Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers.

Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world

The globalisation of breast cancer

Boyle, Peter Howell, Antony eng England 2011/01/05 06:00 Breast Cancer Res. 2010 Dec 20;12 Suppl 4:S7. doi: 10.1186/bcr2736.International audienceno abstrac

XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Abstract Background Recombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen™ after myelotoxic chemotherapy in breast cancer (BC) patients. Methods A total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were randomised to treatment with daily injections (subcutaneous 5 μg/kg/day) for at least 5 days and a maximum of 14 days in each cycle of XM02 (n = 140), Neupogen™ (n = 136) or placebo (n = 72). The primary endpoint was the duration of severe neutropenia (DSN) in cycle 1. Results The mean DSN in cycle 1 was 1.1, 1.1, and 3.9 days in the XM02, Neupogen™, and placebo group, respectively. Superiority of XM02 over placebo and equivalence of XM02 with Neupogen™ could be demonstrated. Toxicities were similar between XM02 and Neupogen™. Conclusion XM02 was superior to placebo and equivalent to Neupogen™ in reducing DSN after myelotoxic chemotherapy. Trial Registration Current Controlled Trials ISRCTN02270769</p

Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial

Purpose Equivalent efficacy was demonstrated for the biosimilar CT-P6 and trastuzumab following neoadjuvant therapy for patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Following adjuvant treatment, efficacy and safety were comparable between treatments. We report updated safety and efficacy data after up to 3 years’ follow-up. Methods Following neoadjuvant chemotherapy with CT-P6/trastuzumab, patients underwent surgery and continued receiving adjuvant CT-P6/trastuzumab. The primary endpoint (previously reported) was pathological complete response. Time-to-event analyses (disease-free survival [DFS], progression-free survival [PFS], and overall survival [OS]), study drug-related and cardiac adverse events, and immunogenicity were assessed during post-treatment follow-up. Results Most patients entered the follow-up period (CT-P6: 259 [95.6%]; trastuzumab: 269 [96.8%]). After a median follow-up of 38.7 (CT-P6) and 39.6 (trastuzumab) months, medians were not reached for time-to-event parameters; estimated hazard ratios (HRs) and 3-year survival rates were similar between groups. Estimated HRs (95% confidence intervals) for CT-P6 versus trastuzumab were 1.23 (0.78–1.93) for DFS, 1.31 (0.86–2.01) for PFS, and 1.10 (0.57–2.13) for OS (intention-to-treat population). Safety findings were comparable between groups for the overall study and follow-up period, including study drug-related cardiac disorders (CT-P6: 22 [8.1%] patients; trastuzumab: 24 [8.6%] patients [overall]) and decreases in left ventricular ejection fraction. Immunogenicity was similar between groups. Conclusion The similarity of the time-to-event analyses between CT-P6 and trastuzumab supports the equivalence in terms of efficacy established for the primary endpoint. CT-P6 was well tolerated, with comparable safety and immunogenicity to trastuzumab. ClinicalTrials.gov: NCT02162667 (registered June 13, 2014

5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

This ESO-ESMO ABC 5 Clinical Practice Guideline provides key recommendations for managing advanced breast cancer patients. It provides updates on managing patients with all breast cancer subtypes, LABC, follow-up, palliative and supportive care. Updated diagnostic and treatment algorithms are also provided. All recommendations were compiled by a multidisciplinary group of international experts. Recommendations are based on available clinical evidence and the collective expert opinion of the authors

Os Momentos de transição nas rotinas de creche e de jardim de infância

Relatório do Projeto de Investigação Mestrado em Educação Pré-Escolar Versão Definitiva JaneiroO presente Relatório do Projeto de Investigação representa um estudo transversal alicerçado nas vivências ocorridas nos contextos de estágio, por outras palavras, no estágio em Creche e o no estágio em Jardim de Infância, no âmbito do Mestrado em Educação Pré-Escolar. No estudo participaram as duas Educadoras Cooperantes e os respetivos grupos de crianças. A temática em estudo consiste nos Momentos de Transição, isto é, os momentos em que as crianças transitam de uma atividade para a seguinte, e a metodologia que se considera mais apropriada ao estudo empírico posiciona-se na abordagem da investigação-ação. O método de recolha de informação baseia-se na observação participante, nas notas de campo e na análise documental, sendo complementada com inquéritos por questionário apresentados às Educadoras Cooperantes. Em jeito de complementaridade, articulam-se as experiências vivenciadas nos contextos. Este Projeto de Investigação tem como intencionalidade, refletir acerca da relação existente entre as conceções das Educadoras Cooperantes e as suas práticas pedagógicas, bem como, implementar melhorias, nas salas dos contextos de estágio, no que diz respeito à gestão dos momentos de transição. A partir desta investigação, é possível compreender que os momentos de transição são, de facto, valorizados nas conceções das Educadoras Cooperantes como momentos que requerem atenção e planeamento, porém efetivamente nem sempre a intervenção é congruente com o que defendem.This Report of the Investigation Project represents a cross-sectional study based on experiences that occured in the two internships - on nursery and on kindergarten. The two Cooperating Educators and their respective groups of children had participated in the study. The theme under study consist in the Moments of Transition, that is, the moments when the children move from one activity to the next one, and the methodology which is considered more appropriated to the empirical study is positioned in the action-research approach. The collecting information method is based on participant observation, field notes and document analysis, being complemented with questionnaire surveys presented to the Cooperating Educators. In a way of complementarity, the experiences lived in the contexts are articulated. This Investigation Project intends to reflect about the relationship between the Cooperating Educators concepts and their practices, it also intends to implement improvements in the rooms of the internship contexts, when it comes to the management of transition moments. From this investigation, it is possible to understand that transition moments are, in fact, valued in the Cooperative Educators conceptions as moments that require attention and planning, however, the intervention is not always consistent with what they defend

Enhancing global access to cancer medicines

Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high-quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff. © 2020 American Cancer Societ

Molecular targeted therapies for breast cancer treatment

Targeting the oestrogen receptor, HER2 (human epidermal growth factor receptor 2) and vascular endothelial growth factor has markedly improved breast cancer therapy. New targeted therapeutic approaches to induction of apoptosis or inhibition of anti-apoptosis, cell cycle progression, signal transduction and angiogenesis are described. The molecular pathways and their inhibitory or repair mechanisms are discussed in the preclinical and clinical settings

5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

The ESO-ESMO 5th international consensus recommendations for advanced breast cancer (ABC 5) provide the latest updates on the management of patients with all breast cancer subtypes, locally advanced breast cancer, follow-up, palliative and supportive care and integrative medicine. Updated diagnostic and treatment algorithms are also provided, as well as several new therapies/indications in advanced breast cancer now approved by the European Medicines Agency