•This ESMO Clinical Practice Guideline provides key recommendations and algorithms for managing metastatic breast cancer.•It covers diagnosis, staging, risk assessment, treatment, disease monitoring, ...palliative care and the patient perspective.•ESMO-MCBS and ESCAT scores are given to describe the levels of evidence for treatment choices.•The authors comprise an international expert group, with recommendations based on available evidence and expert opinion.•In clinical practice, all recommendations provided need to be discussed with patients in a shared decision-making approach.
The 4th International Consensus Conference for Breast Cancer in Young Women (BCY4) took place in October 2018, in Lugano, Switzerland, organized by the European School of Oncology (ESO) and the ...European Society of Medical Oncology (ESMO). Consensus recommendations for the management of breast cancer in young women were updated from BCY3 with incorporation of new evidence to inform the guidelines. Areas of research priorities were also identified. This article summarizes the ESO–ESMO international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
•Breast cancer in young women should be treated based on stage and biology of disease.•Management of breast cancer in young women requires special considerations including psychological, reproductive and genetic.•Breast cancer in young women necessitates multi-disciplinary care at diagnosis, during treatment and during survivorship.
We dedicate this manuscript in memory of a dear friend and colleague Bella Kaufman.
The fifth International Consensus Symposium for Breast Cancer in Young Women (BCY5) took place virtually in October ...2020, organized by the European School of Oncology (ESO) and the European Society of Medical Oncology (ESMO). Consensus recommendations for the management of breast cancer in young women were updated from BCY4 with incorporation of new evidence to inform the guidelines. Areas of research priorities as well as specificities in different geographic and minority populations were identified. This manuscript summarizes the ESO–ESMO international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
•Breast cancer in young women encompasses unique treatment and survivorship considerations.•Fertility, ovarian function suppression and premature menopause are major issues that need to be addressed.•The presence of a germline pathogenic variant impacts risk reduction measures, local management and systemic therapy.•Research on how new systemic therapies impact fertility and ovarian function is urgently needed.
•This ESMO Clinical Practice Guideline provides key recommendations and algorithms for the management of patients with EBC.•It covers diagnosis, staging, risk assessment, treatment, follow-up, ...specific situations and the patient perspective.•The author group is multidisciplinary, with experts representing a range of institutions worldwide.•Recommendations, including ESMO-MCBS and ESCAT scores where applicable, are based on available evidence and expert opinion.•Patient communication and shared decision making are covered with respect to diagnostic procedures and treatment options.
The landscape of clinical trials testing risk-adapted modulations of cancer treatments is complex. Multiple trial designs, endpoints, and thresholds for non-inferiority have been used; however, no ...consensus or convention has ever been agreed to categorise biomarkers useful to inform the treatment intensity modulation of cancer treatments.
An expert subgroup under the European Society for Medical Oncology (ESMO) Precision Medicine Working Group shaped an international collaborative project to develop a classification system for biomarkers used in the cancer treatment de-intensification, based on a tiered approach. A group of disease-oriented clinical, translational, methodology and public health experts, and patients’ representatives provided an analysis of the status quo, and scanned the horizon of ongoing clinical trials. The classification was developed through multiple rounds of expert revisions and inputs.
The working group agreed on a univocal definition of treatment de-intensification. Evidence of reduction in the dose-density, intensity, or cumulative dose, including intermittent schedules or shorter treatment duration or deletion of segment(s) of the standard regimens, compound(s), or treatment modality must be demonstrated, to define a treatment de-intensification. De-intensified regimens must also portend a positive impact on toxicity, quality of life, health system burden, or financial toxicity. ESMO classification categorises the biomarkers for treatment modulation in three tiers, based on the level of evidence. Tier A includes biomarkers validated in prospective, randomised, non-inferiority clinical trials. The working group agreed that in non-inferiority clinical trials, boundaries are highly dependent upon the disease scenario and endpoint being studied and that the absolute differences in the outcomes are the most relevant measures, rather than relative differences. Biomarkers tested in single-arm studies with a threshold of non-inferiority are classified as Tier B. Tier C is when the validation occurs in prospective-retrospective quality cohort investigations.
ESMO classification for the risk-guided intensity modulation of cancer treatments provides a set of evidence-based criteria to categorise biomarkers deemed to inform de-intensification of cancer treatments, in risk-defined patients. The classification aims at harmonising definitions on this matter, therefore offering a common language for all the relevant stakeholders, including clinicians, patients, decision-makers, and for clinical trials.
•The landscape of clinical trials testing risk-adapted modulations of cancer treatments is complex.•Several trial designs and endpoints are used to evaluate de-intensified cancer therapies.•ESMO has developed a classification to categorise biomarkers to inform risk-guided intensity modulation of cancer treatments.•The classification includes three tiers, based on the clinical trial methodology and results.•The ESMO classification will help harmonise definitions, thereby facilitating communication with all relevant stakeholders.
After a diagnosis of unilateral breast cancer, increasing numbers of patients are requesting contralateral prophylactic mastectomy (CPM), the surgical removal of the healthy breast after diagnosis of ...unilateral breast cancer. It is important for the community of breast cancer specialists to provide meaningful guidance to women considering CPM. This manifesto discusses the issues and challenges of CPM and provides recommendations to improve oncological, surgical, physical and psychological outcomes for women presenting with unilateral breast cancer: (1) Communicate best available risks in manageable timeframes to prioritise actions; better risk stratification and implementation of risk-assessment tools combining family history, genetic and genomic information, and treatment and prognosis of the first breast cancer are required; (2) Reserve CPM for specific situations; in women not at high risk of contralateral breast cancer (CBC), ipsilateral breast-conserving surgery is the recommended option; (3) Encourage patients at low or intermediate risk of CBC to delay decisions on CPM until treatment for the primary cancer is complete, to focus on treating the existing disease first; (4) Provide patients with personalised information about the risk:benefit balance of CPM in manageable timeframes; (5) Ensure patients have an informed understanding of the competing risks for CBC and that there is a realistic plan for the patient; (6) Ensure patients understand the short- and long-term physical effects of CPM; (7) In patients considering CPM, offer psychological and surgical counselling before surgery; anxiety alone is not an indication for CPM; (8) Eliminate inequality between countries in reimbursement strategies; CPM should be reimbursed if it is considered a reasonable option resulting from multidisciplinary tumour board assessment; (9) Treat breast cancer patients at specialist breast units providing the entire patient-centred pathway.
Recommendations 1. Communicate the best available risks in manageable timeframes to prioritise actions; better risk stratification and implementation of risk-assessment tools combining family history, genetic and genomic information, and treatment and prognosis of the first breast cancer are required 2. Reserve CPM for specific situations; in women not at high risk of CBC, ipsilateral breast-conserving surgery is the recommended option 3. Encourage patients at low or intermediate risk of CBC to delay decisions on CPM until treatment for the primary cancer is complete, to focus on treating the existing disease first 4. Provide patients with personalised information about the risk:benefit balance of CPM in manageable timeframes 5. Ensure patients have an informed understanding of the competing risks for CBC and that there is a realistic plan for the patient 6. Ensure patients understand the short- and long-term physical effects of CPM 7. In patients considering CPM, offer psychological and surgical counselling before surgery; anxiety alone is not an indication for CPM 8. Eliminate inequality between countries in reimbursement strategies; CPM should be reimbursed if it is considered a reasonable option resulting from multidisciplinary tumour board assessment 9. Treat breast cancer patients at specialist breast units providing the entire patient-centred pathway Display omitted
•Increasingly, patients diagnosed with unilateral breast cancer request CPM.•Here, a multidisciplinary panel of breast cancer experts provides guidance on CPM.•Patients should be counselled and treated at specialist breast centres.•Patients need to understand competing risks for contralateral breast cancer.•Patients need personalised information about CPM risk:benefit and a realistic plan.
Genomic tumour profiling has a crucial role in the management of patients with solid cancers, as it helps selecting and prioritising therapeutic interventions based on prognostic and predictive ...biomarkers, as well as identifying markers of hereditary cancers. Harmonised approaches to interpret the results of genomic testing are needed to support physicians in their decision making, prevent inequalities in precision medicine and maximise patient benefit from available cancer management options.
The European Society for Medical Oncology (ESMO) Translational Research and Precision Medicine Working Group assembled a group of international experts to propose recommendations for preparing clinical genomic reports for solid cancers. These recommendations aim to foster best practices in integrating genomic testing within clinical settings. After review of available evidence, several rounds of surveys and focused discussions were conducted to reach consensus on the recommendation statements. Only consensus recommendations were reported. Recommendation statements were graded in two tiers based on their clinical importance: level A (required to maintain common standards in reporting) and level B (optional but necessary to achieve ideal practice).
Genomics reports should present key information in a front page(s) followed by supplementary information in one or more appendices. Reports should be structured into sections: (i) patient and sample details; (ii) assay and data analysis characteristics; (iii) sample-specific assay performance and quality control; (iv) genomic alterations and their functional annotation; (v) clinical actionability assessment and matching to potential therapy indications; and (vi) summary of the main findings. Specific recommendations to prepare each of these sections are made.
We present a set of recommendations aimed at structuring genomics reports to enhance physician comprehension of genomic profiling results for solid cancers. Communication between ordering physicians and professionals reporting genomic data is key to minimise uncertainties and to optimise the impact of genomic tests in patient care.
•These Recommendations cover the preparation of genomic reports to inform clinical decisions for patients with solid cancers.•Recommendations are based on consensus from a multidisciplinary group of experts after reviewing available evidence.•The manuscript provides guidance on structuring genomic reports, and the optimal presentation of content for each section.•These recommendations are relevant to most next-generation sequencing assays utilised in clinical practice and research.•Recommendations are categorised into priority levels (A, B) to adapt to diverse clinical and laboratory contexts.
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