| Guideline statement | LoE/GoR | Consensus |
|---|---|---|
| The management of ABC is complex and, therefore, involvement of all appropriate specialties in a multidisciplinary team (including but not restricted to medical, radiation, surgical oncologists, imaging experts, pathologists, gynaecologists, psycho-oncologists, social workers, nurses and palliative care specialists), is crucial. | Expert opinion/A | 100% |
| From the time of diagnosis of ABC, patients should be offered appropriate psychosocial care, supportive care and symptom-related interventions as a routine part of their care. The approach must be personalised to meet the needs of the individual patient. | Expert opinion/A | 100% |
| Following a thorough assessment and confirmation of ABC, the potential treatment goals of care should be discussed. Patients should be told that ABC is incurable but treatable, and that some patients can live with ABC for extended periods of time (many years in some circumstances). | Expert opinion/A | 97% |
| This conversation should be conducted in the accessible language, respecting patient privacy and cultural differences, and whenever possible, written information should be provided. | Expert opinion/A | 97% |
| All ABC patients should be offered comprehensive, culturally sensitive, up-to-date and easy-to-understand information about their disease and its management. | I/A | 97% |
| Patients (and their families, caregivers or support network, if the patient agrees) should be invited to participate in the decision-making process at all times. When possible, patients should be encouraged to be accompanied by persons who can support them and share treatment decisions (e.g. family members, caregivers, support network). | Expert opinion/A | 100% |
Every ABC patient must have access to optimal cancer treatment and supportive care according to the highest standards of patient-centred care, as defined by:
|
Expert opinion/A | 100% |
| Every ABC patient should: | ||
| • Have access to the most up-to-date treatments and to innovative therapies at accessible Breast Units/Centres. | Expert opinion/A | 100% |
| • Be treated in Specialist Breast Units/Centres/Services (SBUs) by a specialised multidisciplinary team including specialised side effects management and a nurse experienced in the treatment of ABC. | I/A | |
| • Survivorship issues and palliative care should be addressed and offered at an early stage. | Expert opinion/A | |
| • A quality assurance programme covering the entire breast cancer pathway from screening and diagnosis to treatment, rehabilitation, follow-up and palliative care including services and support for ABC patients and their caregivers, should be implemented by SBUs. | Expert opinion/B | |
| General: QoL | ||
| Strong consideration should be given to the use of validated PROMs for patients to record the symptoms of disease and side effects of treatment experienced as a regular part of clinical care. These PROMs should be simple and user-friendly to facilitate their use in clinical practice, and thought needs to be given to the easiest collection platform, e.g. tablets or smartphones. Systematic monitoring would facilitate communication between patients and their treatment teams by better characterising the toxicities of all anticancer therapies. This would permit early intervention of supportive care services enhancing QoL. | I/C | 87% |
| Specific tools for evaluation of QoL in ABC patients should be developed. | Expert opinion/A | 100% |
| Until then, trials evaluating QoL in this setting should use standardised PROs (instead of focusing exclusively on CTCAEs) and incorporate specific site and treatment specific modules or subscales that exist both in the EORTC and FACT systems. | Expert opinion/A | 100% |
| Additionally, attention needs to be paid to collection methods, timing of assessments and handling of missing data. More sophisticated statistics should also be employed to ensure that clinicians have better, reliable data to help patients when choosing between treatment options. | Expert opinion/A | 100% |
| General: clinical trials | ||
| There are few proven standards of care in ABC management. After appropriate informed consent, inclusion of patients in well-designed, prospective, independent trials must be a priority whenever such trials are available, and the patient is willing to participate. | Expert opinion/A | 100% |
| The ABC community strongly calls for clinical trials addressing important unanswered clinical questions in this setting, and not just for regulatory purposes. Clinical trials should continue to be carried out, even after approval of a new treatment, providing real world data on its performance, efficacy and toxicity. | Expert opinion/A | 100% |
| General: affordability/cost-effectiveness | ||
| The medical community is aware of the problems raised by the cost of ABC treatment. Balanced decisions should be made in all instances; patients’ well-being, length of life and preferences should always guide decisions. | Expert opinion/A | 100% |
| We strongly recommend the use of objective scales, such as the ESMO-MCBS or the ASCO Value Framework, to evaluate the real magnitude of benefit provided by a new treatment and help prioritise funding, particularly in countries with limited resources. | Expert opinion/A | 88% |
| The ABC community strongly supports the use of BIOSIMILARS both for treatment of breast cancer (i.e. trastuzumab) and for supportive care (i.e. growth factors). To be used, the biosimilar must be approved after passing the stringent development and validation processes required by the EMA or the FDA or other similarly strict authority. | I/A | 90% |
| General: survivorship | ||
| As survival is improving in many patients with ABC, consideration of survivorship issues should be part of the routine care of these patients. Health professionals should therefore be ready to change and adapt treatment strategies to disease status, treatment adverse effects and QoL, patients’ priorities and life plans. Attention to chronic needs for home and family care, job and social requirements should be incorporated in the treatment planning and periodically updated. | Expert opinion/A | 95% |
| ABC patients who desire to work or need to work for financial reasons should have the opportunity to do so, with needed and reasonable flexibility in their working schedules to accommodate continuous treatment and hospital visits. | Expert opinion/A | 100% |
| ABC patients with stable disease, being treated as a ‘chronic condition’, should have the option to undergo breast reconstruction if clinically appropriate. | Expert opinion/B | 82% |
| In ABC patients with long-standing stable disease, screening breast imaging should be an option. | Expert opinion/C | Yes: 53% |
| No: 47% | ||
| Breast imaging should also be carried out when there is a suspicion of locoregional progression. | I/A | 100% |
| Fertility preservation: the impact of the anticancer therapies on fertility should be discussed with all women with ABC of childbearing age and their partners, before the start of treatment. The discussion must also include appropriate information about the prognosis of the disease and the potential consequences of pregnancy (e.g. stopping ongoing treatment). | Expert opinion/B | 100% |
| General: other | ||
| Specialised oncology nurses (if possible specialised breast nurses) should be part of the multidisciplinary team managing ABC patients. In some countries, this role may be played by a physician assistant or another trained and specialised healthcare practitioner. | Expert opinion/A | 92% |
| The use of TELEMEDICINE in oncology to help management of patients with ABC living in remote places is an important option to consider when geographic distances are a problem and provided that issues of connectivity are solved. | Expert opinion/B | 93% |
In green, NEW ABC 4 statements.
ABC, advanced breast cancer; ASCO, American Society of Clinical Oncology; Consensus, percentage of panel members in agreement with the statement; CTCAE, Common Terminology Criteria for Adverse Events; EMA, European Medicines Agency; EORTC, European Organisation for Research and Treatment of Cancer; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; FACT, Functional Assessment of Cancer Therapy; FDA, Food and Drug Administration; GoR, grade of recommendation; LoE, available level of evidence; PRO, patient-reported outcome; PROM, patient-reported outcome measure; QoL, quality of life.