4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)
Authors: F. Cardoso, E. Senkus, A. Costa, E. Papadopoulos, M. Aapro, F. André, N. Harbeck, B. Aguilar Lopez, C.H. Barrios, J. Bergh, L. Biganzoli, C.B. Boers-Doets, M.J. Cardoso, L.A. Carey, J. Cortés, G. Curigliano, V. Diéras, N.S. El Saghir, A. Eniu, L. Fallowfield, P.A. Francis, K. Gelmon, S.R.D. Johnston, B. Kaufman, S. Koppikar, I.E. Krop, M. Mayer, G. Nakigudde, B.V. Offersen, S. Ohno, O. Pagani, S. Paluch-Shimon, F. Penault-Llorca, A. Prat, H.S. Rugo, G.W. Sledge, D. Spence, C. Thomssen, D.A. Vorobiof, B. Xu, L. Norton, E.P. Winer
Journal: Annals of Oncology (2018)

Advanced Breast Cancer (ABC) comprises both locally advanced breast cancer (LABC) and metastatic breast cancer (MBC) [1.Cardoso F. Costa A. Norton L. ESO-ESMO 2nd International Consensus Guidelines for Advanced Breast Cancer (ABC2). Simultaneous publication in.Breast. 2014; 23: 489-502Abstract Full Text Full Text PDF PubMed Scopus (252) Google Scholar]. Although treatable, MBC remains virtually an incurable disease with a median overall survival (OS) of ∼3 years and a 5-year survival of only ∼25% [2.Cardoso F. Spence D. Mertz S. et al.Global analysis of advanced/metastatic breast cancer: decade report (2005–2015).Breast. 2018; 39: 131-138Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar, 3.N Howlader, AM Noone, M Krapcho et al (eds). SEER Cancer Statistics Review, 1975–2013. Bethesda, MD: National Cancer Institute. http://seer.cancer.gov/csr/1975_2013/, based on November 2015 SEER data submission, posted to the SEER web site, April 2016.Google Scholar]. The MBC Decade Report [2.Cardoso F. Spence D. Mertz S. et al.Global analysis of advanced/metastatic breast cancer: decade report (2005–2015).Breast. 2018; 39: 131-138Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar] shows that progress has been slow in terms of improved outcomes, quality of life (QoL), awareness and information regarding ABC. More recently, some studies seem to indicate an improvement in OS, mostly due to advances in human epidermal growth factor receptor 2 (HER2)-positive ABC [4.Sundquist M. Brudin L. Tejler G. Improved survival in metastatic breast cancer 1985–2016.Breast. 2017; 31: 46-50Abstract Full Text Full Text PDF PubMed Scopus (107) Google Scholar, 5.Kobayashi K. Ito Y. Matsuura M. et al.Impact of immunohistological subtypes on the long-term prognosis of patients with metastatic breast cancer.Surg Today. 2016; 46: 821-826Crossref PubMed Scopus (28) Google Scholar, 6.Fietz T. Tesch H. Rauh J. et al.Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer—results from the prospective German TMK cohort study.Breast. 2017; 34: 122-130Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar]. The better survival is seen in an environment with access to the best available care and particularly in de novo ABC, while recurrent ABC seems to become harder to manage [7.Malmgren J.A. Mayer M. Atwood M.K. Kaplan H.G. Differential presentation and survival of de novo and recurrent metastatic breast cancer over time: 1990–2010.Breast Cancer Res Treat. 2018; 167: 579-590Crossref PubMed Scopus (72) Google Scholar, 8.Hölzel D. Eckel R. Bauerfeind I. et al.Improved systemic treatment for early breast cancer improves cure rates, modifies metastatic pattern and shortens post-metastatic survival: 35-year results from the Munich Cancer Registry.J Cancer Res Clin Oncol. 2017; 143: 1701-1712Crossref PubMed Scopus (26) Google Scholar]. The last decade has seen an improvement in the levels of evidence (LoEs) used for many of the ABC recommendations, however, still far from the LoEs existing for the majority of early breast cancer guidelines. More and better, more innovatively designed trials are urgently needed, in particular to address clinically important questions, not necessarily related to a specific therapeutic agent. The use of real world evidence and the application of big data analysis to oncology may soon become important additional pathways to acquire the necessary LoEs. At the research level, efforts continue to better understand the biology and heterogeneity of ABC, as well as mechanisms of tumour resistance and biomarkers predictive of response to the different therapeutic options. However, the majority of the recent research highlights are not yet ready for routine clinical practice implementation. The 4th International Consensus Conference for ABC (ABC 4) took place in Lisbon, Portugal on 2–4 November 2017, bringing together 1300 participants from 88 countries, including health professionals, patient advocates and journalists. Its primary aim is the development of international consensus guidelines for the management of ABC patients. These guidelines are based on the most up-to-date evidence and can be used to guide treatment decision making in many different healthcare settings globally, with the necessary adaptations due to different access to care. The ABC guidelines are developed as a joint effort from ESO and ESMO and are endorsed by EUSOMA (European Society of Breast Cancer Specialists), ESTRO (European Society of Radiation Oncology), UICC (Union for International Cancer Control), SIS (Senologic International Society) and Flam (FederatiónLatinoAmericana de Mastologia). There was also official representation of ASCO (American Society of Clinical Oncology) in the consensus panel. The ABC 4 Conference was also organised under the auspices of OECI (Organization of European Cancer Institutes) and with the support of the BCRF (Breast Cancer Research Foundation) and the Susan G Komen for the Cure. The present manuscript summarises the guidelines developed at ABC 4 and is supported with the LoEs, grades of recommendation (GoRs), percentages of consensus reached at the Conference and supporting references. In addition, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) was applied to new European Medicines Agency (EMA)-approved drugs [9.Cherny N.I. Dafni U. Bogaerts J. et al.ESMO-Magnitude of Clinical BenefitScale version 1.1.Ann Oncol. 2017; 28: 2340-2366Abstract Full Text Full Text PDF PubMed Scopus (325) Google Scholar], and ESMO-MCBS scores for new therapies/indications are included. ESMO-MCBS version 1.1 (v1.1) [9.Cherny N.I. Dafni U. Bogaerts J. et al.ESMO-Magnitude of Clinical BenefitScale version 1.1.Ann Oncol. 2017; 28: 2340-2366Abstract Full Text Full Text PDF PubMed Scopus (325) Google Scholar] was used to calculate scores for new therapies/indications approved by the EMA since 1 January 2016. Before the ABC 4 Conference, a set of preliminary recommendation statements on the management of ABC were prepared, based on available published data and following the ESMO guidelines methodology. These recommendations were circulated to all 42 panel members by email for comments and corrections on content and wording. A final set of recommendations was presented, discussed and voted upon during the consensus session of ABC 4. All panel members were instructed to vote on all questions, with members with a potential conflict of interest or who did not feel comfortable answering the question (e.g. due to lack of expertise in a particular field) instructed to vote 'abstain'. A new possible answer was included in the Precision Medicine statements: 'Insufficient data', which should be selected if the panel member believes the existent data were not enough to vote 'yes' or 'no', highlighting an area where research is needed. Additional changes in the wording of statements were made during the session. The statements related to management of side effects and difficult symptoms, included under the Supportive and Palliative Care section, were not voted on during the consensus session, but discussed and unanimously agreed by email, and are considered to have 100% agreement. Previous ABC recommendations that did not require update or only minor changes were not re-voted but were reviewed by all panel members by email and remain valid. To provide a full overview of all ABC guidelines currently approved, the authors have listed all recommendations per subject, highlighting those that were discussed, voted and approved in ABC 4. supplementary Table S1, available at Annals of Oncology online, describes the new grading system used, as per ESMO guidelines methodology, adapted from [10.Dykewicz C.A. Summary of the guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients.Clin Infect Dis. 2001; 33: 139-144Crossref PubMed Scopus (422) Google Scholar]; see http://www.esmo.org/Guidelines/ESMO-Guidelines-Methodology. supplementary Table S2, available at Annals of Oncology online, lists all members of the ABC 4 consensus panel and their disclosures of any relationships with the pharmaceutical industry that could be perceived as a potential conflict of interest. supplementary Figures, available at Annals of Oncology online, features updated ABC diagnostic and treatment algorithms. Slides with all ABC guidelines statements are available online at http://www.abc-lisbon.org/ and http://oncologypro.esmo.org/Guidelines/ESMO-Consensus-Conferences/Breast-Cancer. Tabled 1Guideline statementLoE/GoRConsensusVisceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since another treatment option at progression will probably not be possible.Expert opinion/n/a95%Primary endocrine resistance is defined as relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of first-line ET for ABC, while on ET.Expert opinion/n/a67%Secondary endocrine resistance is defined as relapse while on adjuvant ET but after the first 2 years, or relapse within 12 months of completing adjuvant ET, or PD ≥ 6 months after initiating ET for ABC, while on ET.Expert opinion/n/a67%Oligometastatic disease is defined as low volume metastatic disease with limited number and size of metastatic lesions (up to 5 and not necessarily in the same organ), potentially amenable for local treatment, aimed at achieving a complete remission status.Expert opinion/n/a78%Patients with multiple chronic conditions are defined as patients with additional comorbidities (e.g. cardiovascular, impaired renal or liver function, autoimmune disease) making it difficult to account for all of the possible extrapolations to develop specific recommendations for care.Expert opinion/n/a100%Adequate OFS in the context of ABC:Adequate OFS for ABC pre-menopausal patients can be obtained through bilateral ovariectomy, continuous use of LHRH agonists or OFA through pelvic RT (this latter is not always effective and therefore is the least preferred option).I/A85%If a LHRH agonist is used in this age group, it should usually be given on a q4w basis to guarantee optimal OFS.II/B85%Efficacy of OFS must be initially confirmed analytically through serial evaluations of serum oestradiol, even in the presence of amenorrhoea, especially if an AI is administered.Expert opinion/ B85%As all endocrine interventions for pre-menopausal patients with endocrine-responsive ABC require indefinite OFS, choosing one method over the other requires balance of patient's wish for potentially preserving fertility, compliance with frequent injections over a long period of time and cost.Expert opinion/ B85%Maintenance therapy: in the context of ABC Guidelines, maintenance therapy refers to the continuation of anti-HER2 therapy and/or ET after discontinuation of ChT.Expert opinion/n/a100%Integrative medicine: complementary and integrative medicine (CIM) represents the use of complementary treatments side by side with conventional approaches in a proper therapeutic environment.Expert opinion/n/a100%In green, NEW ABC 4 statements.ABC, advanced breast cancer; AI, aromatase inhibitor; Consensus, percentage of panel members in agreement with the statement; ChT, chemotherapy; ET, endocrine therapy; GoR, grade of recommendation; HER2, human epidermal growth factor 2; LHRH, luteinising hormone-releasing hormone; LoE, available level of evidence; OFA, ovarian function ablation; OFS, ovarian function suppression; PD, disease progression; q4w, every 4 weeks; RT, radiotherapy. Open table in a new tab In green, NEW ABC 4 statements. ABC, advanced breast cancer; AI, aromatase inhibitor; Consensus, percentage of panel members in agreement with the statement; ChT, chemotherapy; ET, endocrine therapy; GoR, grade of recommendation; HER2, human epidermal growth factor 2; LHRH, luteinising hormone-releasing hormone; LoE, available level of evidence; OFA, ovarian function ablation; OFS, ovarian function suppression; PD, disease progression; q4w, every 4 weeks; RT, radiotherapy. Following the effort to standardise definitions and homogenise the use of certain medical terms, ABC 4 provides three additional definitions. Adequate ovarian function suppression (OFS) or ablation (OFA) is a somewhat controversial but crucial issue in the treatment of pre-menopausal patients with oestrogen receptor (ER)-positive ABC. As already extensively discussed in previous editions, the main recommendation for these patients is the induction of OFS/OFA, to which an additional endocrine agent should be added [1.Cardoso F. Costa A. Norton L. ESO-ESMO 2nd International Consensus Guidelines for Advanced Breast Cancer (ABC2). Simultaneous publication in.Breast. 2014; 23: 489-502Abstract Full Text Full Text PDF PubMed Scopus (252) Google Scholar, 11.Cardoso F. Costa A. Senkus E. et al.ESO-ESMO 3rd International Consensus Guidelines for Advanced Breast Cancer (ABC 3).Simultaneous publication in: Breast. 2017; 31: 244-259Scopus (157) Google Scholar]. The method for inducing OFS or OFA may vary due to patient's preferences, logistical and financial issues. Bilateral salpingo-oophorectomy by a minimal invasive approach is a reasonable option and should be discussed with patients. The confirmation that ovarian function is adequately suppressed when chemically induced [i.e. luteinising hormone-releasing hormone (LHRH) agonist] is not always straightforward but it is indispensable if an aromatase inhibitor (AI) is given concomitantly, in view of the oestrogen-inducing effect of these agents in the absence of OFS. The best way to obtain this confirmation [i.e. testing oestradiol levels with or without levels of luteinising hormone (LH) and follicle-stimulating hormone (FSH)] and the timing and frequency of confirmation tests are not well established and there was substantial discussion among panel members. It was decided, as a compromise, to recommend serial measures of serum oestradiol during the initial months of treatment with an AI + LHRH agonist. When a LHRH agonist is used, the majority of the panel recommends the use of the q4w (every 4 weeks) regimen. There are, however, some recent data regarding the use of the 3-monthly regimen with concurrent tamoxifen that yielded similar results in terms of pharmacodynamic and safety profiles [12.Noguchi S. Kim H.J. Jesena A. et al.Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer.Breast Cancer. 2016; 23: 771-779Crossref PubMed Scopus (16) Google Scholar, 13.Masuda N. Iwata H. Rai Y. et al.Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer.Breast Cancer Res Treat. 2011; 126: 443-451Crossref PubMed Scopus (22) Google Scholar] in two randomised trials of 222 and 170 patients, respectively, and may, therefore, be considered a valid option when combined with tamoxifen for selected patients. Tabled 1Guideline statementLoE/GoRConsensusThe 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/A100%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/A100%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/A97%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/A97%All ABC patients should be offered comprehensive, culturally sensitive, up-to-date and easy-to-understand information about their disease and its management.I/A97%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/A100%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:•Open communication between patients and their cancer care teams as a primary goal.•Educating patients about treatment options and supportive care, through development and dissemination of evidence-based information in a clear, culturally appropriate form.•Encouraging patients to be proactive in their care and to share decision making with their healthcare providers.•Empowering patients to develop the capability of improving their own QoL within their cancer experience.•Always taking into account patient preferences, values and needs as essential to optimal cancer care.Expert opinion/A100%Every ABC patient should:• Have access to the most up-to-date treatments and to innovative therapies at accessible Breast Units/Centres.Expert opinion/A100%• 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/BGeneral: QoLStrong 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/C87%Specific tools for evaluation of QoL in ABC patients should be developed.Expert opinion/A100%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/A100%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/A100%General: clinical trialsThere 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/A100%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/A100%General: affordability/cost-effectivenessThe 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/A100%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/A88%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/A90%General: survivorshipAs 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/A95%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/A100%ABC patients with stable disease, being treated as a 'chronic condition', should have the option to undergo breast reconstruction if clinically appropriate.Expert opinion/B82%In ABC patients with long-standing stable disease, screening breast imaging should be an option.Expert opinion/CYes: 53%No: 47%Breast imaging should also be carried out when there is a suspicion of locoregional progression.I/A100%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/B100%General: otherSpecialised 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/A92%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/B93%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. Open table in a new tab 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. The majority of general recommendations from previous ABC conferences still stand as all available new data reinforces the guidelines and, in some cases, increases the LoE and/or GoR. Access to the best available therapies as well as treatment by a specialised and multidisciplinary team are crucial to achieve the best outcomes. However, access to treatments is very heterogeneous between different countries and within each country, depending largely on financial, reimbursement and coverage issues. All guidelines that are related to a certain treatment depend, obviously, on the availability of that treatment. In all ABC guidelines, when 'preferred option' or 'standard of care' terms are used, they assume availability of the agent(s) discussed. Currently, some efforts are being made to adapt the ABC Guidelines to different environments, such as Africa, South America and Asia, but these are separate projects, outside the scope of the main guidelines and this manuscript. One possible way to minimise the issue of cost is the use of biosimilars. In line with the ESMO position [14.Tabernero J. Vyas M. Giuliani R. et al.Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers.ESMO Open. 2017; 1: e000142Abstract Full Text Full Text PDF PubMed Scopus (97) Google Scholar], 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). Importantly, only those biosimilars that pass the stringent development and validation processes required by the EMA or the Food and Drug Administration (FDA) or other similarly strict authority should be used. Additionally, in order to lead to a significant economic impact and making treatment available to more patients with breast cancer, the price of biosimilars should be substantially lower than the original compounds. Accessibility to multidisciplinary care is also very uneven throughout the world, for all cancer patients but particularly for advanced cancer patients, who usually continue to be managed by a single isolated physician. In Europe, the fight for the establishment of Specialised Breast Units/Centres/Services (SBUs) has been long and slow, with scattered implementation despite recommendations from the European Parliament for the last decade [15.Cardoso F. Cataliotti L. Costa A. et al.European Breast Cancer Conference manifesto on breast centres/units.Eur J Cancer. 2017; 72: 244-250Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar]. Fortunately, some ABC patients can now live several years, especially those who achieve long-lasting complete remissions. This is more frequent in situations of oligometastatic disease or with HER2-positive disease. Survivorship issues have therefore started to be discussed also for ABC patients. A highly sensitive issue is fertility preservation and motherhood in ABC patients. Every patient has the right to be informed about the potential negative impact on fertility of anticancer therapies. This is particularly complex for luminal ABC where induction of OFS or OFA is the mainstay of therapy. If a desire for pregnancy exists or if pregnancy inadvertently occurs, a delicate and thorough discussion should occur with the patient and partner regarding the long-term prognosis of the disease and the potential consequences of stopping any ongoing therapy. However, after full information, the final decision lays with the patient and should be respected [16.Peccatori F.A. Azim Jr, H.A. Orecchia R. et al.Cancer, pregnancy and fertility: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.Ann Oncol. 2013; 24: vi160-vi170Abstract Full Text Full Text PDF PubMed Scopus (486) Google Scholar, 17.Ethics Committee of American Society for Reproductive Medicine Fertility preservation and reproduction in patients facing gonadotoxic therapies: a committee opinion.Fertil Steril. 2013; 100: 1224-1231Abstract Full Text Full Text PDF PubMed Scopus (220) Google Scholar, 18.Loren A.W. Mangu P.B. Beck L.N. et al.Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update.J Clin Oncol. 2013; 31: 2500-2510Crossref PubMed Scopus (1126) Google Scholar, 19.Walsh S.K. Ginsburg E.S. Lehmann L.S. Partridge A.H. Oncofertility: fertile ground for conflict between patient autonomy and medical values.Oncologist. 2017; 22: 860-863Crossref PubMed Scopus (6) Google Scholar]. Discussions about the risk/benefits of different further active anticancer treatments in ABC can be challenging, especially if the drugs offered might not reduce symptom burden or prolong survival but do have significant toxicities. Patients need good information, collected systematically with reliable tools, about likely harms and benefits to enable balanced decision making. Although more trials of novel therapies do now build in health-related QoL (HRQoL) assessment, many publications still give precedence to physician rec