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Discrimination; Gender equity; Oncology Discriminació; Equitat de gènere; Oncologia Discriminación; Equidad de género; Oncología Background Following a European Society for Medical Oncology Women for Oncology (ESMO W4O) survey in 2016 showing severe under-representation of female oncologists in leadership roles, ESMO launched a series of initiatives to address obstacles to gender equity. A follow-up survey in October 2021 investigated progress achieved. Materials and methods The W4O questionnaire 2021 expanded on the 2016 survey, with additional questions on the impact of ethnicity, sexual orientation and religion on career development. Results were analysed according to respondent gender and age. Results The survey sample was larger than in 2016 (n = 1473 versus 482), especially among men. Significantly fewer respondents had managerial or leadership roles than in 2016 (31.8% versus 51.7%). Lack of leadership development for women and unconscious bias were considered more important in 2021 than in 2016. In 2021, more people reported harassment in the workplace than in 2016 (50.3% versus 41.0%). In 2021, ethnicity, sexual orientation and religion were considered to have little or no impact on professional career opportunities, salary setting or related potential pay gap. However, gender had a significant or major impact on career development (25.5% of respondents), especially in respondents ≤40 years of age and women. As in 2016, highest ranked initiatives to foster workplace equity were promotion of work–life balance, development and leadership training and flexible working. Significantly more 2021 respondents (mainly women) supported the need for culture and gender equity education at work than in 2016. Conclusions Gender remains a major barrier to career progression in oncology and, although some obstacles may have been reduced since 2016, we are a long way from closing the gender gap. Increased reporting of discrimination and inappropriate behaviour in the workplace is a major, priority concern. The W4O 2021 survey findings provide new evidence and highlight the areas for future ESMO interventions to support equity and diversity in oncology career development. This work was supported by the European Society for Medical Oncology (no grant number).

Oncology; Transcriptomics; Tumor biopsies Oncologia; Transcriptòmica; Biòpsies tumorals Oncología; Transcriptómica; Biopsias tumorales Background: The current model of clinical drug development in oncology displays major limitations due to a high attrition rate in patient enrollment in early phase trials and a high failure rate of drugs in phase III studies. Objective: Integrating transcriptomics for selection of patients has the potential to achieve enhanced speed and efficacy of precision oncology trials for any targeted therapies or immunotherapies. Methods: Relative gene expression level in the metastasis and normal organ-matched tissues from the WINTHER database was used to estimate in silico the potential clinical benefit of specific treatments in a variety of metastatic solid tumors. Results: As example, high mRNA expression in tumor tissue compared to analogous normal tissue of c-MET and its ligand HGF correlated in silico with shorter overall survival (OS; p

Cancer; Caregivers; Patient education Cáncer; Cuidadores; Educación del paciente Càncer; Cuidadors; Educació del pacient Journal articles provide reliable and current information about cancer research. This can offer hope to people with cancer and help them make decisions about their care. Here, the authors suggest ways in which different groups may help people with cancer to find, view, and understand articles. For example, journals should make articles free to view if they describe research that could change patient care. Also, clear titles and easy-to-follow summaries or videos may help people to find relevant articles and understand the main findings. It is important to explore ways to best share research with all those whose lives it may affect.

Malalties neoplàstiques hematològiques; Perfil genètic; Precisió Enfermedades neoplásticas hematológicas; Perfil genético; Precisión Hematological neoplastic diseases; Genetic profile; Accuracy La patologia hematooncològica s’ha dividit en tres grups: limfoide, mieloide i leucèmia aguda limfoblàstica. S’ha definit la llista de gens adequada per a cada patologia i tots ells han estat seleccionats atenent a: La seva utilitat diagnòstica i de diagnòstic diferencial amb altres entitats i que, per tant, permetin a l’equip diagnòstic (hematòlegs, patòlegs o biòlegs) realitzar un diagnòstic ben fet. La seva utilitat pronòstica i predictiva, sempre que això comporti un canvi d’actitud terapèutica. Per exemple, indicació de trasplantament de progenitors o altres teràpies cel·lulars, canvi en el seguiment i canvi en el tipus de tractament. La seva utilitat terapèutica per a la indicació de l’ús de fàrmacs diana.

Perfil genètic; Tumors sòlids; Adults; Precisió Perfil genético; Tumores sólidos; Adultos; Precisión Genetic profile; Solid tumors; Adults; Accuracy En aquest estudi s’ha definit la llista de gens per a cada patologia i tots ells han estat seleccionats atenent a; la seva utilitat diagnòstica per definir els subtipus tumorals en localitzacions tumorals molt concretes; la seva utilitat pronòstica i predictiva, sempre que això comporti un canvi d’actitud terapèutica; la seva utilitat terapèutica per a la indicació de l’ús de fàrmacs diana.

Càncer en l’adult i pediatria; Síndromes hereditàries; Perfil genètic; Precisió Cáncer en el adulto y pediatría; Síndromes hereditarios; Perfil genético; Precisión Cancer in adults and pediatrics; Hereditary syndromes; Genetic profile; Accuracy En aquest estudi per a cadascuna de les síndromes es defineixen els criteris clínics d’estudi genètic que es basen en la probabilitat d’identificar variants patogèniques i en l’accionabilitat clínica. En alguns casos quan l’estudi es realitza per a una indicació terapèutica el criteri quedarà condicionat a l’aprovació d’aquesta indicació. En les síndromes en les quals els criteris són els de diagnòstic clínic (per exemple, síndromes endocrines) no s’especifiquen. Per a cada indicació clínica s’especifiquen els gens que s’han d’incloure i que s’han de fer constar en l’informe. En totes les indicacions s’inclou en l’assessorament genètic pretest oferir el cribratge oportunista dels gens BRCA1, BRCA2, MLH1, MSH2, MSH6. Per aquest motiu, aquests gens estan inclosos en tots els panels i no només en les síndromes relacionades.

Cancer; Cancer genetics Cáncer; Genética del cáncer Càncer; Genètica del càncer There is a growing need for systems that efficiently support the work of medical teams at the precision-oncology point of care. Here, we present the implementation of the Molecular Tumor Board Portal (MTBP), an academic clinical decision support system developed under the umbrella of Cancer Core Europe that creates a unified legal, scientific and technological platform to share and harness next-generation sequencing data. Automating the interpretation and reporting of sequencing results decrease the need for time-consuming manual procedures that are prone to errors. The adoption of an expert-agreed process to systematically link tumor molecular profiles with clinical actions promotes consistent decision-making and structured data capture across the connected centers. The use of information-rich patient reports with interactive content facilitates collaborative discussion of complex cases during virtual molecular tumor board meetings. Overall, streamlined digital systems like the MTBP are crucial to better address the challenges brought by precision oncology and accelerate the use of emerging biomarkers. Open access funding provided by Karolinska Institute

Background There is a lack of knowledge about the career paths and employment situation of young medical oncologists. The aim of our study was to evaluate the current professional standing of these professionals in Spain. Methods The Spanish Society of Medical Oncology + MIR section conducted a national online survey in May 2021 of young medical oncology consultants ( Results A total of 162 responses were eligible for analysis and included participants from 16 autonomous communities; 64% were women, 80% were consultants, and 20% were residents. More than half of the participants performed routine healthcare activity and only 7% research activity. Almost three quarters (73%) were subspecialized in a main area of interest and almost half of these chose this area because it was the only option available after residency. Half of the respondents (51%) considered working abroad and 81% believed the professional standing in Spain was worse than in other countries. After finishing their residency, only 22 were offered a job at their training hospital. Just 16% of participants had a permanent employment contract and 87% were concerned (score of ≥ 5 on a scale of 1–10) about their job stability. In addition, one quarter of the participants in our study showed an interest in increasing their research activity. Conclusions The choice of subspecialty in medical oncology may depend on job opportunities after residency rather than personal interest. The abundance of temporary contracts may have influenced the job stability concerns observed. Future mentoring strategies should engage in building a long-term career path for young medical oncologists.

Highlights • Risk of distress/burnout amongst oncology professionals continues to worsen since COVID-19 despite improved job performance. • Female and younger (≤40 years old) colleagues continue to be at higher risk of poor well-being and feeling burnout. • Job demands have increased, with nearly half now feeling overwhelmed with workload. • Concerns regarding career development/training, job security, and international fellowship opportunities remain high. • A quarter of oncology professionals reported considering changing their career, including leaving the oncology profession. Background COVID-19 has had a significant impact on the well-being and job performance of oncology professionals globally. The European Society for Medical Oncology (ESMO) Resilience Task Force collaboration set out to investigate and monitor well-being since COVID-19 in relation to work, lifestyle and support factors in oncology professionals 1 year on since the start of the pandemic. Methods An online, anonymous survey was conducted in February/March 2021 (Survey III). Key outcome variables included risk of poor well-being or distress (expanded Well-Being Index), feeling burnout (single item from expanded Well-Being Index), and job performance since COVID-19. Longitudinal analysis of responses to the series of three surveys since COVID-19 was carried out, and responses to job demands and resources questions were interrogated. SPSS V.26.0/V.27.0 and GraphPad Prism V9.0 were used for statistical analyses. Results Responses from 1269 participants from 104 countries were analysed in Survey III: 55% (n = 699/1269) female, 54% (n = 686/1269) >40 years, and 69% (n = 852/1230) of white ethnicity. There continues to be an increased risk of poor well-being or distress (n = 464/1169, 40%) and feeling burnout (n = 660/1169, 57%) compared with Survey I (25% and 38% respectively, P < 0.0001), despite improved job performance. Compared with the initial period of the pandemic, more participants report feeling overwhelmed with workload (45% versus 29%, P < 0.0001). There remain concerns about the negative impact of the pandemic on career development/training (43%), job security (37%). and international fellowship opportunities (76%). Alarmingly, 25% (n = 266/1086) are considering changing their future career with 38% (n = 100/266) contemplating leaving the profession. Conclusion Oncology professionals continue to face increased job demands. There is now significant concern regarding potential attrition in the oncology workforce. National and international stakeholders must act immediately and work closely with oncology professionals to draw up future-proof recovery plans.

The COVID-19 pandemic affected millions of people globally with lasting effects on society, patients, investigators and health institutions. Clinical trials, our best tool to improve cancer treatment for patients through testing the clinical value of a new treatment, have been affected by the pandemic. The pandemic footprint represents both a risk of compromising development of new therapies and an opportunity to elicit discussion over a portfolio of broader reforms, applicable irrespective of pandemics, in order to improve the design and implementation of clinical trials in oncology. The administrative load should be reduced, without affecting the quality of research and principles of good clinical practice. Cancer centres are encouraged to adapt their research/operational structures to the requirements of molecular oncology and embrace novel trial designs. Technological and methodological leaps in telemedicine can convert physical to virtual visits while routine examinations may be performed in local institutions (co-research centres), maintaining adherence to good clinical and research practices. The adoption of broader inclusion criteria and clinically significant endpoints (survival, quality of life) should be promoted, co-existing with pathways for fast-track “conditional” drug approvals in areas of unmet need, based on surrogate endpoints that are linked to strict post-approval validation requirements. The utility of Real World Data as part of these validation requirements should be actively investigated. Lessons learnt from the SARS Cov2 pandemic can be developed in order to expand equitable access to clinical trials of a real world population, in a simplified and methodologically robust modus operandi, for the benefit of all our patients.

Perfil genètic; Tumors sòlids; Adults; Precisió Perfil genético; Tumores sólidos; Adultos; Precisión Genetic profile; Solid tumors; Adults; Accuracy En aquest estudi s’ha definit la llista de gens per a cada patologia i tots ells han estat seleccionats atenent a; la seva utilitat diagnòstica per definir els subtipus tumorals en localitzacions tumorals molt concretes; la seva utilitat pronòstica i predictiva, sempre que això comporti un canvi d’actitud terapèutica; la seva utilitat terapèutica per a la indicació de l’ús de fàrmacs diana.

Programa d’oncologia de precisió; Implantació; Sistema sanitari públic Programa de oncología de precisión; Implantación; Sistema sanitario público Precision oncology Program; Implementation; Public health system El Programa d’oncologia de precisió comprèn un àmbit d’actuació que afecta totes aquelles alteracions moleculars o genètiques vinculades amb marcadors de pronòstic, predictors de la resposta terapèutica, la determinació de les quals condiciona la indicació d’un fàrmac més efectiu per al pacient, i també aquelles determinacions que comporten la identificació de alteracions relacionades amb la predisposició hereditària al càncer. El Programa de oncología de precisión comprende un ámbito de actuación que afecta a todas aquellas alteraciones moleculares o genéticas vinculadas con marcadores de pronóstico, predictores de la respuesta terapéutica, la determinación se condiciona la indicación de un fármaco más efectivo para el paciente , y también aquellas determinaciones que conllevan la identificación de alteraciones relacionadas con la predisposición hereditaria al cáncer. The Precision Oncology Program includes a field of action that affects all those molecular or genetic alterations linked to prognostic markers, predictors of the therapeutic response, the determination of which conditions the indication of a more effective drug for the patient, and also those determinations that involve the identification of alterations related to the hereditary predisposition to cancer.

Background Women represent an increasing proportion of the oncology workforce; however, globally this does not translate into leadership roles, reflecting disparities in career opportunities between men and women. The Spanish Society of Medical Oncology (SEOM) undertook a survey to investigate gender disparity in the Spanish oncology context. Design An online survey was made available to SEOM medical oncologists between February and May 2019. It included demographics, professional context and achievements, parenthood and family conciliation issues, workplace gender bias, and approaches to address disparities. Results Of the 316 eligible respondents, 71.5% were women, 59.5% were aged 45 or younger, and 66.1% had children. Among women, 12.4% were division or unit heads, compared with 45.5% of men, with most women (74.3%) being attending medical oncologists, compared with 45.5% of men. More males were professors (34.4% versus 14.2% of females), had a PhD (46.7% versus 28.8%), and/or had led clinical research groups (41.1% versus 9.7%). Spending time overseas after completing a residency was also more common for men than women (34.4% versus 20.4%). Professional satisfaction was similar between genders, driven primarily by patient care and intellectual stimulation. More women (40.7%) considered parenthood to have a strong negative impact on their career, compared with men (9.0%). Main perceived barriers to gender equality included a lack of work–life balance (72.6% women, 44.4% men), bias of peers and superiors (50.0% women, 18.9% men), and different career goals (41.2% women, 24.4% men). Preferred solutions included educational programs and scholarships (52.9%), communication and leadership training (35.8%), childcare at conferences (33.2%), and postmaternity return-to-work incentives (32.0%). Conclusion There is a clear paucity of equal opportunities for female oncologists in Spain. This can be addressed by encouraging professional development and merit recognition particularly for younger female oncologists, and empowering women to be involved in management and leadership of institutions and professional societies., Highlights • Under-representation of women in leadership roles in oncology is a widely acknowledged issue receiving global attention. • This study is a national description of leadership and educational opportunities in terms of gender and family circumstances. • Perceptions of gender bias in the workplace gender inequality or family conciliation issues and are described. • Initiatives for equal opportunities in oncology are needed supporting female academic career development and recognition.

Purpose The Spanish Society of Medical Oncology (SEOM) has carried out a study to analyse the conditions of access to oncology drugs in clinical practice in Spain. For the first time, the access of predictive biomarkers has also been analyzed. Methods A questionnaire was sent to 146 hospitals in Spain to collect information on the process of approval of 11 oncology drugs of an unquestionable clinical benefit and five predictive biomarkers of mandatory determination for specific treatments. Results Results highlight the still existing differences in the access of oncology drugs, as well as the newly identified differences in the access to predictive biomarkers between Autonomous Communities (AACC) in Spain, as well as between different hospitals within the same Autonomous Community. Conclusions The SEOM considers it necessary to reduce the differences identified, increase homogeneity, and improve conditions of access to oncology drugs and biomarkers, and makes proposals to address these issues.

Biosimilars; Oncologia; Prescriptors Biosimilares; Oncología; Prescriptores Biosimilars; Oncology; Prescribers Background: Biosimilars can potentially improve the sustainability of cancer care; however, uptake is sometimes limited by safety concerns and a lack of understanding of the concept of extrapolation. The European Society for Medical Oncology (ESMO) conducted a survey to assess the current level of knowledge, understanding and comfort of use of biosimilars among prescribers specialised in oncology. Methods: A 19-question survey was developed using the SurveyMonkey online platform (https://www.surveymonkey.com/). Data collection occurred between September and October 2017 and included paper and online responses. Results: Overall, 393 responses were received from prescribers. Overall, 49.0% of prescribers use biosimilars in clinical practice and most (79.2%) rate their general knowledge of biosimilars as average to very high. Potential increased risk of immunogenicity remains a significant concern of switching. Gaps in knowledge identified by the survey include biosimilar development, clinical trial design and endpoint selection, and requirements for extrapolation, which should form the focus of future educational initiatives. A substantial demand remains for further educational activities with equal preference for online and face-to-face initiatives. A higher rate of biosimilar use (56.3% vs 46.5%), knowledge of biosimilar development and trial design, and comfort with extrapolation, but a lower knowledge of European Medicines Agency definitions, was found among prescribers from Asia-Pacific versus those from Europe. Conclusion: Encouraging levels of prescriber use and general knowledge of biosimilars were found, but a substantial need for further education remains. Efforts should be made worldwide to align terms, definitions and guidelines for the development and approval of biosimilars.

BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, implementation, or data analysis and identify shortcomings in need of amendment. METHODS: As part of a refinement of the ESMO-MCBS, we reviewed trial design, implementation, and data analysis issues that could bias the results. For each issue of concern, we reviewed the ESMO-MCBS v1.1 approach against standards derived from Helsinki guidelines for ethical human research and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Food and Drugs Administration, the European Medicines Agency, and European Network for Health Technology Assessment. RESULTS: Six design, two implementation, and two data analysis and interpretation issues were evaluated and in three, the ESMO-MCBS provided adequate protections. Seven shortcomings in the ability of the ESMO-MCBS to identify and address bias were identified. These related to (i) evaluation of the control arm, (ii) crossover issues, (iii) criteria for non-inferiority, (iv) substandard post-progression treatment, (v) post hoc subgroup findings based on biomarkers, (vi) informative censoring, and (vii) publication bias against quality-of-life data. CONCLUSION: Interpretation of the ESMO-MCBS scores requires critical appraisal of trials to understand caveats in trial design, implementation, and data analysis that may have biased results and conclusions. These will be addressed in future iterations of the ESMO-MCBS., SCOPUS: re.j, info:eu-repo/semantics/published

Background COVID-19 appeared in late 2019, causing a pandemic spread. This led to a reorganisation of oncology care in order to reduce the risk of spreading infection between patients and healthcare staff. Here we analysed measures taken in major oncological units in Europe and the USA. Methods A 46-item survey was sent by email to representatives of 30 oncological centres in 12 of the most affected countries. The survey inquired about preventive measures established to reduce virus spread, patient education and processes employed for risk reduction in each oncological unit. Results Investigators from 21 centres in 10 countries answered the survey between 10 April and 6 May 2020. A triage for patients with cancer before hospital or clinic visits was conducted by 90.5% of centres before consultations, 95.2% before day care admissions and in 100% of the cases before overnight hospitalisation by means of phone calls, interactive online platforms, swab test and/or chest CT scan. Permission for caregivers to attend clinic visits was limited in many centres, with some exceptions (ie, for non-autonomous patients, in the case of a new diagnosis, when bad news was expected and for terminally ill patients). With a variable delay period, the use of personal protective equipment was unanimously mandatory, and in many centres, only targeted clinical and instrumental examinations were performed. Telemedicine was implemented in 76.2% of the centres. Separated pathways for COVID-19-positive and COVID-19-negative patients were organised, with separate inpatient units and day care areas. Self-isolation was required for COVID-19-positive or symptomatic staff, while return to work policies required a negative swab test in 76.2% of the centres. Conclusion Many pragmatic measures have been quickly implemented to deal with the health emergency linked to COVID-19, although the relative efficacy of each intervention should be further analysed in large observational studies., SCOPUS: ar.j, info:eu-repo/semantics/published

Adaptive designs; Umbrella protocols; Basket protocols Dissenys adaptatius; Protocols de paraigua; Protocols de cistell Diseños adaptativos; Protocolos de paraguas; Protocolos de cesto Cancer treatment has made significant strides towards the promise of personalized medicine. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing drugs targeting those deregulations irrespective of the tumour type. Precision cancer medicine was born out of accumulated evidence matching targeted agents with these tumour molecular deregulations. At the same time, the therapeutic armamentarium is rapidly increasing and the number of new drugs (including immune-oncology agents) entering drug development continues to rise. These factors, added to strong collaboration with regulatory agencies which have approved novel agents based on data obtained from Phase 1/2 trials, have led to unprecedented evolution in the design of early stage clinical trials. Currently, we have seen rapid Phase 1 dose escalation trials followed by remarkably large expansion cohorts, and are witnessing the emergence of new trials, such as adaptive studies with basket and umbrella designs aimed at optimizing the biomarker-drug co-development process. Alongside the growing complexity of these clinical trials, new frameworks for stronger and faster collaboration between all stakeholders in drug development, including academic institutions and frameworks, clinicians, pharma companies and regulatory agencies, have been established. In this review article, we describe the main challenges and opportunities that these new trial designs may provide for a more efficient drug development process, which may ultimately help ensure that precision cancer medicine becomes a reality for patients

Atenció oncològica; Àrees d'alta especialització; Model assistencial Atención oncológica; Áreas de alta especialización; Modelo asistencial Oncological care; Areas of high specialization; Assistance model L’objecte d’aquesta Instrucció és modificar la Instrucció 04/2018, del CatSalut, Reordenació de l’atenció oncològica d’alta especialització. El objeto de esta Instrucción es modificar la Instrucción 04/2018, del CatSalut, Reordenación de la atención oncológica de alta especialización. The purpose of this Instruction is to modify Instruction 04/2018, from CatSalut, Reordering of high-specialty oncology care.

Oncologia mèdica; Mentor resident; Càrrega de treball Oncología médica; Mentor residente; Carga de trabajo Medical oncology; Resident mentor; Workload Purpose: The Spanish Society for Medical Oncology (SEOM, for its acronym in Spanish) and the National Commission for the Specialty of Medical Oncology seek to highlight the important workload and unrecognized dedication entailed in working as a Medical Oncology (MO) resident mentor, as well as its relevance for the quality of teaching units and the future of the specialty. Materials and methods: The current situation and opinion regarding the activity of MO resident mentors was analyzed by reviewing the standing national and autonomic community regulations and via an online survey targeting mentors, residents, and physicians who are not MO mentors. The project was supervised by a specially designated group that agreed on a proposal containing recommendations for improvement. Results: Of the MO mentors, 90% stated that they did not have enough time to perform their mentoring duties. An estimated 172 h/year on average was dedicated to mentoring, which represents 10.1% of the total time. MO mentors dedicate an average of 6.9 h/month to these duties outside their workday. Forty-five percent of the mentors feel that their role is scantly recognized, if at all. Conclusions: The study reveals the substantial dedication and growing complexity of MO resident mentoring. A series of recommendations are issued to improve the conditions in which it is carried out, including the design of systems that adapt to the professional activity in those departments that have time set aside for mentoring tasks. This study was funded as an unrestricted grant by Servier. Servier did not have any intervention in the discussion and outcomes of this report.