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Background: Lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals with cancer have specific and unique health issues and needs. Reports persist of inequalities in the care provided for these patients, making it important to assess the attitudes and knowledge of LGBTQ needs among those who provide care., Materials and Methods: The European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOP Europe) Adolescents and Young Adults Working Group designed this survey comprising 67 questions covering demographics, knowledge, and education of LGBTQ health needs, and attitudes regarding LGBTQ patients with cancer., Results: Among the 672 respondents, a majority do not ask about sexual orientation and gender identity during first visit (64% and 58%, respectively). Only a minority of the respondents considered themselves well informed regarding gay/lesbian and transgender patients' health (44% and 25%, respectively) and psychosocial needs (34%). There was high interest in receiving education regarding the unique health needs of LGBTQ patients (73%)., Conclusions: Survey respondents indicated a willingness to provide care to LGBTQ patients, but a lack of confidence in the knowledge of the health issues and needs of LGBTQ individuals. Lack of training provided in medical schools and postgraduate training programmes and strong interest for additional education on these issues were reported., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Financial toxicity, defined as both the objective financial burden and subjective financial distress from a cancer diagnosis and its treatment, is a topic of interest in the assessment of the quality of life of patients with cancer and their families. Current evidence implicates financial toxicity in psychosocial, economic and other harms, leading to suboptimal cancer outcomes along the entire trajectory of diagnosis, treatment, supportive care, survivorship and palliation. This paper presents the results of a virtual consensus, based on the evidence base to date, on the screening and management of financial toxicity in patients with and beyond cancer organized by the European Society for Medical Oncology (ESMO) in 2022., Methods: A Delphi panel of 19 experts from 11 countries was convened taking into account multidisciplinarity, diversity in health system contexts and research relevance. The international panel of experts was divided into four working groups (WGs) to address questions relating to distinct thematic areas: patients with cancer at risk of financial toxicity; management of financial toxicity during the initial phase of treatment at the hospital/ambulatory settings; financial toxicity during the continuing phase and at end of life; and financial risk protection for survivors of cancer, and in cancer recurrence. After comprehensively reviewing the literature, statements were developed by the WGs and then presented to the entire panel for further discussion and amendment, and voting., Results and Discussion: A total of 25 evidence-informed consensus statements were developed, which answer 13 questions on financial toxicity. They cover evidence summaries, practice recommendations/guiding statements and policy recommendations relevant across health systems. These consensus statements aim to provide a more comprehensive understanding of financial toxicity and guide clinicians globally in mitigating its impact, emphasizing the importance of further research, best practices and guidelines., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Cancer is a global public health problem, requiring efficient health system investments to deliver sustainable impact on population health. Access to medicines is a critical component of health systems, having a crucial role in delivering therapeutic benefits. Since 1977, the World Health Organization (WHO) has published a Model List of Essential Medicines (EML) that includes key health interventions for the prevention and control of conditions of public health relevance. Essential medicines are selected for inclusion in the EML based on the evidence of efficacy, safety, therapeutic value, and the potential to impact population health. With the rapid changes in the therapeutic landscape of cancer treatment with new medicine approvals, there is a critical need to select and prioritise specific cancer interventions based on their intrinsic value., Materials and Methods: The European Society for Medical Oncology (ESMO) has developed a decisional methodology based on a threshold with a minimum set of technical specifications and a consensus-based procedure for decisions to select candidate cancer medicines to be submitted to the WHO for consideration for the WHO EML., Results: ESMO recognises the WHO EML as an important reference guide for medicines that all countries should include in their national EMLs. Cancer medicines on the WHO EML are used in the treatment of the majority of cancers, and are recommended in the evidence-based ESMO Clinical Practice Guidelines that medical oncologists use to treat patients. ESMO's submissions to the WHO EML in 2019 and 2021 and their respective outcomes are presented in the manuscript., Conclusion: Due to the rising costs associated with newly available therapies, structured, reproducible, and field-tested tools to evaluate the added clinical benefit from these therapies need to be implemented in pre-selecting potential candidate medicines to be included in the WHO EML. ESMO is proud to collaborate closely with WHO on this important global public health initiative., Competing Interests: Disclosure TA reports personal fees from CeCaVa, institutional grants and personal fees from Novartis, institutional grants from NeraCare, personal fees and travel grants from BMS, personal fees and travel grants from Pierre Fabre, institutional grants from Sanofi, institutional grants from SkylineDx and institutional grants from iFIT, outside the submitted work. GC has received personal fees from AstraZeneca and Daiichi Sankyo; has received grants or contracts from Merck and AstraZeneca; has received personal fees as advisory board member for AstraZeneca, BMS; Ellipsis, Merck; Lilly, Pfizer, Roche, Veracyte; has received institutional research grant from Merck; has received institutional funding for phase I studies from Astellas, AstraZeneca, BMS, Blueprint Medicine, Daiichi Sankyo, Kymab, Novartis, Philogen, Roche, Sanofi; has received consulting fees from Roche, BMS, Novartis, Lilly, Pfizer, Seagen, AstraZeneca, Ellipsis, Gilead, Merck, Celcuity, Sanofi, Exact Sciences, and Daiichi Sankyo; has received payment or honoraria for presentations, lectures, speaker bureaus, manuscript writing, or educational events from AstraZeneca, Novartis, Lilly, Pfizer, Seagen, Roche and Daiichi Sankyo; has received support for attending meetings or travel from AstraZeneca and Daiichi Sankyo; has participated on a data safety monitoring board or advisory board for Roche, BMS, Novartis, Lilly, Pfizer, Seagen, Ellipsis, Gilead, Merck, Celcuity, AstraZeneca, and Daiichi Sankyo; has an advisory role and is Member of the Scientific Council of Europa Donna, is an Officer of the Consiglio Superiore di Sanità, Italian National Health Council as Advisor for Ministry of Health, and has an advisory role in Fondazione Beretta Cancer Research Foundation. RG reports being an invited speaker from Apogen, Lilly, Mylan, Novartis, Roche, Pfizer, Medicines for Europe, Mabxience and the European Access Academy (all with no fee received); she received personal fees from AstraZeneca and travel grants form Roche; she reports an advisory role for UICC ATOM Medicines (January 2023); she reports being a full member of the Cancer Drug Development Forum (CDDF); she is co-chair and member of the European Medicines Agency (EMA) Healthcare Professional Working Party (HCPWP) and a member of the EMA Cancer Medicines Forum; she serves as expert for the evaluation of proposals submitted to Horizon Europe Health Cluster-for the Health and Digital Executive Agency (HaDEA). DT reports being a member of the EMA Healthcare Professional Working Party (HCPWP), a member of the WHO SAGE IVD and a member of the WHO EML Cancer Medicines Working Group. GB, MG, NJL and GP are full-time employees of ESMO. All the other authors have declared no conflicts of interest., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: COVID-19 has significantly affected patients with cancer and revealed unanticipated challenges in securing optimal cancer care across different disciplines. The European Society for Medical Oncology COVID-19 and CAncer REgistry (ESMO-CoCARE) is an international, real-world database, collecting data on the natural history, management, and outcomes of patients with cancer and SARS-CoV-2 infection., Methods: This is the 2nd CoCARE analysis, jointly with Belgian (Belgian Society of Medical Oncology, BSMO) and Portuguese (Portuguese Society of Medical Oncology, PSMO) registries, with data from January 2020 to December 2021. The aim is to identify significant prognostic factors for COVID-19 hospitalization and mortality (primary outcomes), as well as intensive care unit admission and overall survival (OS) (secondary outcomes). Subgroup analyses by pandemic phase and vaccination status were carried out., Results: The cohort includes 3294 patients (CoCARE: 2049; BSMO: 928, all hospitalized by eligibility criteria; PSMO: 317), diagnosed in four distinct pandemic phases (January to May 2020: 36%; June to September 2020: 9%; October 2020 to February 2021: 41%; March to December 2021: 12%). COVID-19 hospitalization rate was 54% (CoCARE/PSMO), ICU admission 14%, and COVID-19 mortality 22% (all data). At a 6-month median follow-up, 1013 deaths were recorded with 73% 3-month OS rate. No significant change was observed in COVID-19 mortality among hospitalized patients across the four pandemic phases (30%-33%). Hospitalizations and ICU admission decreased significantly (from 78% to 34% and 16% to 10%, respectively). Among 1522 patients with known vaccination status at COVID-19 diagnosis, 70% were non-vaccinated, 24% had incomplete vaccination, and 7% complete vaccination. Complete vaccination had a protective effect on hospitalization (odds ratio = 0.24; 95% confidence interval [0.14-0.38]), ICU admission (odds ratio = 0.29 [0.09-0.94]), and OS (hazard ratio = 0.39 [0.20-0.76]). In multivariable analyses, COVID-19 hospitalization was associated with patient/cancer characteristics, the first pandemic phase, the presence of COVID-19-related symptoms or inflammatory biomarkers, whereas COVID-19 mortality was significantly higher in symptomatic patients, males, older age, ethnicity other than Asian/Caucasian, Eastern Cooperative Oncology Group performance status ≥2, body mass index <25, hematological malignancy, progressive disease versus no evident disease, and advanced cancer stage., Conclusions: The updated CoCARE analysis, jointly with BSMO and PSMO, highlights factors that significantly affect COVID-19 outcomes, providing actionable clues for further reducing mortality., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Cancer epidemiology is unique in adolescents and young adults (AYAs; aged 15-39 years). The European Society for Medical Oncology/European Society for Paediatric Oncology (ESMO/SIOPE) AYA Working Group aims to describe the burden of cancers in AYAs in Europe and across European Union (EU) countries., Patients and Methods: We used data available on the Global Cancer Observatory. We retrieved crude and age-standardised (World Standard Population) incidence and mortality rates. We reported about AYA cancer burden in Europe and between 28 EU member states. We described incidence and mortality for all cancers and for the 13 cancers most relevant to the AYA population., Results: Incidence and mortality varied widely between countries with the highest mortality observed in Eastern EU countries. Cancers of the female breast, thyroid and male testis were the most common cancers across countries followed by melanoma of skin and cancers of the cervix. Variations in cancer incidence rates across different populations may reflect different distribution of risk factors, variations in the implementation or uptake of screening as well as overdiagnosis. AYA cancer mortality disparities may be due to variation in early-stage diagnoses, different public education and awareness of cancer symptoms, different degrees of access or availability of treatment., Conclusions: Our results highlight the future health care needs and requirements for AYA-specialised services to ensure a homogeneous treatment across different countries as well as the urgency for preventive initiatives that can mitigate the increasing burden., Competing Interests: Disclosure DS reports receipt of honoraria for providing academic peer review for research programme from French INCa, non-financial interest for advisory role in the clinical reference group advising NHS England about cancer policy in children and young people and non-remunerated membership of the Association of Cancer Physicians of the UK, SIOP Europe Adolescent Cancer Committee; IBS reports receipt of honoraria for participation in Advisory Board from Roche, receipt of honoraria as invited speaker from AstraZeneca, Novartis, Pfizer, Roche, receipt of personal and institutional financial interest as local PI from Novartis, Roche, non-financial interest for serving as local PI in EORTC Breast Group, OncoDistinct studies and non-remunerated advisory role in the Ethical Committee Serbia, National Agency for Drug Registration Serbia, the Working Group for Oncology of the Ministry of Health Serbia; NG reports receipt of honoraria to institution for participation in Advisory Board from Y-mAbs Therapeutics, receipt of financial support to institution from Eisai for covering travel expenses and registration fees as invited speaker at international meeting for the presentation of the results from the studies as international PI, receipt of consultancy fee to institution from Ipsen, non-remunerated Co-chair of the Fostering Age inclusive Research (FAIR) trial group of ACCELERATE; non-remunerated member of the Executive Committee of EEC (Euro-Wing Consortium), non-financial interest for leadership role as Chair of the FOSTER Consortium (Fight Osteosarcoma Through European Research) and non-remunerated member of GO-AJA, SFCE, SIOP Europe; FP reports receipt of honoraria for participation in Advisory Board from Roche Diagnostics, receipt of honoraria for providing expert testimony from Ipsen, Merck and non-financial interest for leadership role as Scientific Director of the European School of Oncology; ATo reports receipt of honoraria for participation in Advisory Board from MSD, AstraZeneca, Pfizer, Eli Lilly, receipt of honoraria as invited speaker from Eli Lilly, Novartis and non-remunerated member of AIOM; KS reports receipt of honoraria for participation in Advisory Board from Bayer, Novartis, Novo Nordisk, Roche, non-financial interest for leadership role in PanCare, SPOG, SSPHO and non-remunerated member of Board of Directors of SIOP Europe; GM reports receipt of honoraria for participation in Advisory Board from BMS, Janssen, Roche, Takeda, and receipt of honoraria as invited speaker from Amgen, AstraZeneca, MSD, Novartis, Pfizer; SB reports receipt of honoraria for participation in Advisory Board from Bayer Healthcare, Boehringer Ingelheim, Eli Lilly, Hofmann La Roche, MAP-Biopharma; non-financial interest as principal investigator of the Bayer’s larotrectinib study; and non-remunerated member of the European Musculoskeletal Oncology Society (EMSOS), German Pediatric Oncology Society (GPOH); ES reports receipt of honoraria for participation in Advisory Board from AstraZeneca A.E., AstraZeneca UK Ltd., Gilead Sciences Hellas, Merck, Sharp & Dohme, Pfizer Hellas, receipt of honoraria as invited speaker from Amgen Hellas, Pfizer Hellas, receipt of honoraria for providing expert testimony from Ipsen and non-remunerated member of Board of Directors of Hellenic Oncology Research Group, Hellenic Society of Medical Oncology. All other authors have declared no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The European Society for Medical Oncology (ESMO) Designated Centres (DCs) of Integrated Oncology and Palliative Care is an incentive programme established in 2003 aiming to improve the integration of oncology and palliative care services provided by oncologists and oncology centres worldwide. Currently, the ESMO DCs programme has over 250 centres accredited from 54 countries worldwide, in all six world regions., Materials and Methods: To evaluate how ESMO can support centres to improve programme development, education and research and vice versa what each single centre can do to improve in these areas, we developed a survey which was shared with all active centres. Two hundred and seven ESMO DCs representing 44 countries were invited to participate. We used content analysis to identify response categories using a stepwise approach. After reviewing and coding all responses to each question separately, they were placed into categories, counted and labelled., Results: Of the 207 centres that were invited to participate, 146 centres started the survey, representing 43 countries. Five overarching topics were identified. They included (i) joint events and educational activities; (ii) sharing of materials and defining common standards; (iii) sharing of experiences, scientific knowledge and expertise; (iv) research collaboration; and (v) ESMO support. Respondents were willing to support the ESMO DC community group in all topics and were also asking ESMO to support their centres in these issues in the future., Conclusion: The study showed that the ESMO DCs are willing to provide support to improve education, research and programme development. They are also eager to contribute and collaborate amongst each other, but also request ESMO to offer advice and help to improve these issues in the DCs. In the future, facilitation of joint research projects and development of arenas to share experiences, educational and programme developments, and other resources are to be explored and could be offered to the DCs worldwide., Competing Interests: Disclosure The authors have declared no conflicts of interest., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: ESMO COVID-19 and CAncer REgistry (ESMO-CoCARE) is an international collaborative registry-based, cohort study gathering real-world data from Europe, Asia/Oceania and Africa on the natural history, management and outcomes of patients with cancer infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)., Patients and Methods: ESMO-CoCARE captures information on patients with solid/haematological malignancies, diagnosed with coronavirus disease 2019 (COVID-19). Data collected since June 2020 include demographics, comorbidities, laboratory measurements, cancer characteristics, COVID-19 clinical features, management and outcome. Parameters influencing COVID-19 severity/recovery were investigated as well as factors associated with overall survival (OS) upon SARS-CoV-2 infection., Results: This analysis includes 1626 patients from 20 countries (87% from 24 European, 7% from 5 North African, 6% from 8 Asian/Oceanian centres), with COVID-19 diagnosis from January 2020 to May 2021. Median age was 64 years, with 52% of female, 57% of cancer stage III/IV and 65% receiving active cancer treatment. Nearly 64% patients required hospitalization due to COVID-19 diagnosis, with 11% receiving intensive care. In multivariable analysis, male sex, older age, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, body mass index (BMI) <25 kg/m 2 , presence of comorbidities, symptomatic disease, as well as haematological malignancies, active/progressive cancer, neutrophil-to-lymphocyte ratio (NLR) ≥6 and OnCovid Inflammatory Score ≤40 were associated with COVID-19 severity (i.e. severe/moderate disease requiring hospitalization). About 98% of patients with mild COVID-19 recovered, as opposed to 71% with severe/moderate disease. Advanced cancer stage was an additional adverse prognostic factor for recovery. At data cut-off, and with median follow-up of 3 months, the COVID-19-related death rate was 24.5% (297/1212), with 380 deaths recorded in total. Almost all factors associated with COVID-19 severity, except for BMI and NLR, were also predictive of inferior OS, along with smoking and non-Asian ethnicity., Conclusions: Selected patient and cancer characteristics related to sex, ethnicity, poor fitness, comorbidities, inflammation and active malignancy predict for severe/moderate disease and adverse outcomes from COVID-19 in patients with cancer., Competing Interests: Disclosure MS was financed by the Ministry of Science and Higher Education of the Russian Federation within the framework of state support for the creation and development of World-Class Research Centers ‘Digital biodesign and personalized healthcare’ number 075-15-2020-926. DV reports travel, accommodations and expenses from Merk; honoraria for speakers bureau from Servier. RL reports speaker fee Astra Zeneca and institutional funding from BMS. ACr reports consulting or advisory role with Ipsen, Astellas, Pfizer, MSD Oncology Research (funding to self and hospital), Bristol-Myers Squibb, Merck (only hospital), Astellas, Amgen, Exelixis, Merck KGaA; and travel accommodations from Merck and Servier. SŠ reports honoraria and/or advisory fees from Roche, Pfizer, Novartis, Astra Zeneca and Amicus. MR received travel and personal fees from Novartis and Ipsen. TAG reports honoraria and/or advisory fees from IPSEN, Pfizer, Bayer, Sanofi, Janssen, Astellas, Adacap, Eisai, Lilly, Novartis, BMS. TKC reports institutional and personal, paid and unpaid support for research, advisory boards, consultancy and honoraria from AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers-Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVA, Infinity, Ipsen, Jansen, Kanaph, Lilly, Merck, NiKang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events (PeerView, OncLive, MJH and others), outside the submitted work; institutional patents filed on molecular mutations and immunotherapy response and ctDNA; equity in Tempest, Pionyr, Osel, Nuscan; serves on committees for NCCN, GU Steering Committee and ASCO/ESMO; Medical writing and editorial assistance support may have been funded by communications companies in part; no speaker’s bureau; has mentored several non-United States citizens on research projects with potential funding (in part) from non-United States sources/Foreign components; the institution (Dana-Farber Cancer Institute) may have received additional independent funding of drug companies or/and royalties potentially involved in research around the subject matter. TKC is supported in part by the Dana-Farber/Harvard Cancer Center Kidney SPORE (2P50CA101942-16) and Program 5P30CA006516-56, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham and Loker Pinard Funds for Kidney Cancer Research at DFCI. s provided upon request for scope of clinical practice and research. DA reports consultation/advisory role for AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi (Genzyme), Bayer, Terumo, Roche, Hexal, Samsung Bioepis, Pierre Fabre Pharma, CRA International, Ketchum, IQVIA; reports speaker’s engagement from AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi (Genzyme), Bayer, Eli Lilly, Terumo, Boston Scientific, Amgen, Roche, Ipsen, Merck (Serono), Samsung Bioepis, Pierre Fabre Pharma, Servier, PharmaCept, PRMA Consulting, Tactics MD LLC, WebMD Health Corp, From Research to Practice, Aptitude Health, art tempi media, ACE Oncology, Imedex, streamitup Germany, MedAhead (Austria), Clinical Care Options (CCO); reports serving as local PI for Bristol Myers Squibb, Pierre Fabre Pharma and coordinating PI for OncoLytics; reports grant funding from AbbVie; reports being/been DSMB chair of Sanofi (Genzyme); reports being/been a steering committee member of Roche. KH declares research funding from AstraZeneca, Boehringer-Ingelheim, MSD, Replimune and advisory board fees/honoraria from Arch Oncology, AstraZeneca, BMS, Boehringer-Ingelheim, Codiak Biosciences, Inzen Therapeutics, Merck-Serono, MSD, Pfizer, Replimune. OM reports personal fees from Bristol-Myers Squibb, MSD, Novartis, Roche, Amgen, NeraCare GmbH, outside the submitted work. UD reports honorarium as Member of the Tumor Agnostic Evidence Generation Working Group of Roche, outside the submitted work. GP reports grants from Amgen, Lilly; grants, personal fees and nonfinancial support from Merck; grants and non-financial support from AstraZeneca; grants and personal fees from Roche, Bristol Myers Squibb, MSD, Novartis, outside the submitted work. SPe reports consultation/advisory role for AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Biocartis, Bio Invent, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, Elsevier, F. Hoffmann-La Roche/Genentech, Foundation Medicine, Illumina, Incyte, IQVIA, Janssen, Medscape, Merck Sharp and Dohme, Merck Serono, Merrimack, Mirati, Novartis, Pharma Mar, Phosplatin Therapeutics, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda, Vaccibody; talk in a company’s organized public event for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, e-cancer, Eli Lilly, F. Hoffmann-La Roche/Genentech, Illumina, Medscape, Merck Sharp and Dohme, Novartis, PER, Pfizer, Prime, RTP, Sanofi, Takeda; receipt of grants/research supports from being a (sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, F. Hoffmann-La Roche/Genentech, GSK, Illumina, Lilly, Merck Sharp and Dohme, Merck Serono, Mirati, Novartis, and Pfizer, Phosplatin Therapeutics. ER reports investigator-initiated trial (funds paid to the institution) supported by Astra-Zeneca, BMS; serves on the consultancy/advisory board for Astra-Zeneca, Merck, Roche, Pierre Fabre. All other authors have declared no conflicts of interest., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group., Methods: This consensus manuscript aims at discussing clinical evidence and providing expert advice on statements related to the management of HMs in the COVID-19 pandemic. For this purpose, an international consortium was established including a steering committee, which prepared six working packages addressing significant clinical questions from the COVID-19 diagnosis, treatment, and mitigation strategies to specific HMs management in the pandemic. During a virtual consensus meeting, including global experts and lead by the European Society for Medical Oncology and the European Hematology Association, statements were discussed and voted upon. When a consensus could not be reached, the panel revised statements to develop consensual clinical guidance., Results and Conclusion: The expert panel agreed on 33 statements, reflecting a consensus, which will guide clinical decision making for patients with hematological neoplasms during the COVID-19 pandemic., Competing Interests: DIsclosure CB reports honoraria from Roche/Genentech, Janssen, BeiGene, Novartis, Pfizer, Incyte, AbbVie, Gilead Sciences, Celltrion, MorphoSys, Regeneron; he reports consulting or advisory role: Gilead Sciences, Janssen, Roche, Pfizer, BeiGene, Celltrion, AbbVie, Incyte, Regeneron, MorphoSys, Novartis; he reports speaker’s engagement: Roche, Janssen, BeiGene, Celltrion, AbbVie, Pfizer, Gilead Sciences; he reports research funding: Roche/Genentech, Janssen, Celltrion, Merck Sharp & Dohme (MSD), Pfizer, Amgen. MD reports honoraria as Advisory Board Member of AstraZeneca, Bayer, BeiGene, Celgene, Genmab, Gilead, Incyte, Janssen, Lilly, MorphoSys, Novartis, Roche; he reports honoraria for speaker’s engagement from Amgen, AstraZeneca, Bayer, Celgene, Gilead, Janssen, Novartis, Roche; he reports institutional research grants from AbbVie, Bayer, Gilead, Celgene, Janssen, Roche. AA-L has declared no conflicts of interest. JA reports personal financial interests as advisory board and invited speaker from Incyte, advisory board from Mallinckrodt, advisory board and invited speaker from Novartis, advisory board and invited speaker from Pfizer; she reports non-financial interests as principal investigator from Incyte, principal investigator from Novartis. LA received advisory honoraria from Roche, Celgene, Janssen-Cilag, Verastem, Eusa Pharma, Incyte, ADC Therapeutics and Gilead; research support from Gilead, and travel expenses from Roche, Celgene, Janssen-Cilag, and Eusa Pharma; speakers bureau from Novartis. CB has declared no conflicts of interest. LB reports Advisory Committee activities for AbbVie, Amgen, Astellas, Bristol Myers Squibb (BMS), Celgene, Daiichi Sankyo, Gilead, Hexal, Janssen, Jazz Pharmaceuticals, Menarini, Novartis, Pfizer, Sanofi, Seattle Genetics and has research support from Bayer and Jazz Pharmaceuticals. PC has declared no conflicts of interest. MGDP has declared no conflicts of interest. MD reports personal fees from Amgen, personal fees from Takeda, personal fees from Janssen, personal fees from BeiGene, personal fees from BMS, outside the submitted work. SD reports personal financial interests as advisory board, invited speaker, fellow funding, and coordinating PI from BeiGene, writing engagement from Karger, advisory board and coordinating PI from Sanofi, funding, and other from Janssen; she reports non-financial interests as advisory role at British Society for Haematology Lymphoma Special Interest Group, advisory role at Lymphoma Action, member of board of directors at WMUK Charity. HTE has declared no conflicts of interest. RF reports honoraria for advisory boards and/or speaker bureau from Janssen, Gilead, AbbVie, Amgen, Novartis, Roche, Incyte, Pfizer, all outside the submitted work. PG reports grants and personal fees from AbbVie, grants and personal fees from Acerta/AstraZeneca, personal fees from BeiGene, personal fees from Celgene/Juno/BMS, grants and personal fees from Janssen, personal fees from Lilly/Loxo, personal fees from MEI, personal fees from Roche, personal fees from Sanofi, personal fees from ArQule/MSD, outside the submitted work; MGdS reports grants, personal fees, non-financial support and other from Gilead Sciences, grants from AstraZeneca, personal fees, non-financial support, and other from Janssen Cilag, personal fees and non-financial support from Roche, non-financial support from AbbVie, personal fees and non-financial support from BMS, personal fees and non-financial support from MSD, personal fees and non-financial support from Takeda, personal fees from Novartis, personal fees from ADC Therapeutics, outside the submitted work. JG reports personal fees from AbbVie, grants and personal fees from AstraZeneca, grants and personal fees from BMS/Celgene, grants and personal fees from Janssen, personal fees from Kite/Gilead, personal fees from MorphoSys, personal fees from Novartis, personal fees from TG Therapeutics, outside the submitted work. RH has had a consultant or advisory relationship with Janssen, Amgen, Celgene, AbbVie, BMS, Novartis, PharmaMar, and Takeda; has received honoraria from Janssen, Amgen, Celgene, BMS, PharmaMar, and Takeda; has received research funding from Janssen, Amgen, Celgene, BMS, Novartis, and Takeda. CH reports grants and personal fees from Novartis, grants and personal fees from BMS, personal fees from Sierra Oncology, personal fees from CTI pharmaceuticals, personal fees from Jannsen, personal fees from Geron, grants and personal fees from AOP Orphan Pharma, personal fees from Galecto, grants, personal fees and other from Constellation, outside the submitted work. MH reports personal fees from Novartis, personal fees from Pfizer, personal fees from Roche, personal fees from AbbVie, personal fees from Daiichi Sankyo, personal fees from Bayer Pharma AG, personal fees from Jazz Pharmaceuticals, personal fees from BMS, personal fees from Tolremo, outside the submitted work. BK has received honoraria for lectures from Ipsen, Novartis and MSD (all outside of the submitted work). J-JK reports consulting fees and honoraria from Novartis, consulting fees from AbbVie, honoraria from AOP Orphan Pharma, participation on a monitoring board or advisory board from BMS/Celgene, participation on a monitoring board or advisory board from Incyte. NK reports grants and honoraria from Neovii, honoraria from Sanofi, grants and honoraria from Jazz, grants and honoraria from Celgene, grants and honoraria from Riemser, honoraria from Gilead/Kite, honorarium from AOP Oprhan Pharma, grants and honorarium from Novartis, honorarium from Amgen. PM reports personal fees from Celgene, Amgen, Janssen, AbbVie, Sanofi, outside the submitted work. JP has declared no conflicts of interest. FP has declared no conflicts of interest. DR received honoraria from Incyte, Novartis Pharma, Pfizer; clinical trial steering committee membership: Novartis; membership on advisory boards: Incyte, Novartis Pharma, Pfizer. J-MR reports grants and honoraria from Novartis, Amgen, Pfizer, Takeda, Incyte, and Servier. TR has declared no conflicts of interest. JF-M reports consulting and advisory boards honoraria (received by CUN ) from AbbVie, Amgen, BMS, Celgene, Janssen, GlaxoSmithKline, Karyopharm, MSD, Novartis, Takeda, Sanofi, SecuraBio, Regeneron, Roche, outside the submitted work. VS has declared no conflicts of interest. GFS reports personal fees and other from AbbVie, other from Amgen, other from Astellas, other from Boehringer-Ingelheim, grants, personal fees and other from Celgene, other from Helsinn Healthcare, grants, personal fees, and other from Janssen-Cilag, grants and other from Novartis, other from Onconova, grants, personal fees and other from Roche, and other from Takeda, outside the submitted work. PS reports honoraria from Amgen, Celgene, Janssen, Karyopharm, SkylineDx, Takeda, and research support from Celgene, Janssen, Amgen, Takeda, BMS, SkylineDx, Karyopharm, all outside the submitted work. MvL-T has received travel grants and honoraria from Celgene, Gilead, Chugai, Janssen, Novartis, Amgen, Takeda, BMS, Medac, Oncopeptides, Merck, CDDF, Pfizer, Medac, Thermo Fisher, AstraZeneca; is a consultant for Celgene, Gilead, Oncopeptides, MSD, 4D Pharma, Janssen, Shionogi and received research funding from BMBF, Deutsche Jose Carreras Leukämie-Stiftung, IZKF Jena, Novartis, Gilead, Deutsche Krebshilfe, Celgene, Oncopeptides, Deutsche Forschungsgemeinschaft (DFG). CW has declared no conflicts of interest. GP reports grants from Amgen, grants, personal fees and non-financial support from Merck, grants and non-financial support from AstraZeneca, grants and personal fees from Roche, grants and personal fees from BMS, grants from Lilly, grants and personal fees from MSD, grants and personal fees from Novartis, outside the submitted work. FP reports grants from Novartis, Celgene, BMS, Abbvie, Karyopharma, Janssen., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: With the implementation of multidisciplinary treatment and development of multiple novel anticancer drugs in parallel with expanding knowledge of supportive and palliative care, a need for separate training and specialisation in medical oncology emerged. A Global Curriculum (GC) in medical oncology, developed and updated by a joint European Society for Medical Oncology/American Society of Clinical Oncology (ESMO/ASCO) GC Task Force/Working Group (GC WG), greatly contributed to the recognition of medical oncology worldwide., Material and Methods: ESMO/ASCO GC WG carried out a global survey on medical oncology recognition and GC adoption in 2019., Results: Based on our survey, medical oncology is recognised as a separate specialty or sub-specialty in 47/62 (75%) countries participating in the survey; with a great majority of them (39/47, 83%) recognising medical oncology as a standalone specialty. Additionally, in 9 of 62 (15%) countries, medical oncology is trained together with haematology as a specialty in haemato-oncology or together with radiotherapy as a specialty in clinical oncology. As many as two-thirds of the responding countries reported that the ESMO/ASCO GC has been either fully or partially adopted or adapted in their curriculum. It has been adopted in a vast majority of countries with established training in medical oncology (28/41; 68%) and adapted in 12 countries with mixed training in haemato-oncology, clinical oncology or other specialty responsible for training on systemic anticancer treatment., Conclusions: With 75% of participating countries reporting medical oncology as a separate specialty or sub-specialty and as high as 68% of them reporting on GC adoption, the results of our survey on global landscape are reassuring. Despite a lack of data for some regions, this survey represents the most comprehensive and up-to-date information about recognition of medical oncology and GC adoption worldwide and will allow both societies to further improve the dissemination of the GC and global recognition of medical oncology, thus contributing to better cancer care worldwide., Competing Interests: Disclosure TC reports receipt of honoraria for participation in Advisory Board of Boehringer Ingelheim, Takeda, receipt of honoraria as invited speaker from MSD, Pfizer, Roche, institutional financial support for research from Merck Sharp & Dohme (MSD); MK reports receipt of honoraria for consulting or advisory role from Biocept, participating in speakers' bureau of Astellas Pharma, Genentech, Roche, Sanofi, Lilly, Bayer, Medivation, Astellas, Novartis, Bristol-Myers Squibb (BMS), Janssen Oncology, Pfizer, MSD, institutional research funding from Genentech, Roche, Merck Serono, covered travel and accommodations expenses by Genentech, Bayer, Medivation, Astellas, Sanofi, Novartis, BMS, Janssen Oncology, Pfizer, MSD; PÖ reports receipt of grants and personal fees from Roche, Merck, Sanofi Oncology, Amgen, Bayer, Eli Lilly, Nordic Drugs, and personal fees from Baxalta/Shire; AA reports receipt of honoraria for participation in Advisory Board of Roche, Pfizer, Eli Lilly and Company, Eisai, Novartis, MSD and BMS; NE-S reports receipt of honoraria from Roche, Novartis, MSD Oncology, AstraZeneca, Lilly, Pfizer, research funding (to Institution) from GlaxoSmithKline, Roche, Novartis; FL reports receipt of honoraria for participation in Advisory Board from Amgen, Astellas, Bayer, Beigene, BMS, Eli Lilly, MSD, Roche, Zymeworks, receipt of honoraria as invited speaker from AstraZeneca, BMS, Eli Lilly, Imedex, Medscape, MedUpdate, MerckSerono, MSD, Promedicis, Roche, Servier, StreamedUp!, receipt of honoraria for expert testimony from Biontech, Elsevier, receipt of honoraria for writing engagement from Deutscher Ärzteverlag, Iomedico, Springer-Nature, receipt of institutional research grant from BMS; PR reports receipt of honoraria for participation in Advisory Board of Blueprint Medicines, BMS, Merck, MSD, Pierre Fabre, Sanofi, receipt of honoraria as invited speaker from BMS, Merck, MSD, Novartis, Pierre Fabre, Sanofi, institutional research grants from BMS, Pfizer; AT reports receipt of honoraria for participation in Advisory Board from Merck, receipt of honoraria as invited speaker from AstraZeneca, Eli Lilly, Merck, Pfizer; HW reports receipt of honoraria to institution for participation in Advisory Board of AstraZeneca, Biocartis, Daiichi Sankyo, Eisai, KCE, Lilly, Novartis, Orion Corporation, Pfizer, PSI Cro AG, Puma Biotechnology, Roche, Sirtex, institutional research grants from Novartis, Roche, covered travel and accommodations expenses by Pfizer, Roche. All other authors have declared no conflicts of interest., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: A skilled health workforce is instrumental for the delivery of multidisciplinary cancer care and in turn a critical component of the health systems. There is, however, a paucity of data on the vast inequalities in cancer workforce distribution, globally. The aim of this study is to describe the global distribution and density of the health care workforce involved in multidisciplinary cancer management., Methods: We carried out a systematic review of the literature to determine ratios of health workers in each occupation involved in cancer care per 100 000 population and per 100 cancer patients (PROSPERO: protocol CRD42018095414)., Results: We identified 33 eligible papers; a majority were cross-sectional surveys (n = 16). The analysis of the ratios of health providers per population and per patients revealed deep gaps across the income areas, with gradients of workforce density, highest in high-income countries versus low-income areas. Benchmark estimates of optimal workforce availability were provided in a secondary research analysis: mainly high-income countries reported workforce capacities closer to benchmark estimates. A paucity of literature was defined for critical health providers, including for pediatric oncology, surgical oncology, and cancer nurses., Conclusion: The availability and distribution of the cancer workforce is heterogeneous, and wide gaps are described worldwide. This is the first systematic review on this topic. These results can inform policy formulation and modelling for capacity building and scaleup., Competing Interests: Disclosure GC reports consultancy from Bristol Myers Squibb, Lilly, Novartis, Pfizer, Roche, Seagen, and Daiichi Sankyo; employment at the University of Milano, Istituto Europeo di Oncologia, IRCCS, Milano, Italy; and speaker's bureau participation for Lilly, Pfizer, Roche, Seagen, and Daiichi Sankyo. AI and MB are employees of WHO. The other authors have declared no conflicts of interest., (Copyright © 2021. Published by Elsevier Ltd.)

Inflammation is an established driver of severe SARS-CoV-2 infection and a mechanism linked to the increased susceptibility to fatal COVID-19 demonstrated by patients with cancer. As patients with cancer exhibit a higher level of inflammation compared with the general patient population, patients with cancer and COVID-19 may uniquely benefit from strategies targeted at overcoming the unrestrained pro-inflammatory response. Targeted and non-targeted anti-inflammatory therapies may prevent end-organ damage in SARS-CoV-2-infected patients with cancer and decrease mortality. Here, we review the clinical role of selective inhibition of pro-inflammatory interleukins, tyrosine kinase modulation, anti-tumor necrosis factor agents, and other non-targeted approaches including corticosteroids in their roles as disease-modulating agents in patients with COVID-19 and cancer. Investigation of these therapeutics in this highly vulnerable patient group is posited to facilitate the development of tailored therapeutics for this patient population, aiding the transition of systemic inflammation from a prognostic domain to a source of therapeutic targets., Competing Interests: Disclosure DJP has received lecture fees from ViiV Healthcare and Bayer Healthcare; travel expenses from Bristol-Myers Squibb (BMS) and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, and AstraZeneca; and received research funding (to institution) from Merck Sharp & Dohme (MSD) and BMS. AC has received lecture fees from AstraZeneca, MSD, Novartis, and Astellas and consulting fees/advisory board grants from AstraZeneca, MSD, Roche, and BMS. AG has declared consulting/advisory roles for Roche, MSD, Eli Lilly, Pierre Fabre, EISAI, and Daichii Sankyo; speakers bureau for Eisai, Novartis, Eli Lilly, Roche, Teva, Gentili, Pfizer, AstraZeneca, Celgene, and Daichii Sankyo; research funds from EISAI, Eli Lilly, and Roche. GP has received advisory board fees from Amgen, AstraZeneca, BMS, Lilly, Merck, MSD, Roche and research funding (to institution) from Amgen, Abbvie, Boehringer, AstraZeneca, BMS, Lilly, Merck, MSD, Roche, Debiopharm, Ipsen, Pfizer, Servier. ER received research funding from Amgen, AstraZeneca, and BMS; travel expenses from Astra Zeneca, BMS, Merck, and Roche. All other authors have declared no conflicts of interest., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

It is well recognised that adolescents and young adults (AYA) with cancer have inequitable access to oncology services that provide expert cancer care and consider their unique needs. Subsequently, survival gains in this patient population have improved only modestly compared with older adults and children with cancer. In 2015, the European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOPE) established the joint Cancer in AYA Working Group in order to increase awareness among adult and paediatric oncology communities, enhance knowledge on specific issues in AYA and ultimately improve the standard of care for AYA with cancer across Europe. This manuscript reflects the position of this working group regarding current AYA cancer care, the challenges to be addressed and possible solutions. Key challenges include the lack of specific biological understanding of AYA cancers, the lack of access to specialised centres with age-appropriate multidisciplinary care and the lack of available clinical trials with novel therapeutics. Key recommendations include diversifying interprofessional cooperation in AYA care and specific measures to improve trial accrual, including centralising care where that is the best means to achieve trial accrual. This defines a common vision that can lead to improved outcomes for AYA with cancer in Europe., Competing Interests: Funding The European Society for Medical Oncology (ESMO) (no grant number) and the European Society for Paediatric Oncology (SIOPE) (no grant number) were the legal sponsors of this position paper. No research funding for the meetings or manuscript preparation was received from any third parties. Disclosure DS reports receipt of research grants from Teenage Cancer Trust. FAP reports personal financial interest as a Scientific Director at the European School of Oncology; receipt of lecture/presentation fees from Prime Oncology and Takeda; receipt of honoraria for advisory board participation/advisory services from Roche, AstraZeneca, Clovis and Ipsen. LF reports receipt of funding from Teenage Cancer Trust. IB-S reports receipt of speaker fees from Roche, Novartis and Pfizer; direct research funding as Principal Investigator from Roche; financial support to institution for clinical trials from Roche. OS reports receipt of honoraria for advisory board participation from Genuity Science. LH reports receipt of speaker fees from Roche. WTAvdG reports receipt of research funding from Novartis, honoraria for advisory board from Bayer and consultancy fees from SpringWorks, all to her institutes. SB reports receipt of honoraria for advisory board participation from Pfizer, Bayer, Lilly, Novartis and Isofol. GM reports receipt of speakers fees from AstraZeneca, Roche, MSD, BMS, Pfizer, Takeda, Janssen, Novartis and Sanofi; receipt of consultancy fees from AstraZeneca, Roche, MSD, BMS, Novartis and Sanofi; direct research funding as Principal Investigator from AstraZeneca, Novartis and MSD; financial support to institution for clinical trials from AstraZeneca, Novartis and MSD. ES reports receipt of honoraria for the provision of advisory services from Roche Hellas, BMS, Pfizer Hellas, AstraZeneca, Amgen Hellas and Dimiourgiki Farmakeutikon Ypiresion AE; receipt of research funding from Astellas Pharma; travel and education support from Roche Hellas, Pfizer Hellas, Astellas Pharma, Novartis (Hellas), MSD Greece and Enorasis. All other authors have declared no conflicts of interest., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Click here to listen to the Podcast BACKGROUND: Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) serves to grade therapies with curative intent. Hitherto only few trials with curative intent have been field tested using form 1. We aimed to evaluate the applicability of the scale and to assess the reasonableness of the generated scores in early colon cancer, in order to identify shortcomings that may be rectified in future amendments., Methods: Adjuvant studies were identified in PubMed, Food and Drug Administration and European Medicines Agency registration sites, as well as ESMO and National Comprehensive Cancer Network guidelines. Studies meeting inclusion criteria were graded using form 1 of the ESMO-MCBS V.1.1 and field tested by ESMO Colorectal Cancer Faculty. Shortcomings of the scale were identified and evaluated., Results: Eighteen of 57 trials and 7 out of 14 meta-analyses identified met criteria for ESMO-MCBS V.1.1 grading. In stage III colon cancer, randomised clinical trials and meta-analyses of modulated 5-fluorouracil (5-FU) based chemotherapy versus surgery scored ESMO-MCBS grade A and randomised controlled trials (RCTs) and meta-analyses comprising oxaliplatin added to this 5-FU backbone showed a more modest additional overall survival benefit (grade A and B). For stage II colon cancer, the findings are less consistent. The fluoropyrimidine trials in stage II were graded 'no evaluable benefit' but the most recent meta-analysis demonstrated a 5.4% survival advantage after 8 years follow-up (grade A). RCTs and a meta-analysis adding oxaliplatin demonstrated no added benefit. Exploratory toxicity evaluation and annotation was problematic given inconsistent toxicity reporting and limited results of late toxicity. Field testers (n=37) reviewed the scores, 25 confirmed their reasonableness, 12 found them mostly reasonable. Moreover, they identified the inability of crediting improved convenience in non-inferiority trials as a shortcoming., Conclusion: Form 1 of the ESMO-MCBS V.1.1 provided very reasonable grading for adjuvant colon cancer studies., Competing Interests: Competing interests: EGEdV reports Institutional Financial Support for her advisory role from Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi, Synthon and Institutional Financial Support for clinical trials or contracted research from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Synthon, all outside the submitted work., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

Click here to listen to the Podcast BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated value scale for solid tumour anticancer treatments. Form 1 of the ESMO-MCBS, used to grade therapies with curative intent including adjuvant therapies, has only been evaluated for a limited number of studies. This is the first large-scale field testing in early breast cancer to assess the applicability of the scale to this data set and the reasonableness of derived scores and to identify any shortcomings to be addressed in future modifications of the scale., Method: Representative key studies and meta-analyses of the major modalities of adjuvant systemic therapy of breast cancer were identified for each of the major clinical scenarios (HER2-positive, HER2-negative, endocrine-responsive) and were graded with form 1 of the ESMO-MCBS. These generated scores were reviewed by a panel of experts for reasonableness. Shortcomings and issues related to the application of the scale and interpretation of results were identified and critically evaluated., Results: Sixty-five studies were eligible for evaluation: 59 individual studies and 6 meta-analyses. These studies incorporated 101 therapeutic comparisons, 61 of which were scorable. Review of the generated scores indicated that, with few exceptions, they generally reflected contemporary standards of practice. Six shortcomings were identified related to grading based on disease-free survival (DFS), lack of information regarding acute and long-term toxicity and an inability to grade single-arm de-escalation scales., Conclusions: Form 1 of the ESMO-MCBS is a robust tool for the evaluation of the magnitude of benefit studies in early breast cancer. The scale can be further improved by addressing issues related to grading based on DFS, annotating grades with information regarding acute and long-term toxicity and developing an approach to grade single-arm de-escalation studies., Competing Interests: Competing interests: SP-S reports institutional financial support for her advisory role from Astra Zeneca, Pfizer, Novartis, Roche, Teva, NanoString; EGEdV reports institutional financial support for her advisory role from Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi, Synthon and institutional financial support for clinical trials or contracted research from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Synthon; MJP reports scientific board member for Oncolytics, consultant honoraria from AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Genentech, Huya, Immunomedics, Lilly, Menarini, MSD, Novartis, Odonate, Periphagen, Pfizer, Roche, Seattle Genetics, research grants to institute AstraZeneca, Lilly, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, Synthon; FC reports institutional financial support for her advisory role from Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline (GSK), Merck-Sharp, Merus BV, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Teva., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

During the last years, there has been a dramatic increase in the administrative and bureaucratic burden associated with clinical research, which has clearly had an impact on its overall efficiency and on the activity of clinical investigators and research teams. Indeed, the supervision of the adherence of clinical research to Good Clinical Practice (GCP) guidelines and legal regulations is of the utmost importance. Yet, while such regulations have remained largely unchanged during recent years, the number of administrative tasks and their complexity have grown markedly, as supported by the results of a survey performed among 940 clinical investigators that we report in this manuscript. Therefore, many investigators believe that it has become necessary to undertake a rigorous analysis of the causes and consequences of this issue, and to create a conduit to channel the advice from experienced investigators regarding clinical research procedures, in order to improve them. Based on these premises, ESMO has launched the ESMO Clinical Research Observatory (ECRO), a task force that will analyse different aspects of clinical research. ECRO will aim to provide the views of ESMO on clinical research procedures based on the feedback from clinical investigators, under complete adherence to the Declaration of Helsinki, the GCP guidelines and any other applicable legal regulations, while at the same time showing profound respect for all the stakeholders involved in clinical research. This manuscript provides the background and rationale for the creation of ECRO, its planned activity and an analysis of the current administrative burden in clinical research with recommendations to rationalise it. Indeed, we expect that this effort shall lead to a relevant improvement in the care of patients and in the development of clinical research., Competing Interests: Competing interests: JLP-G: Research grants and support: Roche, BMS, MSD, Ipsen, Eisai, Incyte, Janssen. Speakers bureau and advisory boards: Roche, BMS, Ipsen, Eisai, MSD, Seattle Genetics. Travel support: Roche, MSD, BMS. AA: Advisory role, research grants to my Institute. Speaker fees: Roche, Lilly, Amgen, EISAI, BMS, Pfizer, Novartis, MSD, Genomic Health, Ipsen, AstraZeneca, Bayer, Leo Pharma. EC: Honoraria or consultation fees: Astellas, Novartis, Nanobiotix, Pfizer, Janssen-Cilag, GLG, PsiOxus Therapeutics, Merck, Medscape, BMS, Gilead, Seattle Genetics, Pierre Fabre, Boehringer Ingelheim, Cerulean Pharma, EUSA, Gehrmann Consulting, AstraZeneca, Roche, Guidepoint, Servier, Celgene, Abbvie, Amcure, OncoDNA, Alkermes. Leadership role: Director, Clinical Research, START Madrid, Director, Clinical Research, HM Hospitals Group, Madrid. Stocks or ownership: START, Oncoart Associated, International Cancer Consultants. Licensing fees or royalties: None. Direct research funding as project lead: Novartis, AstraZeneca, Beigene. Institutional financial support from clinical trials: Abbvie, ACEO, Amcure, AMGEN, AstraZeneca, BMS, Cytomx, GSK, Genentech/Roche, H3, Incyte, Janssen, Kura. Lilly, Loxo, Nektar, Macrogenics, Menarini, Merck, Merus, Nanobiotix, Novartis, Pfizer, PharmaMar, Principia, PUMA, Sanofi, Taiho, Tesaro, BeiGene, Transgene, Takeda, Incyte, Innovio, MSD, PsiOxus, Seattle Genetics, Mersana, GSK, Daiichi, Nektar, Astellas, ORCA, Boston Therapeutics, Dynavax, DebioPharm, Boehringen Ingelheim, Regeneron, Millenium, Synthon, Spectrum, Rigontec. Non-financial interests: Scientific board at PsiOxus. Leadership in medical society: Founder and president, non-for-profit Foundation INTHEOS (Investigational Therapeutics in Oncological Sciences). Memberships: SEOM, EORTC, ESMO, ASCO. Other relationships: HM Hospitals Group and START, Program of Early Phase Clinical Drug Development in Oncology, Employee: Medical Oncologist, Director, Clinical Research. Methods in Clinical Cancer Research (MCCR) Workshop, Zeist, Netherlands (Joint ECCO-AACR-EORTC-ESMO Workshop on Methods in Clinical Cancer, Research), Co-director. TA: travel grants from Novartis, personal fees and travel grants from BMS, personal fees from Pierre Fabre and research grant from Neracare, outside the submitted work. H-TA: Research Support to Employer: Employee of HCA Healthcare UK and Sarah Cannon Research Institute. Advisory Boards: Roche, Servier, Merck Serono, Biontech, Bicycle, Taiho, Beigene, Iovance, Bayer, Guardant. VG: honoraria for lectures and advisory role: AstraZeneca, Bayer, BMS, EUSAPharm, Ipsen, Pfizer, MSD, Lilly, PharmaMar. Novartis, Nanobiotix, MerckSerono, Janssen-Cliag, Exelexis, Roche, Eisai, Cerulean. Research funding: AstraZeneca, BMS, Novartis, MSD, Pfizer. GB: Advisory board and speakers bureau: Pfizer, Novartis Roche Servier Janssen Ipsen Lilly Amgen Merck. Travel support: Pfizer Janssen Roche MSD. MPL: Research grants (to hospital) MSD/Astellas/JnJ/ Sanofi. Advice: Roche/ Bayer/Amgen/JnJ/ Sanofi/ Servier/Pfizer/ Incyte. MDN: Speakers bureau and advisory boards: BMS. Travel support: MSD, BMS. NP: Research grants and support: Bayer HealthCare, Roche, Sanofi. Speakers bureau and advisory boards: Astellas, Bayer HealtCare, Ipsen, Janssen Roche, Genetics. Travel support: Ipsen, Pharmamar. MFS: Research grants: Roche. RV: Speakers bureau and advisory boards: Roche, BMS, MERK, AMGEN, SANOFI, MSD, BAYER, SERVIER. Travel support: Roche, MSD, AMGEN, MERK, SANOFI, BAYER. J-YD: No conflict of interest to disclose., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

COVID-19 pandemic challenges health system capacities in many countries. National healthcare services have to manage unexpected shortage of healthcare resources that have to be reallocated according to the principles of fair and ethical prioritisation, in order to maintain the highest levels of care to all patients, ensure the safety of patients and healthcare workers and save as many lives as possible. Beyond that, cancer care services have to pursue restructuring, following the same evidence-based dispositions. In this article, we propose guidance to the management of colorectal cancer during the pandemic, prioritised according to a three-tiered framework, based on expert clinical judgement and magnitude of benefit expected from specific interventions. Since the availability of resources for diagnostic procedures, surgery and postoperative care, systemic therapy and radiotherapy may differ, authors did separate prioritisation analyses. The impact of postponing or abrogating cancer interventions on outcomes according to a high, medium or low priority scale, is outlined and discussed. The implementation of healthcare services using telemedicine is explored: it reveals itself as functional and effective for limiting patients' need to travel to centres and thereby has the potential to reduce diffusion of severe acute respiratory syndrome coronavirus 2. Colorectal cancer demands a considerable amount of medical resources. Therefore, the redefinition of its diagnostic and therapeutic algorithms with a rigorous method is crucial in order to ensure the highest quality of continuum of care in the broader context of the pandemic and the challenged healthcare systems., Competing Interests: Competing interests: LV is a member of the GI connect group, spouse is employee and shareholder of Bayer AG. LV reported grants for translational research from Pierre Fabre und is participant in the Charité-BIH Clinician Scientist Program funded by the Charité Universitaetsmedizin Berlin und Berlin Institute of Health. SS: personal fees from Amgen, Bayer, Isofol, Lilly, Merck KGaA, MSD, Nordic Pharma, Pierre-Fabre, Roche, Sanofi, Sirtex, Servier, Takeda, Taiho, research grants from Pierre-Fabre, Merck KGaA, Roche. GP: Research grants from Amgen, AstraZeneca, Roche, MSD, BMS, Merck, outside of the submitted work. FL: personal fees from Amgen, Astellas, AstraZeneca, Biontech, Eli Lilly, Elsevier, Excerpta Medica, Imedex, Infomedica, Medscape, MedUpdate, Merck Serono, Merck Sharp & Dohme, Oncovis, Promedicis, Springer Nature, StreamedUp!, and Zymeworks; and research grants and personal fees from Bristol-Myers Squibb and Iomedico, outside the submitted work., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

The COVID-19 pandemic is challenging the capacities of health systems in many countries. National healthcare services have to manage unexpected shortages of healthcare resources that have to be re-allocated according to the principles of fair and ethical prioritisation, in order to maintain the highest levels of care to all patients, ensure the safety of patients and healthcare workers, and save as many lives as possible. Also, cancer care services have to pursue restructuring, following the same evidence-based dispositions. In this article, we propose a guidance to the management of pancreatic cancer during the pandemic, prioritised according to a three-tiered framework, and based on expert clinical judgement and magnitude of benefit expected from specific interventions. Since the availability of resources for diagnostic procedures, surgery and postoperative care, systemic therapy and radiotherapy may differ, the authors have separated the prioritisation analyses. The impact of postponing or abrogating cancer interventions on outcomes according to a high, medium or low priority scale is outlined and discussed. The implementation of healthcare services using telemedicine is explored; it reveals itself as functional and effective for limiting patients' need to travel to centres and thereby has the potential to reduce diffusion of SARS-CoV-2. Pancreatic cancer demands a considerable amount of medical resources. Therefore, the redefinition of its diagnostic and therapeutic algorithms with a rigorous method is crucial in order to ensure the highest quality of continuum of care in the broader context of the pandemic and the challenged healthcare systems., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

Background: The academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors' concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer., Methodology: CAREFOR (Clinical Academic Cancer Research Forum), a multi-stakeholder platform formed to improve the direction for academic clinical trials in the field of oncology in Europe, formed the CAREFOR-Industry Working Group comprised of experienced professionals from European academic cooperative groups joined by industry representatives selected based on their activities in the area of medical oncology. They jointly discussed academic cooperative groups, clinical trials conducted between academic cooperative groups and industry, examples of successful collaborative models, common legal negotiation points in clinical trial contracts, data access, and principles of interaction., Results: Four principles of interaction between the academia and industry are proposed: (1) clarify the roles and responsibilities of all partners involved in the study, (2) involve legal teams from an early stage; (3) acknowledge that data is an important output of the study, (4) agree on the intent of the trial prior to its start., Conclusions: The CAREFOR-Industry Working Group describes current models, challenges, and effective strategies for academia-industry research in Europe with an eye towards improving academia-industry partnerships on clinical trials for patients with cancer. Current perceived challenges are explained, and future opportunities/recommendations for improvement are described for the areas of most significant impact. Challenges are addressed from both the academic and industry perspectives, and principles of interaction for the optimal alignment between academia and industry in selected areas are proposed., Competing Interests: Competing interests: RAS reports: In the past two years, I have received honoraria as a consultant at advisory boards from Abbvie, Astra Zeneca, MSD, Pfizer, Regeneron, Roche and Takeda. In the past two years, I have received honoraria as a speaker from Astra Zeneca, Boehringer Ingelheim, Eli Lilly, MSD and Roche. DMC in the last two years: Genentech/Roche and Takeda Financial Support of ETOP trials (president and scientific chair): AstraZeneca, BMS, Boehringer Ingelheim, Genentech, MSD, Roche and Pfizer; FC reports personal fees from Amgen, personal fees from Astellas/Medivation, personal fees from AstraZeneca, personal fees from Celgene, personal fees from Daiichi-Sankyo, personal fees from Eisai, personal fees from GE Oncology, personal fees from Genentech, personal fees from GlaxoSmithKline, personal fees from Macrogenics, personal fees from Medscape, personal fees from Merck-Sharp, personal fees from Merus BV, personal fees from Mylan, personal fees from Mundipharma, personal fees from Novartis, personal fees from Pfizer, personal fees from Pierre-Fabre, personal fees from prIME Oncology, personal fees from Roche, personal fees from Sanofi, personal fees from Seattle Genetics, personal fees from Teva, outside the submitted work; PGC reports personal fees from Bayer, personal fees from Deciphera, personal fees from Eisai, personal fees from Eli Lilly, personal fees from Nektar Ther, personal fees from Pfizer, grants from Advenchen Lab, grants from Amgen Dompé, grants from AROG, grants from Bayer, grants from Bluerint, grants from Daiichi Sankyo, grants from Deciphera, grants from Eisai, grants from Eli Lilly, grants from Epizyme, grants from Glaxo, grants from Karyopharm, grants from Novartis, grants from Pfizer, grants from PharmaMar, outside the submitted work; RM reports personal fees from Pfizer, outside the submitted work; AH reports grants and non-financial support from Abbott Molecular Inc, grants from Amgen (Europe) GmbH, grants and non-financial support from Amgen Inc, grants and non-financial support from Amgen Ltd, grants and non-financial support from AstraZeneca AG Switzerland, grants and non-financial support from AstraZeneca UK Ltd, grants from AstraZeneca Wilmington, grants and non-financial support from Biodesix Inc, grants and non-financial support from Boehringer Ingelheim RCV GmbH & Co. KG, grants from Boehringer Ingelheim (Schweiz) GmbH, grants from Bristol-Myers Squibb Company, grants and non-financial support from Bristol-Myers Squibb International Corporation, grants and non-financial support from Eli Lilly Export SA, grants from Eli Lilly Regional Operations GmbH, grants and non-financial support from F. Hoffmann-La Roche Ltd, grants and non-financial support from Genentech Inc, grants from Merck KGaA, grants and non-financial support from MSD MERCK SHARP & DOHME AG, grants from Pfizer Inc, grants from Pfizer Pharma GmbH, grants from Takeda, outside the submitted work., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

Objective: Value frameworks in oncology have not been validated for the assessment of treatments in haematological malignancies, but to avoid overlaps and duplications it appears reasonable to build up experience on existing value frameworks, such as the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS)., Methods: Here we present the results of the first feasibility testing of the ESMO-MCBS v1.1 for haematological malignancies based on the grading of 80 contemporary studies for acute leukaemia, chronic leukaemia, lymphoma, myeloma and myelodysplastic syndromes. The aims were (1) to evaluate the scorability of data, (2) to evaluate the reasonableness of the generated grades for clinical benefit using the current version and (3) to identify shortcomings in the ESMO-MCBS v1.1 that require amendments to improve the efficacy and validity of the scale in grading new treatments in the management of haematological malignancies., Results: In general, the ESMO-MCBS v1.1 was found to be widely applicable to studies in haematological malignancies, generating scores that were judged as reasonable by European Hematology Association (EHA) experts. A small number of studies could either not be graded or were not appropriately graded. The reasons, related to the differences between haematological and solid tumour malignancies, are identified and described., Conclusions: Based on the findings of this study, ESMO and EHA are committed to develop a version of the ESMO-MCBS that is validated for haematological malignancies. This development process will incorporate all of the usual stringencies for accountability of reasonableness that have characterised the development of the ESMO-MCBS including field testing, statistical modelling, evaluation for reasonableness and openness to appeal and revision. Applying such a scale will support future public policy decision-making regarding the value of new treatments for haematological malignancies and will provide insights that could be helpful in the design of future clinical trials., Competing Interests: Competing interests: BK has received honoraria for lectures from Celgene and Novartis; NB has received honoraria for consulting and advisory role from Ariad, Amgen, Novartis and Pfizer; EGEdV declares advisory role for Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi and Synthon, and institutional financial support for clinical trials or contracted research for Amgen, AstraZeneca, Bayer, Chugai, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Roche and Synthon; PG has received honoraria for lectures/advisory boards and research funding from AbbVie/Pharmacyclics, Acerta/AstraZeneca, BeiGene, Janssen, Gilead, Novartis, Sunesis and Verastem; NG has received honoraria for lectures, advisory boards and research support from Amgen, Pfizer and Incyte; VG-C has received honoraria for lectures from Janssen and for participation in advisory boards from Prothena; BH has received honoraria for lectures from Novartis, Pfizer and BMS, and for participation in advisory boards from Novartis, GlaxoSmithKline, Abbvie, Pfizer, BMS and Incyte; UJ has declared honoraria from Abbvie, BMS, Celgene, Amgen, Roche, Novartis, Gilead, Bioverativ, Janssen, MSD, Sandoz, Takeda and Pfizer; M-VM has received honoraria for lectures from Janssen, Celgene, Takeda and Amgen, and for participation in advisory boards from Janssen, Celgene, Takeda, Amgen, AbbVie, GlaxoSmithKline and PharmaMar; MR has received honoraria for lectures from Novarits, Ipsen, Celgene and Eisai; LS has received honoraria for lectures from Janssen, AbbVie, AstraZeneca, and for participation in advisory boards from Janssen; PS has received honoraria for lectures and advisory boards from Celgene, Janssen, Takeda and Amgen, and research support from Celgene, Janssen and Amgen., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

This review article is an overview of the session at the European Society for Medical Oncology (ESMO) Asia 2018 Congress entitled: 'Cancer medicines in Asia and Asia-Pacific: What is available, and is it effective enough?'. The article provides an overview of the session speakers' views on the impact that the lack of accessibility and availability of medicines has on patient outcomes in the treatment of breast cancer, colorectal cancer and lung cancer, responsible for more than one-third of cancer deaths in the Asian region. It also lists the various global policy initiatives that ESMO supports to promote the best cancer care in the Asian and Asia-Pacific region. The review presents extrapolated data from the 'ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe', which reveals several disparities among Asian countries, across the different income levels. In low- and middle-income countries, some barriers to the accessibility of anticancer medicines include the lack of government reimbursement, budget allocation for healthcare and quality-assured generic and biosimilar medicines, as well as shortages and patent rights. Throughout the article, the session presenters provide their views on strategies that can be considered to overcome these barriers., Competing Interests: Competing interests: AE has received research support from AstraZeneca, Pfizer, Celltrion, Novartis, none in relation to this publication.

Gastrointestinal (GI) cancers are common in all parts of the world. Effective prevention and early detection of GI cancers are not universally implemented. Therefore, it must be anticipated that the incidence and the mortality of GI cancers will remain high within the next decades. The European Society for Medical Oncology (ESMO) Gastrointestinal Cancer Faculty aims to increase the skills of medical oncologists and other disciplines involved in treating GI malignancies. We aimed to increase the survival chances for patients with GI cancers, augment their quality of life and enable successful return to normal social and professional life during the period of survivorship. ESMO also aims to decrease the economic burden of GI cancer in our societies and national healthcare systems. Therefore, the ESMO Gastrointestinal Cancer Faculty initiated a consensus process based on the Delphi method to identify the most important educational needs of physicians who are concerned with GI malignancies. This paper summarises the process and its results and outlines the mission of ESMO in education., Competing Interests: Competing interests: FL reports receiving grants, personal fees and non-financial support from BMS; and personal fees from Astellas, Astra Zeneca, Biontech, Eli Lilly, Elsevier, Infomedica, Merck, MSD, Roche, Servier and Amgen outside the submitted work. EVC reports participation in advisory boards for Astrazeneca, Bayer, Bristol-Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche and Servier, and receiving research grants from Amgen, Bayer, Boehringer Ingelheim, Celgene, Ipsen, Lilly, Roche, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche and Servier paid to the institution outside the submitted work. JT reports personal fees and others from Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics outside the submitted work. FC reports receiving personal fees from Roche/Genentech, Merck Serono, Pfizer, Amgen, Servier, Lilly, Bayer, Bristol-Myers Squibb and Celgene; and grants from Bayer, Amgen, and Merck Serono outside the submitted work. AC reports having a consultant or advisory role at Merck Serono, Roche, Beigene, Bayer, Servier, Lilly, Novartis, Takeda, Astelas and Pierre Fabre; receiving research funding from Genentech, Merck Serono, Roche, Beigene, Bayer, Servier, Lilly, Novartis, Takeda, Astelas, Fibrogen, Amcure, Sierra Oncology, Astra Zeneca, Medimmune, BMS, MSD and Pierre Fabre; receiving speaker honoraria from Merck Serono, Roche, Angem, Bayer, Servier and Foundation Medicine; and receiving grant support from Merck Serono and Roche. RO, DV, JYD and KMG have no conflict of interest to declare.

Background: Adolescents and young adults (AYAs) with cancer require dedicated management encompassing both adult and paediatric cancer services. Following a European survey, the European Society for Medical Oncology, the European Society for Paediatric Oncology and the Asian continental branch of International Society of Paediatric Oncology undertook a similar survey to assess AYA cancer care across Asia., Methods: A link to the online survey was sent to healthcare professionals (HCPs) in Asia interested in AYA cancer care. Questions covered the demographics and training of HCPs, their understanding of AYA definition, availability and access to specialised AYA services, the support and advice offered during and after treatment, and factors of treatment non-compliance., Results: We received 268 responses from 22 Asian countries. There was a striking variation in the definition of AYA (median lower age 15 years, median higher age 29 years). The majority of the respondents (78%) did not have access to specialised cancer services and 73% were not aware of any research initiatives for AYA. Over two-thirds (69%) had the option to refer their patients for psychological and/or nutritional support and most advised their patients on a healthy lifestyle. Even so, 46% did not ask about smokeless tobacco habits and only half referred smokers to a smoking cessation service. Furthermore, 29% did not promote human papillomavirus vaccination for girls and 17% did not promote hepatitis B virus vaccination for high-risk individuals. In terms of funding, 69% reported governmental insurance coverage, although 65% reported that patients self-paid, at least partially. Almost half (47%) reported treatment non-compliance or abandonment as an issue, attributed to financial and family problems (72%), loss of follow-up (74%) and seeking of alternative treatments (77%)., Conclusions: Lack of access to and suboptimal delivery of AYA-specialised cancer care services across Asia pose major challenges and require specific interventions., Competing Interests: Competing interests: CKL: Fees for Advisory Board from Amgen Asia. SB: Fees for Advisory Boards from Pfizer, Bayer, Lilly, Novartis, Isofol. LB: Fees for Advisory Board from Takeda. FAP: Fees from Roche, Astra Zeneca, Clovis and Ipsen. DS: Research support from the National Institute for Health Research, Cancer Research UK, the Teenage Cancer Trust, Pharmamar and AstraZeneca.

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology's Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency., Competing Interests: Competing interests: JdM reports grants from Medicines for Europe - European Specialist Nurses Organisations (ESNO), outside the submitted work. EGEdV reports other from Sanofi, other from Pfizer, other from Daiichi Sankyo, grants from Amgen, grants from Genentech, grants from Roche, grants from Chugai Pharma, grants from Synthon, grants from CytomX Therapeutics, grants from Nordic Nanovector, grants from Regeneron, grants from G1 Therapeutics, grants from AstraZeneca and grants from Radius Health, outside the submitted work. JT reports other from Bayer, Boehringer Ingelheim, Genentech/Roche, Lilly, MSD, Merck Serono, Merrimack, Novartis, Peptomyc, Roche, Sanofi, Symphogen and Taiho, outside the submitted work. LA reports research grants and honoraria from AbbVie, Merck-MSD, Pfizer, Celltrion, Takeda, Janssen, Mundipharma, Shire, Celgene, Otsuka, Atlantic Healthcare, TiGenix, Ferring Pharmaceutical and Vifor Pharma.

Background: A recent international consensus panel identified 13 major indicators to assess the level of integration between oncology and palliative care. We examined these indicators among European Society for Medical Oncology (ESMO) Designated Centres (ESMO-DCs) of Integrated Oncology and Palliative Care (PC) and determined the centre characteristics associated with greater integration., Methods: This is a preplanned secondary analysis of a recent survey to characterise the structure, processes and outcomes of the palliative care programmes at ESMO-DCs. We assessed the level of integration using 13 major indicators. We calculated two Palliative Care and Oncology Integration Indexes consisting of all 13 indicators (PCOI-13, range 0-13) and 9 of the 13 indicators (PCOI-9, range 0-9), with a higher index indicating greater integration., Results: The survey response rate was 152/184 (83%). Among the 13 major indicators, interdisciplinary team was most likely to be achieved (95%), while early referral to palliative care (median time from referral to death >6 months before death) was only present in 24 (20%) of ESMO-DCs. The median PCOI-13 was 7.8 (IQR 6.4-9.6) and the median PCOI-9 was 6 (IQR 5-7). The presence of dually trained palliative oncologists was associated with higher PCOI-13 (median 8.4 vs 7.0; p=0.01) and PCOI-9 (median 6 vs 5; p=0.03). Non-tertiary hospitals generally had higher PCOI-13 (median 8.6 vs 7.2; p=0.01) and ESMO-DCs outside of Europe had higher PCOI-9 (median 7 vs 6; p=0.03)., Conclusions: Assessment of the level of integration at ESMO-DCs with PCOIs highlighted strengths, areas for further development and how double-boarded palliative oncologists may promote integration., Competing Interests: Competing interests: None declared.

The cancer burden is rising globally, exerting significant strain on populations and health systems at all income levels. In May 2017, world governments made a commitment to further invest in cancer control as a public health priority, passing the World Health Assembly Resolution 70.12 on cancer prevention and control within an integrated approach. In this manuscript, the 2016 European Society for Medical Oncology Leadership Generation Programme participants propose a strategic framework that is in line with the 2017 WHO Cancer Resolution and consistent with the principle of universal health coverage, which ensures access to optimal cancer care for all people because health is a basic human right. The time for action is now to reduce barriers and provide the highest possible quality cancer care to everyone regardless of circumstance, precondition or geographic location. The national actions and the policy recommendations in this paper set forth the vision of its authors for the future of global cancer control at the national level, where the WHO Cancer Resolution must be implemented if we are to reduce the cancer burden, avoid unnecessary suffering and save as many lives as possible., Competing Interests: Competing interests: AE: Currently conducting research sponsored by AstraZeneca, Pfizer, Celltrion, Novartis, Roche. JT: Advisory Boards for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Genentech, Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho, and Takeda. FCi: Advisory Boards: Merck Serono, Amgen, Roche, Bayer, Lilly, Servier. Research funding: Bayer, Roche, Merck Serono. GP: Honorarium for advisory boards or speakers fee: Roche, Celgene, Shire, Merck, Amgen, Lilly, BMS, Servier, Taiho, Halozyme, Sanofi. PC: Honoraria for consultancy/advisory role and/or for lectures from: Bayer, Blueprint Medicines, Deciphera Pharmaceuticals, Eisai, Eli Lilly, Nektar Ther., Novartis, Pfizer, PharmaMar. At his institution, his Unit received funds for research from: AmgenDompé, Arog Pharmaceuticals, Bayer, Eisai, Eli Lilly, Daiichi Sankyo Pharma, Epizyme Inc., Novartis, PharmaMar. MS: Conducts research sponsored by Janssen Pharmaceuticals. Advisory Boards: BMS, Novartis, Janssen Pharmaceuticals, Leo Pharma. Speaker bureau for BMA, Novartis. Travel funding: Novartis, BMS, Astellas, Ipsen. All other authors declare no competing interests related to this paper.

Background: The European Society for Medical Oncology (ESMO) has developed the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), a tool to assess the magnitude of clinical benefit from new cancer therapies. Grading is guided by a dual rule comparing the relative benefit (RB) and the absolute benefit (AB) achieved by the therapy to prespecified threshold values. The ESMO-MCBS v1.0 dual rule evaluates the RB of an experimental treatment based on the lower limit of the 95%CI (LL95%CI) for the hazard ratio (HR) along with an AB threshold. This dual rule addresses two goals: inclusiveness: not unfairly penalising experimental treatments from trials designed with adequate power targeting clinically meaningful relative benefit; and discernment: penalising trials designed to detect a small inconsequential benefit., Methods: Based on 50 000 simulations of plausible trial scenarios, the sensitivity and specificity of the LL95%CI rule and the ESMO-MCBS dual rule, the robustness of their characteristics for reasonable power and range of targeted and true HRs, are examined. The per cent acceptance of maximal preliminary grade is compared with other dual rules based on point estimate (PE) thresholds for RB., Results: For particularly small or particularly large studies, the observed benefit needs to be relatively big for the ESMO-MCBS dual rule to be satisfied and the maximal grade awarded. Compared with approaches that evaluate RB using the PE thresholds, simulations demonstrate that the MCBS approach better exhibits the desired behaviour achieving the goals of both inclusiveness and discernment., Conclusions: RB assessment using the LL95%CI for HR rather than a PE threshold has two advantages: it diminishes the probability of excluding big benefit positive studies from achieving due credit and, when combined with the AB assessment, it increases the probability of downgrading a trial with a statistically significant but clinically insignificant observed benefit., Competing Interests: Competing interests: The authors have declared the following: JB: director of EORTC. EORTC conducts many studies sponsored by, or otherwise supported by, a large number of companies. EORTC is an independent research organisation. MJP: board member: Radius. Consultant (honoraria): AstraZeneca, Lilly, MSD, Novartis, Pfizer, Roche-Genentech, Crescendo Biologics, Periphagen, Huya, Debiopharm and PharmaMar. Research grants to institute: AstraZeneca, Lilly, MDS, Novartis, Pfizer, Roche-Genentech, Synthon, Radius and Servier. Speakers bureau/stock ownership: none. GP: consulting and advisory services, and research support: Amgen, Merck, AstraZeneca, Roche, BMS, MSD and Lilly. J-YD: compensated participation to advisory boards, lecture and symposia: Amgen, Merck Serono, Bayer, Roche/Genentech, Sanofi, AstraZeneca, Boehringer-Ingelheim and Sirtex until April 2016. No further compensated participation in industry events from May 2016 onwards. JT: advisory boards for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Genentech, Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho and Takeda. CCZ: honoraria: AstraZeneca, Celgene, Roche, Novartis, Bristol Myers Squibb, MSD, Ariad and Newgen. EGEdV: currently conducting research sponsored by the following companies: Amgen, Roche/Genentech, Chugai Pharma, Synthon, AstraZeneca, Radius Health, CytomX Therapeutics and Nordic Nanovector (all payments to the institution). Consulting or advisory role for the following companies: Synthon, Medication and Merck (all payments to the institution). Not a member of any speakers' bureau.

Introduction: Adolescents and young adults (AYA) with cancer require dedicated clinical management and care. Little is known about the training and practice of European healthcare providers in regard to AYA and the availability of specialised services., Methods: A link to an online survey was sent to members of the European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOPE). The link was also sent to ESMO National Representatives and circulated to other European oncology groups. Questions covered the demographics and clinical training of respondents, their definition of AYA, education about AYA cancer, access to specialised clinical and supportive care, research and further education. Data from Europe were analysed by region., Results: Three hundred tweenty two questionnaires were submitted and we focused on data from the 266 European healthcare professionals. Responses revealed considerable variation both within and between countries in the definition of AYA. Over two-thirds of respondents did not have access to specialised centres for AYA (67%), were not aware of research initiatives focusing on AYA with cancer (69%) and had no access to specialist services for managing the late effects of treatment (67%). The majority of the respondents were able to refer AYA patients to professional psychological support and specialised social workers. However, more than half had no access to an age-specialised nurse or specialised AYA education. Overall, 38% of respondents reported that their AYA patients did not have access to fertility specialists. This figure was 76% in Eastern Europe. Lack of specialised AYA care was particularly evident in Eastern and South-Eastern Europe., Conclusion: There is important underprovision and inequity of AYA cancer care across Europe. Improving education and research focused on AYA cancer care should be a priority., Competing Interests: Competing interests: DS: Research support from the National Institute for Health Research, Cancer Research UK, the Teenage Cancer Trust, Pharmamar and Astra-Zeneca. SB: Fees for Advisory Boards from Pfizer, Bayer, Lilly, Novartis, Isofol. FAP: Fees from Roche, Astra Zeneca, Clovis and Ipsen. ES, LB, SJ, KM, J-YD, GM, SE: No relevant disclosures to declare.

Cancer is a complex disease that is constantly evolving. It is now the most common cause of death in Europe after cardiovascular diseases. There are inequalities among European countries, potentially unsustainable healthcare systems impacting quality of cancer care and increasing number of patients with cancer with rare conditions. Clinical and translational research are the backbone in establishing scientific advances as novel treatments and advancing progress to the benefit of patients. Commercially sponsored clinical trials are responsible for developing new medicines that can treat various disease areas, including cancer. It is important to note, however, that these clinical trials only assess the viability of compounds that are chosen by a commercial entity that funds the entire process. By their design and focus, these trials need to fulfil commercial interests and market expectations, which do not always coincide with patients' needs. As soon or even before novel treatments and compounds obtain formal market authorisation, academia will take these existing and new medicines to further conduct research in order to optimise their use, develop new combinations and with a strong focus on the patients and their needs. Established standard of care most commonly relies on clinical cancer research stemming from non-commercial entities, cooperative groups or academic clinical research. This article provides a consensus on the definition of academic research, illustrates its added value and suggests and calls to European Union institutions to support this type of research for the benefit of patients., Competing Interests: Competing interests: None declared.

Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world., Competing Interests: Competing interests: JT serves on advisory boards for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho and Takeda. DA has, in the last 2 years, participated in advisory boards and/or acted as a speaker at meetings and/or recipient of travel support for participation in medical meetings for/from Roche, Merck Serono, Amgen, Bayer Healthcare, Sanofi-Aventis, Terumo and Sirtex. AC has acted as a consultant or advisor to Amgen, AstraZeneca, Sanofi-Aventis, Merck Serono, MSD, Genentech and Roche.

In this implementation phase of the European Cancer Patient's Bill of Rights (BoR), we confirm the following three patient-centred principles that underpin this initiative:The right of every European citizen to receive the most accurate information and to be proactively involved in his/her care.The right of every European citizen to optimal and timely access to a diagnosis and to appropriate specialised care, underpinned by research and innovation.The right of every European citizen to receive care in health systems that ensure the best possible cancer prevention, the earliest possible diagnosis of their cancer, improved outcomes, patient rehabilitation, best quality of life and affordable health care. The key aspects of working towards implementing the BoR are:Agree our high-level goal. The vision of 70% long-term survival for patients with cancer in 2035, promoting cancer prevention and cancer control and the associated progress in ensuring good patient experience and quality of life.Establish the major mechanisms to underpin its delivery. (1) The systematic and rigorous sharing of best practice between and across European cancer healthcare systems and (2) the active promotion of Research and Innovation focused on improving outcomes; (3) Improving access to new and established cancer care by sharing best practice in the development, approval, procurement and reimbursement of cancer diagnostic tests and treatments.Work with other organisations to bring into being a Europe based centre that will (1) systematically identify, evaluate and validate and disseminate best practice in cancer management for the different countries and regions and (2) promote Research and Innovation and its translation to maximise its impact to improve outcomes., Competing Interests: Competing interests: None declared.

The European Society for Medical Oncology (ESMO) is one of the leading societies of oncology professionals in the world. Approximately 30% of the 13 000 ESMO members are below the age of 40 and thus meet the society's definition of young oncologists (YOs). ESMO has identified the training and development of YOs as a priority and has therefore established a comprehensive career development programme. This includes a leadership development programme to help identify and develop the future leaders in oncology. Well-trained and highly motivated future generations of multidisciplinary oncologists are essential to ensure the optimal evolution of the field of oncology with the ultimate goal of providing the best possible care to patients with cancer. ESMO's career development portfolio is managed and continuously optimised by several dedicated committees composed of ESMO officers and is directly supervised by the ESMO Executive Board and the ESMO President. It offers unique resources for YOs at all stages of training and includes a broad variety of fellowship opportunities, educational courses, scientific meetings, publications and resources. In this article, we provide an overview of the activities and career development opportunities provided by ESMO to the next generation of oncologists., Competing Interests: Competing interests: None declared.

The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a standardised, generic, validated tool to stratify the magnitude of clinical benefit that can be anticipated from anticancer therapies. The ESMO-MCBS is intended to both assist oncologists in explaining the likely benefits of a particular treatment to their patients as well as to aid public health decision makers' prioritise therapies for reimbursement. From its inception the ESMO-MCBS Working Group has invited questions and critiques to promote understanding and to address misunderstandings regarding the nuanced use of the scale, and to identify shortcomings in the scale to be addressed in future planned revisions and updates. The ESMO-MCBS V.1.0 has attracted many questions regarding its development, structure and potential applications. These questions, together with responses from the ESMO-MCBS Working Group, have been edited and collated, and are herein presented as a supplementary resource., Competing Interests: Conflicts of Interest: None declared.

The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) thanks to contribution of 64 ESMO-appointed and 32 ASCO-appointed authors. First published in 2004 and updated in 2010, the GC edition 2016 answers to the need for updated recommendations for the training of physicians in medical oncology by defining the standard to be fulfilled to qualify as medical oncologists. At times of internationalisation of healthcare and increased mobility of patients and physicians, the GC aims to provide state-of-the-art cancer care to all patients wherever they live. Recent progress in the field of cancer research has indeed resulted in diagnostic and therapeutic innovations such as targeted therapies as a standard therapeutic approach or personalised cancer medicine apart from the revival of immunotherapy, requiring specialised training for medical oncology trainees. Thus, several new chapters on technical contents such as molecular pathology, translational research or molecular imaging and on conceptual attitudes towards human principles like genetic counselling or survivorship have been integrated in the GC. The GC edition 2016 consists of 12 sections with 17 subsections, 44 chapters and 35 subchapters, respectively. Besides renewal in its contents, the GC underwent a principal formal change taking into consideration modern didactic principles. It is presented in a template-based format that subcategorises the detailed outcome requirements into learning objectives, awareness, knowledge and skills. Consecutive steps will be those of harmonising and implementing teaching and assessment strategies., Competing Interests: JBe received research support to Karolinska Institutet and University Hospital from Amgen, AstraZeneca, Bayer, Merck, Roche and Sanofi-Aventis. JBu received travel accommodations from Genentech/Roche. FC received a consultant honoraria in Astellas/Medivation, AstraZeneca, Celgene, Daiitchi-Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline (GSK), Merck-Scharp, Merus BV, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Teva. HC has worked in a consulting or advisory role in Amgen received speakers’ bureau in Baxalta, Celgene and received research funding from Celgene. PC received honoraria for consultancy/advisory role and/or for lectures from Bayer, Blueprint Medicines, Eisai, Eli Lilly, Glaxo SK, Merck SD, Merck Serono, Nektar Ther., Novartis, Pfizer, PharmaMar. AC received honoraria from MerckSerono, Roche, Amgen, Bayer, Lilly and speakers’ bureau from Roche and MerckSerono. RC received research funding from Genentech/Roche, Puma Biotechnology, Novartis and travel, accommodations, expenses from Novartis. LDP received fees as consultant or for lectures (no speakers’ bureau) from F. Hoffmann-La Roche, Pfizer, Bristol Meyer Squibb, AstraZeneca, Qiagen, Boehringer Ingelheim. All fees were paid to Institution. MDS received honoraria and consultation fees from Amgen, Astellas, Bayer, Celgene, Dendreon, Eisai Inc, ESSA, Ferring, GSK, Janssen Cilag, Merck, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, Shionogi, Synthon, Takeda, Teva/OncoGenex; received research grant from Pierre Fabre Oncologie. EGEdV received research grants to the institute from Roche/Genentech, Amgen, Novartis, Pieris, Servier, is part of data monitoring committee in Biomarin and of advisory board in Synthon. CD received (un)restricted research grants donated to the research institute from Amgen, AstraZeneca, Bayer, Celgene, Eisai, Boehringer Ingelheim, Merck, MSD, Mundipharma, Novartis, Pfizer Corporation, PharmaMar, Pierre Fabre, Roche Austria, Sanofi-aventis, Takeda; received honoraria for consulting from AstraZeneca, Eli Lilly, Merck, Novartis Pharma, Roche Austria. DSD has worked in a consulting or advisory role for UpToDate and received research funding from Aeterna Zentaris (to Institution). LRD received research funding from GlaxoSmithKline (to Institution), Millennium (to Institution), Bristol-Myers Squibb (to Institution), Aeterna Zentaris (to Institution), Millenuim (to Institution) and has other relationship with Genentech. NES received honoraria from Roche, Novartis, MSD Oncology; received research funding from GlaxoSmithKline, Roche; received travel, accommodations, expenses from Novartis, Roche, Celgene. AE conduct research sponsored by Roche, GSK, Novartis, AstraZeneca, Celltrion, Apotex Inc. ME has stock and other ownership interests with Bristol-Myers Squibb, GE Healthcare, Nestle SA, Pfizer, CVS CAREMARK; has worked in a consulting or advisory role from Merck, Bristol-Myers Squibb, ALKERMES; received research funding from Altor BioScience, Bristol-Myers Squibb, Merck, Alkermes, Polynoma; received travel, accommodations, expenses from Myriad Genetics, Bristol-Myers Squibb, Merck. EF has worked as a consultant for Boehringer Ingelheim, Eli Lilly, Pfizer, Roche, BMS, MSD, Novartis; received speaker's bureau from Eli Lilly, BMS, Novartis. MFF has owned stock from Novartis. PKG research funding from Abbvie (to Institution) and Onyx (to Institution). AG has worked in a consulting or advisory role for Genentech/Roche (to Institution), Bayer (to Institution), Sanofi (to Institution), Bristol-Myers Squibb (to Institution), Lilly (to Institution), Boston Biomedical (to Institution), Amgen (to Institution); received research funding from Genentech/Roche (to Institution), Bayer (to Institution), Pfizer (to Institution), Eisai (to Institution), Sanofi (to Institution), Lilly (to Institution), Boston Biomedical (to Institution); received travel, accommodations, expenses from Genentech/Roche, Bayer, Bristol-Myers Squibb, Boston Biomedical, Amgen. SMH has stock and other ownership interests with Liquid Biotech, USA; has patents, royalties, other intellectual property with Liquid Biotech, USA. JH received advisory board and speaker fee from Tesaro and honorarium from SOBI. DVJ has worked in a consulting or advisory role for Bayer. UK received honoraria from Amgen, BMS, GSK, Glycotope, MerckSerono, Merck/MSD, Pfizer; received research support from Pfizer, MerckSerono, Innate, Sirtec. RK conduct research supported by Roche; a member of speaker's bureau of Roche, Meda, Novartis. SK received research funding from Novartis (to Institution), Merck (to Institution), Threshold Pharmaceuticals (to Institution), Gilead Sciences (to Institution), Bayer/Onyx (to Institution); received travel, accommodation, expenses from Novartis. C-HK received honoraria from Merck/Darmstadt, Amgen. MK is on speakers’ bureau for Astellas Pharma, Genentech/Roche, Sanofi, Lilly, Bayer; received research funding from Genentech/Roche (to Institution) and Merck Serono (to Institution). H-JL has received honoraria from Merck Serono, Roche, Celgene, Bayer, Boehringer Ingelheim; has served in a consulting or advisory role for Merck Serono, Roche, Bayer; received travel, accommodations, expenses from Merck Serono, Bayer, Roche. LL has served as a consultant/advisory for EISAI, BMS, MSD, Merck-Serono, Boehringer Ingelheim, DEBIOPHARM, SOBI, Novartis, AstraZeneca, Bayer and Roche; received research funds to institute for clinical studies from EISAI, MSD, Merck-Serono, Boehringer Ingelheim, Novartis, AstraZeneca and Roche; received travel coverage for medical meetings from Merck-Serono, DEBIOPHARM, SOBI, Bayer. PJL received research funding from Novartis (to Institution), Celgene (to Institution), ImClone Systems (to Institution), Taiho Pharmaceutical (to Institution); has patents, royalties, other intellectual property US PPA/61/499,988 Gene Expression Analysis of Thymic Neoplasms Inventors Sunil Badve, Yesim Gokmen-Polar, Patrick Loehrer (to Institution). RIL has served in consulting or advisory role for Roche, Novartis, Janssen; received speakers’ bureau from Roche, Novartis, Janssen. MJM received research funding from Astex Pharmaceuticals (to Institution). TN has ownership interest with Bioclassifier LLC; has role for invention of PAM50 breast cancer assay, which has been licensed to NanoString technologies and being marketed as Prosigna; has served as a consultant for NanoString. KÖ received speaker bureau from Novartis, Ipsen. PÖ received consulting fees, honoraria, travel grants or lecturing fees from Amgen, Bayer, Baxalta, Celgene, EliLilly, Merck, Nordic Drugs, Prime Oncology, Sanofi Oncology. AP received honoraria and consultancy fee from Amgen, Novartis, Bristol-Myers Squibb, Genmab A/S, Celgene, Janssen-Cilag, Millennium Pharmaceuticals, Onyx Pharmaceuticals, Sanofi Aventis. MR received honoraria from AstraZeneca; has served in a consulting or advisory role for Bayer, Pfizer, McKesson; received research funding from AstraZeneca (to Institution), AbbVie (to Institution), Myriad Genetics (to Institution), Biomarin (to Institution); received travel, accommodations, expenses from AstraZeneca, Biomarin. LS has served in a consulting or advisory role for bioTheranostics. MS conduct research sponsored by AstraZeneca, Bayer, Eisai, Exelixis, Genzyme. H-JS is an advisor for Roche, Bayer. LS has served in leadership for Eviti; has served in a consulting or advisory role for Merck; has patents, royalties, other intellectual property; as Co-Editor-in-Chief of UpToDate, Oncology. JS is an employee of Genentech; received honoraria, speakers’ bureau, travel, accommodations, expenses from Genentech. CNS received honoraria or research grant from Novartis, GSK, Pfizer, Merck, Lilly, BMS, Astellas, Bayer, Janssen, Sanofi. FS received unrestricted industry grants for clinical research from Celgene, Fresenius, Helsinn; FS participates in Novartis-lead clinical trials and received punctual advisorship (boards, expert meetings) from Acacia, ACRAF, Amgen, Baxter, Celgene, Danone, Fresenius, GlaxoSmithKline, Grünenthal, Helsinn, ISIS Global, Millennium/Takeda, Mundipharma, Novartis, Novelpharm, Nycomed, Obexia, Otsuka, Ono, Pharm-Olam, Pfizer, Psioxus, PrIME, Santhera, Sunstone, Teva, Vifor. RS received honoraria or consulting fee (paid to institution) from Roche, Merck KGaA/EMD-Serono, MSD/Merck & Co, Pfizer, Ipsen Pharma, Novartis. JT has worked in a consultant/advisory role for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho and Takeda. EV has stock and other ownership interests with McKesson; has worked in a consulting or advisory role for Abbvie, AstraZeneca, Boehringer Ingelheim, Celgene, Clovis Oncology, GeneCentric, Genentech, Merck, Synta, VentiRx, Eisai, Lilly, Transgene; received speakers’ bureau for Amgen; received research funding from Abbvie (to Institution), Bristol-Myers Squibb (to Institution), Gen Vec Inc, (to Institution), Sanofi (to Institution), Monsanto (to Institution), Cyclacel (to Institution); received travel, accommodations, expenses from Amgen. JSW has stock and other ownership interests with Altor BioScience, Celldex, cCam Biotherapeutics; received honoraria from Bristol-Myers Squibb, Merck, Genentech, Abbvie, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, Eisai, Altor BioScience, Lion Biotechnologies, Amgen, Roche, Ichor Medical Systems, Celldex, cCam Biotherapeutics, Pieris; has worked in a consulting or advisory role for Celldex, Ichor Medical Systems, cCam Biotherapeutics, Lion Biotechnologies, Pieris, Altor BioScience, Bristol-Myers Squibb, Merck, Genentech, Roche, Amgen, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo, Abbvie, Eisai; received research funding from Bristol-Myers Squibb (to Institution), Merck (to Institution), GlaxoSmithKline (to Institution), Genentech (to Institution), Astellas Pharma (to Institution), Incyte (to Institution), Roche (to Institution), Novartis (to Institution); received travel, accommodations, expenses from Bristol-Myers Squibb, GlaxoSmithKline, Daiichi Sankyo, Pieris, cCam Biotherapeutics, Lion Biotechnologies, Roche, Celldex, Amgen, Merck, AstraZeneca, Genentech.