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IntroductionBreast cancer (BC) is one of the leading causes of cancer and is the first cause of death from malignant tumors among women worldwide. New cancer therapies receive regulatory approval yearly and to avoid health disparities in society, the health systems are challenged to adapt their infrastructure, methodologies, and reimbursement policies to allow broad access to these treatments. In addition, listening to patients’ voices about their therapy preferences is essential. We aim to investigate the administration route preferences [subcutaneous (SC) or intravenous (IV)] among patients diagnosed with HER2 positive BC and healthcare professionals (HCPs) and to investigate healthcare resources utilization (quality and quantity) for each route of administration (SC or IV) for treating those patients.MethodsWe conducted a systematic literature review focused on clinical trials and observational and economic studies, using PubMed (MEDLINE), Cochrane Library, Virtual Health Library (VHL), Scientific Electronic Library Online (SciELO), and Latin American and Caribbean Health Sciences Literature (LILACS) databases based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.ResultsThe literature review included 25 studies in the analysis. Studies have reported that patients and HCPs prefer the SC route of administration to IV because it saves time in terms of chair time, administration, and preparation and is less painful. In addition, SC administration might be a more cost-saving option when analyzing direct and indirect costs.DiscussionAs BC stands as a significant global health concern and the leading cause of cancer-related deaths in women worldwide, understanding and incorporating patient and HCPs preferences in the choice of administration route become paramount. The observed preference for SC administration not only aligns with the imperative of adapting health systems to facilitate broad access to new cancer therapies but also underscores the importance of considering patient experiences and economic implications in shaping treatment strategies. These insights are crucial for healthcare policymakers, clinicians, and stakeholders in optimizing healthcare resources and enhancing the overall quality of BC care.

Introdução: O câncer de mama (CM) é um dos tipos de câncer mais prevalentes e é a primeira causa de morte por tumores malignos entre as mulheres em todo o mundo. Novas terapias recebem aprovação regulatória anualmente, e os sistemas de saúde são desafiados a adaptar sua infraestrutura, metodologias e políticas de reembolso para permitir o amplo acesso. A combinação de dose fixa subcutânea (SC), pronta para uso, de Pertuzumabe e Trastuzumabe (pertuzumabe, trastuzumabe e hialuronidase- zzxf; PH FDC SC) foi aprovada em dezembro de 2021 pela Anvisa e em fevereiro de 2022 pela CMED, para tratar pacientes adultos com câncer de mama inicial e metastático HER2-positivo. O estudo pivotal (PHranceSCa) Fase 2 de PHESGO FDC SC demonstrou que a maioria dos pacientes preferem PHESGO FDC SC em comparação a combinação de Pertuzumabe intravenoso (IV) e Trastuzumabe (IV) (SC: 85,0%; IV: 13,8%; sem preferência: 1,3%). Objetivos: Investigar as preferências pelas vias de administração medicamentosa por infusão (SC ou IV) entre pacientes e profissionais de saúde (PS) (médicos, enfermeiros, psicólogos e outros) para tratamento do câncer de mama HER2-positivo. Material e Método: Foi realizada uma revisão sistemática da literatura (RSL) focada em ensaios clínicos e estudos observacionais, utilizando PubMed (MEDLINE), Biblioteca Cochrane, Biblioteca Virtual em Saúde (BVS), Scientific Electronic Library Online (SciELO) e Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) com base na declaração Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).Resultados: A RSL incluiu 5 ensaios clínicos randomizados na análise dos achados: PrefHer (NCT01401166), GAIN-2 (NCT01690702), PHranceSCa Trial (NCT03674112), MetaspHer (NCT01810393) e ChangHER (NCT01875367). Como tendência observada, os estudos relataram que pacientes e OS preferem a via de administração SC à via IV. Os principais motivos apontados pelos estudos para justificar a preferência pela a via de administração SC incluem economia de tempo, menos dor, desconforto e efeitos colaterais; promovendo benefício no volume de trabalho da equipe, reduzindo desperdício, possibilitando menores tempos de infusão e observação nas doses de ataque e de manutenção, gerando redução significativa do tempo de cadeira. Os PS concordaram que a via de administração SC economiza tempo de preparação e administração exigindo menos recursos para o preparo. Discussão e Conclusões: É possível demonstrar que há uma tendência a favor da administração SC em todas as publicações. A via de administração SC demonstrou oferecer benefícios tanto para os pacientes quanto para os profissionais de saúde. Esses dados devem fornecer evidências de suporte para uma mudança na prática em relação à administração da terapia anti-HER2, independentemente do cenário de doença - inicial ou metastático.

Abstract Background Adoption of molecular pathology in Brazil is currently very limited. Of note, there are no programs for training new molecular pathologists in the country; thus, documents compiling nationally applicable information on molecular pathology are few. Methods A selected panel of Brazilian experts in fields related to molecular pathology were provided with a series of relevant questions to address prior to the multi-day conference. Within this conference, each narrative was discussed and edited by the entire group, through numerous drafts and rounds of discussion until a consensus was achieved. Results The panel proposes specific and realistic recommendations for implementing molecular pathology in cancer care in Brazil. In creating these recommendations, the authors strived to address all barriers to the widespread use and impediments to access mentioned previously within this manuscript. Conclusion This manuscript provides a review of molecular pathology principles as well as the current state of molecular pathology in Brazil. Additionally, the panel proposes practical and actionable recommendations for the implementation of molecular pathology throughout the country in order to increase awareness of the importance molecular pathology in Brazil.

Background: The global burden of breast cancer (BC) is high, especially in advanced stages. CDK 4/6 inhibitors represent a paradigm shift in the treatment of advanced BC HR+/HER2−, given the clinically and statistically significant gain in overall survival associated with this new class of medications. Nevertheless, as an innovation, the incorporation of these drugs impacts healthcare budgets, requiring cost-effectiveness analyses for decision-making. The aim of this study was to evaluate the cost-effectiveness of ribociclib plus letrozole compared with palbociclib plus letrozole or letrozole as monotherapy for first-line treatment of postmenopausal women with HR+/HER2− locally advanced or metastatic BC (aBC) from a Brazilian private healthcare system perspective. Methods: A model including progression-free survival (PFS), progressed disease, and death health states was used to simulate lifetime costs and outcomes. PFS and overall survival were derived from the MONALEESA-2 trial (lifetime horizon). Healthcare costs included drug acquisition and monitoring, subsequent therapies, adverse events, and end-of-life costs. Effectiveness was measured in quality-adjusted life-years (QALYs). Deterministic and probabilistic sensitivity analyses were performed. Results: The total cost of treatment with ribociclib plus letrozole was USD 72,091.82 versus USD 92,749.64 for palbociclib plus letrozole. Total QALYs were 3.30 and 3.16, respectively. Base-case analysis showed ribociclib as dominant over palbociclib in first-line treatment of women with HR+/HER2− aBC, associated with cost savings and QALY gains. The total cost of treatment with ribociclib plus letrozole was USD 83,058.73 versus USD 29,215.10 for letrozole. Total QALYs were 3.84 and 2.61, respectively. Compared with letrozole, ribociclib plus letrozole was associated with an incremental cost of USD 53,843.64 and an incremental QALY gain of 1.23, with incremental cost-effectiveness ratio of USD 43,826.91 per QALY gained. Conclusions: As demonstrated by the cost-effectiveness dominance over palbociclib, ribociclib results in savings when used as first-line treatment in postmenopausal women with HR+/HER2− aBC, warranting incorporation in the private healthcare system.