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Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.

ABSTRACT: The development of anti-HER2 agents has been one of the most meaningful advancements in the management of metastatic breast cancer, significantly improving survival outcomes. Despite the efficacy of anti-HER2 monoclonal antibodies, concurrent chemotherapy is still needed to maximize response. Antibody-drug conjugates (ADCs) are a class of therapeutics that combines an antigen-specific antibody backbone with a potent cytotoxic payload, resulting in an improved therapeutic index. Two anti-HER2 ADCs have been approved by the FDA with different indications in HER2-positive breast cancer. Ado-trastuzumab emtansine (T-DM1) was the first-in-class HER2-targeting ADC, initially approved in 2013 for metastatic patients who previously received trastuzumab and a taxane, and the label was expanded in 2019 to include adjuvant treatment of high-risk patients with residual disease after neoadjuvant taxane and trastuzumab-based therapy. In 2020, trastuzumab deruxtecan (T-DXd) was the second approved ADC for patients who had received at least 2 lines of anti-HER2-based therapy in the metastatic setting. The success of these two agents has transformed the treatment of HER2-positive breast cancer and has re-energized the field of ADC development. Given their advanced pharmaceutical properties, next-generation HER2-targeted ADCs have the potential to be active beyond traditional HER2-positive breast cancer and may be effective in cells with low expression of HER2 or ERBB2 mutations, opening a spectrum of new possible clinical applications. Ongoing challenges include improving target-specificity, optimizing the toxicity profile, and identifying biomarkers for patient selection. The aim of this review is to summarize the principal molecular, clinical, and safety characteristics of approved and experimental anti-HER2 ADCs, contextualizing the current and future landscape of drug development.

SUBMITTER: Ferraro E

PROVIDER: S-EPMC8356386 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:The growing need for palliative care (PC) among patients with serious illness is outstripped by the short supply of PC specialists. This mismatch calls for competency of all health care providers in primary PC, including patient-centered communication, management of pain and other symptoms, and interprofessional teamwork. Simulation-based medical education (SBME) has emerged as a promising modality to teach key skills and close the educational gap. This paper describes the current state of SBME in training of PC skills. Methods:We conducted a systematic review of the literature reporting on simulation experiences addressing PC skills for clinical learners in medicine and nursing. We collected data on learner characteristics, the method and content of the simulation, and outcome assessments. Results:In a total of 78 studies, 76% involved learners from medicine and 38% involved learners from nursing, while social work (6%) and spiritual care (3%) learners were significantly underrepresented. Only 16% of studies involved collaboration between participants at different training levels. The standardized patient encounter was the most popular simulation method, accounting for 68% of all studies. Eliciting treatment preferences (50%), delivering bad news (41%), and providing empathic communication (40%) were the most commonly addressed skills, while symptom management was only addressed in 13% of studies. The most common method of simulation evaluation was subjective participant feedback (62%). Only 4% of studies examined patient outcomes. In 22% of studies, simulation outcomes were not measured at all. Discussion:We describe the current state of SBME in PC education, highlighting advances over recent decades and identifying gaps and opportunities for future directions. We recommend designing SBME for a broader range of learners and for interprofessional skill building. We advocate for expansion of skill content, especially symptom management education. Finally, evaluation of SBME in PC training should be more rigorous with a shift to include more patient outcomes.

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Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.

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