; 0.3; 1; 3; 10; 30; 100 μg/mL combined with PTZ at concentrations 1; 10; 100 μg/mL; the number of viable cells were estimated by quantitation of the ATP present using the CellTiter-Glo® kit. Equivalence was stablished with 95% confidence if 90% confidence interval (CI) of difference between means (DBM) lies within the zone of indifference (±20%). Results: tests were done using different concentrations and combinations of antibodies. For LBA, results are shown with concentrations in which the effect was neither minimal nor maximal (for both cell lines: 100 ng/mL for PTZ; 1,000 ng/mL for TZB or BS-TZB) (Table 1). For proliferation and CDC analysis, results at concentrations 100 μg/mL for PTZ, and TZB or BS-TZB (for both cell lines) are shown as a ratio to control. Table 1: Ligand-binding, proliferation and CDC assays. SD: standard deviation.Cell lineAnti-bodiesLBA (% cells) mean ± SDDBM 90% CIProliferation (ratio) mean ±SDDBM 90% CICDC (% cells) mean ± SDDBM 90% CIBT474BS-TZB + PTZ69.6 ±0.3-4.5 to -3.465.3 ±2.5-7.2 to -0.358.2 ±0.1-5.8 to -3.2TZB + PTZ73.5 ±0.369.6 ±1.262.8 ±1.1HCC1954BS-TZB + PTZ94.2 ±0.35.8 to 6.480.5 ±1.9-14.3 to -0.349.8 ±0.1-4.3 to -1.9TZB + PTZ88.1 ±0.187.8 ±5.452.9 ±1.0 Conclusions: trastuzumab and pertuzumab bind to HER2 receptor at different subdomains acting synergistically and, ultimately, improving the clinical benefit. In this study we comparatively evaluated the ligand and biological activities of the biosimilar BS-TZB and the TZB originator in the presence of PTZ. In addition to the previous findings of highly similar structure and biological activities of biosimilar to its originator, this study showed that not only PTZ binding to HER2 domain II but also biological activity showed the same pattern in the presence of BS-TZB as well as in the presence of TZB. Herein, in evaluated mechanisms, we have showed that the combination of BS-TZB and PTZ are highly similar to the combination of TZB and PTZ. Citation Format: Franklin F Pimentel, Juliano S Toledo, João Gonçalves, Leandro L Alves, Mayara I de Paula, Jurandyr M de Andrade, Daniel G Tiezzi, Roger Chammas. Comparative evaluation of a trastuzumab biosimilar or originator trastuzumab in association with pertuzumab: Binding and biological activities in cell culture-based assays [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-05-08.

IntroductionDementia has a significant psychological and emotional impact on families, especially for caregivers of people living with dementia. In this perspective, the World Health Organization has developed iSupport for Dementia, an online training and skills program to prevent and/or reduce mental health problems associated with the provision of care and improve the quality of life of caregivers. It is being translated and adapted in different countries and as of August 2022, 31 adaptations using 27 different languages were in progress. However, the availability of the program should only be carried out after evaluating its effects on caregivers’ mental health outcomes (such as burden, depressive and anxious symptoms, quality of life, among others).ObjectivesTo analyze randomized clinical trial protocols to assess the effects of the iSupport program in different countries.MethodsThis is a data survey carried out in October 2022 on clinical trial registry platforms Clinical Trials, The Brazilian Registry of Clinical Trials, Cochrane Central Register of Controlled Trials, Netherlands Trial Register and Australian New Zealand Clinical Trials Registry by two independent researchers. Descriptive analyzis were performed for sample size, primary outcomes, secondary outcomes and intervention design.ResultsSeven clinical trial registries were identified, conducted in Australia/China, Brazil, Great Britain, the Netherlands, India, Japan and Portugal, published in English, from 2018 to 2022. The sample size ranged from 184 to 390 participants. Regarding the primary outcomes linked to the effect of using iSupport, five countries will analyze burden, anxiety and depression. Only in Australia/China and the Netherlands, the primary outcome will be quality of life and stress, respectively. Secondary outcomes vary between studies, with measures of quality of life (n=6), self-efficacy (n=4), program usability (n=4), cognition and problematic behaviors (n=3), attitudes (n=3), quality of support (n=3), positive aspects of care (n=2), knowledge, competence, resilience and informal costs of care (n=1). Most studies will carry out assessments at baseline, 3 and 6 months after the intervention, with the exception of Japan that will perform at baseline and at 1 and 3 months after the intervention and 6 months.ConclusionsAnalysis of the effectiveness of iSupport is one of the World Health Organization guidelines for countries that are culturally adapting this program. Brazil is the only country in Latin America with a clinical trial registration so far. Burden, anxiety and depression are outcomes considered by most countries. The results could provide evidence to strengthen and expand the possibilities for collaboration between researchers, as internet-based interventions have shown promising results on the mental health and well-being.Disclosure of InterestNone Declared