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4. Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) credit

Author

Oosting, S. F., Barriuso, J., Bottomley, A., Galotti, M., Gyawali, B., Kiesewetter, B., Latino, N. J., Martinelli, F., Pe, M., Pentheroudakis, G., Roitberg, F., Vachon, H., de Vries, E. G.E., Piccart, M., Cherny, N. I., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
quality of life, Oncology, ESMO-MCBS, guidelines, Hematology, checklist
Abstract

Background: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) has been developed to grade clinical benefit of cancer therapies. Improvement in quality of life (QoL) is considered relevant, especially in the non-curative setting. This is reflected by an upgrade of the preliminary ESMO-MCBS score if QoL is improved compared to the control arm or a downgrade if an improvement in progression-free survival is not paralleled by an improvement in QoL or overall survival. Given the importance of QoL for the final score, a need to ensure the robustness of QoL data was recognised. Design: A checklist was created based on existing guidelines for QoL research. Field testing was carried out using clinical trials that either received an adjustment of the preliminary ESMO-MCBS score based on QoL or had QoL as the primary endpoint. Several rounds of revision and re-testing of the checklist were undertaken until a final consensus was reached. Results: The final checklist consists of four items and can be applied if three prerequisites are met: (i) QoL is at least a secondary endpoint, (ii) evidence of reliability and validity of the instrument is provided, and (iii) a statistically and clinically significant improvement in QoL is observed. The four items on the checklist pertain to the (i) hypothesis, (ii) compliance and missing data, (iii) presentation of the results, and (iv) statistical and clinical relevance. Field testing revealed that a clear QoL hypothesis and correction for multiple testing were mostly lacking, while the main statistical method was always described. Conclusions: Implementation of the ESMO-MCBS QoL checklist will facilitate objective and transparent decision making on QoL data within the ESMO-MCBS scoring process. Trials published until 1 January 2025 will have to meet the prerequisites and at least two items for crediting QoL benefit in the final ESMO-MCBS score. Trials published thereafter will have to meet all four items.

Published
2023

5. ESMO-Magnitude of Clinical Benefit Scale for haematological malignancies (ESMO-MCBS:H) version 1.0

Author

Kiesewetter, B., Dafni, U., de Vries, E. G.E., Barriuso, J., Curigliano, G., González-Calle, V., Galotti, M., Gyawali, B., Huntly, B. J.P., Jäger, U., Latino, N. J., Malcovati, L., Oosting, S. F., Ossenkoppele, G., Piccart, M., Raderer, M., Scarfò, L., Trapani, D., Zielinski, C. C., Wester, R., Zygoura, P., Macintyre, E., Cherny, N. I., Kiesewetter, B., Dafni, U., de Vries, E. G.E., Barriuso, J., Curigliano, G., González-Calle, V., Galotti, M., Gyawali, B., Huntly, B. J.P., Jäger, U., Latino, N. J., Malcovati, L., Oosting, S. F., Ossenkoppele, G., Piccart, M., Raderer, M., Scarfò, L., Trapani, D., Zielinski, C. C., Wester, R., Zygoura, P., Macintyre, E., and Cherny, N. I.

Abstract

Background: The European Society for Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS) has been accepted as a robust tool to evaluate the magnitude of clinical benefit reported in trials for oncological therapies. However, the ESMO-MCBS hitherto has only been validated for solid tumours. With the rapid development of novel therapies for haematological malignancies, we aimed to develop an ESMO-MCBS version that is specifically designed and validated for haematological malignancies. Methods: ESMO and the European Hematology Association (EHA) initiated a collaboration to develop a version for haematological malignancies (ESMO-MCBS:H). The process incorporated five landmarks: field testing of the ESMO-MCBS version 1.1 (v1.1) to identify shortcomings specific to haematological diseases, drafting of the ESMO-MCBS:H forms, peer review and revision of the draft based on re-scoring (resulting in a second draft), assessment of reasonableness of the scores generated, final review and approval by ESMO and EHA including executive boards. Results: Based on the field testing results of 80 haematological trials and extensive review for feasibility and reasonableness, five amendments to ESMO-MCBS were incorporated in the ESMO-MCBS:H addressing the identified shortcomings. These concerned mainly clinical trial endpoints that differ in haematology versus solid oncology and the very indolent nature of nevertheless incurable diseases such as follicular lymphoma, which hampers presentation of mature data. In addition, general changes incorporated in the draft version of the ESMO-MCBS v2 were included, and specific forms for haematological malignancies generated. Here we present the final approved forms of the ESMO-MCBS:H, including instructions. Conclusion: The haematology-specific version ESMO-MCBS:H allows now full applicability of the scale for evaluating the magnitude of clinical benefit

Published
2023

12. Prioritising systemic cancer therapies applying ESMO's tools and other resources to assist in improving cancer care globally

Author

Latino, N J, Galotti, M, Cherny, N I, de Vries, E G E, Douillard, J-Y, Kaidarova, D, Ilbawi, A, and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Cancer Research, China, Oncology, Neoplasms, Humans, Immunotherapy, Medical Oncology
Abstract

BACKGROUND: In Kazakhstan, cancer is the second leading cause of death with a major public health and economic burden. In the last decade, cancer care and cancer medicine costs have significantly increased. To improve the efficiency and efficacy of cancer care expenditure and planning, the Kazakhstan Ministry of Health requested assistance from the World Health Organization (WHO) and the European Society for Medical Oncology (ESMO) to review its systemic cancer treatment protocols and essential medicines list and identify high-impact, effective regimens.MATERIALS AND METHODS: ESMO developed a four-phase approach to review Kazakhstan cancer treatment protocols: (i) perform a systematic analysis of the country's cancer medicines and treatment protocols; (ii) cross-reference the country's cancer protocols with the WHO Model List of Essential Medicines, the ESMO-Magnitude of Clinical Benefit Scale and the European Medicines Agency's medicine availability and indications database; (iii) extract treatment recommendations from the ESMO Clinical Practice Guidelines; (iv) expert review for all cancer medicines not on the WHO Model List of Essential Medicines and the country treatment protocols.RESULTS: This ESMO four-phase approach led to the update of the Kazakhstan national essential cancer medicines list and the list of cancer treatment protocols. This review has led to the withdrawal of several low-value or non-evidence-based medicines and a budget increase for cancer care to include all essential and highly effective medicines and treatment options.CONCLUSION: When applied effectively, this four-phase approach can improve access to medicines, efficiency of expenditure and sustainability of cancer systems. The WHO-ESMO collaboration illustrated how, by sharing best practices, tools and resources, we can address access to cancer medicines and positively impact patient care.

Published
2022

18. EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies

Author

Kiesewetter, B., Cherny, N. I., Boissel, Nicolas, Cerisoli, F., Dafni, U., De Vries, Elisabeth G. E., Ghia, Paolo, Gökbuget, N., González-Calle, Verónica, Huntly, B., Jäger, U., Latino, N. J., Douillard, Jean-Yves, Malcovati, L., Mateos, M. V., Ossenkoppele, G. J., Porkka, K., Raderer, M., Ribera, Jose-Maria, Scarfò, L., Wester, R., Zygoura, P., Sonneveld, P., Universitat Autònoma de Barcelona, Hematology, Radiotherapy, CCA - Cancer Treatment and quality of life, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Kiesewetter, Barbara [0000-0002-5490-2371], Apollo - University of Cambridge Repository, Kiesewetter, B., Cherny, N. I., Boissel, N., Cerisoli, F., Dafni, U., De Vries, E. G. E., Ghia, P., Gokbuget, N., Gonzalez-Calle, V., Huntly, B., Jager, U., Latino, N. J., Douillard, J. -Y., Malcovati, L., Mateos, M. -V., Ossenkoppele, G. J., Porkka, K., Raderer, M., Ribera, J. -M., Scarfo', L., Wester, R., Zygoura, P., Sonneveld, P., HUS Comprehensive Cancer Center, Hematologian yksikkö, and Helsinki University Hospital Area

Subjects
Cancer Research, medicine.medical_specialty, 3122 Cancers, value frameworks, ESMO-MCBS, Haematologic malignancies, Chronic lymphatic leukemia, Clinical benefit, 03 medical and health sciences, 0302 clinical medicine, QUALITY-OF-LIFE, Rating scale, Chronic leukaemia, REFRACTORY MULTIPLE-MYELOMA, Outcome Assessment, Health Care, medicine, Hematologic malignancy, Humans, ddc:610, Intensive care medicine, Grading (tumors), Societies, Medical, Original Research, 030304 developmental biology, RISK MYELODYSPLASTIC SYNDROMES, Solid tumour, 0303 health sciences, haematologic malignancies, business.industry, CHRONIC LYMPHOCYTIC-LEUKEMIA, Value frameworks, Myelodysplastic syndromes, clinical benefit, STEM-CELL TRANSPLANTATION, medicine.disease, LITY-OF-LIFE, 3. Good health, Clinical trial, LOW-DOSE CYTARABINE, Oncology, 030220 oncology & carcinogenesis, Hematologic Neoplasms, BORTEZOMIB-MELPHALAN-PREDNISONE, TRANSFUSION-DEPENDENT PATIENTS, OBINUTUZUMAB PLUS BENDAMUSTINE, business, NON-HODGKIN-LYMPHOMA
Abstract

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.

Published
2020

23. Access to essential anticancer medicines for children and adolescents in Europe

Author

Universitat Politècnica de València. Departamento de Mecánica de los Medios Continuos y Teoría de Estructuras - Departament de Mecànica dels Medis Continus i Teoria d'Estructures, European Commission, Vassal, G., Kozhaeva, O., Griskjane, S., Arnold, F., Nysom, K., Basset-Salom, Luisa, Kameric, L., Kienesberger, A., Kamal, S., Cherny, N., Bricalli, G., Latino, N., Kearns, P., Universitat Politècnica de València. Departamento de Mecánica de los Medios Continuos y Teoría de Estructuras - Departament de Mecànica dels Medis Continus i Teoria d'Estructures, European Commission, Vassal, G., Kozhaeva, O., Griskjane, S., Arnold, F., Nysom, K., Basset-Salom, Luisa, Kameric, L., Kienesberger, A., Kamal, S., Cherny, N., Bricalli, G., Latino, N., and Kearns, P.

Abstract

[EN] Background: Essential anticancer medicines are an indispensable component of multidisciplinary treatment of paediatric malignancies. A European Society for Medical Oncology (ESMO) study reported inequalities in the availability of anticancer medicines for adult solid tumours and provided a model for the present survey. The aim of this survey was to assess the accessibility of essential medicines used in paediatric cancer patients aged 0 to 18 years across Europe from 2016 to 2018. Methods: A list of medicines was drawn with input from the European Society for Paediatric Oncology (SIOP Europe) Clinical Research Council referring to the World Health Organization Model List of Essential Medicines for Children (WHO EMLc) 2017. A survey was sent to nominated national clinician and pharmacist rapporteurs and parent associations in up to 37 countries; answers were obtained from 34 countries. Results: The full survey list contained 68 medicines, including 24 on the WHO EMLc 2017. Health professionals reported that 35% of all medicines were prescribed off-label in at least one country and that 44% were always available in >90% of countries. Only 63% of the EMLc 2017 medicines were reported as always available. The main determinant of unavailability was shortages, reported for 72% of medicines in at least one country. Out-of-pocket costs were reported in eight countries. Twenty-seven percent of orally administered medicines were never available in childfriendly formulations. Parents detailed individual efforts and challenges of facilitating ingestion of oral medicines as prescribed. Inequalities in access to pain control during procedures were reported by parents across Europe. Conclusions: Children and adolescents with cancer in Europe experience lack of access to essential medicines. Urgent actions are needed to address shortages, financial accessibility, availability of safe age-appropriate oral formulations, and pain management across Europe.

Published
2021

32. ESMO Guidelines: Cancer patient management during the COVID-19 pandemic

Author

Aapro, M., Addeo, A., Acierto, P., Balermpas, P., Berg, T., Berghoff, A., Betella, I., Blay, J. -Y., Bosetti, D. G., Bossi, P., Bouchaab, H., Brandt, J., Buske, C., Caraceni, A., Cardoso, F., Carles, J., Catanese, S., Cherny, N., Colombo, I., Colombo, N., Cortes, J., Criscitiello, C., Curigliano, G., de Azambuja, E., Delagoge, S., Del Grande, M., De Santis, M., Douillard, J. -Y., Dummer, R., Dziadziuszko, R., Escudier, B., Fizazi, K., Fleitas, T., Franceschi, E., Hoeller, C., Gillessen, S., Gonzalez Martin, A., Gralla, R., Grigorescu, A., Gronchi, A., Hassan, A., Hui, D., Jerkeman, M., Jones, R., Jordan, K., Keilholz, U., Kreye, G., Ledermann, J., Loibl, S., Lordick, F., Lorigan, P., Loriot, Y., Machiels, J. -P., Broto, J. M., Mei, U., Michielin, O., Mori, M., Multinu, F., Paluch-Shimon, S., Parker, C., Passaro, A., Pentheroudakis, G., Peters, S., Piazza, C., Porta, C., Powles, T., Preusser, M., Reck, M., Ripamonti, C., Rubach, M., Rukhadze, T., Schmidinger, M., Sensus-Konefka, E., Sessa, C., Shaulov, A., Stacchiotti, S., Stevens, A. -M., Stintzing, S., Szturz, P., Trapani, D., van Akkooi, A., Vecchione, L., van Bommel, F., Vogl, U., Von Garnier, C., Weller, M., Wood, J., Zaccarelli, E., and Zimmermann, C.

Published
2020

33. Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus

Author

Curigliano, G., Banerjee, S., Cervantes, A., Garassino, M. C., Garrido, P., Girard, N., Haanen, J., Jordan, K., Lordick, F., Machiels, J. P., Michielin, O., Peters, S., Tabernero, J., Douillard, J. Y., Pentheroudakis, G., Addeo, A., Albiges, L., Ascierto, P. A., Barlesi, F., Caldas, C., Cardoso, F., Chaberny, I. F., Cherny, N. I., Choueiri, T. K., Chua, M. L. K., Criscitiello, C., de Azambuja, E., De Ruysscher, D., de Vries, E., Dent, R., D'Ugo, D., Dziadziuszko, R., Faivre-Finn, C., Felip, E., Garassino, M., Glynne-Jones, R., Golfinopoulos, V., Hamilton, E., Janne, P. A., Kanesvaran, R., Kim, S. B., Liebert, U. G., Mok, T. S. K., Morgan, G., Obermannova, R., Park, K., Passaro, A., Reck, M., Salazar Soler, R., Scotte, F., Senan, S., Sessa, C., Smyth, E., Soo, R., Soria, J. C., Spicer, J., Strasser, F., Tan, D. S. W., Trapani, D., Van Cutsem, E., van Halteren, H., van Schil, P. E., Veronesi, G., Yang, J., de Vries E., D'Ugo D. (ORCID:0000-0001-6657-6318), Curigliano, G., Banerjee, S., Cervantes, A., Garassino, M. C., Garrido, P., Girard, N., Haanen, J., Jordan, K., Lordick, F., Machiels, J. P., Michielin, O., Peters, S., Tabernero, J., Douillard, J. Y., Pentheroudakis, G., Addeo, A., Albiges, L., Ascierto, P. A., Barlesi, F., Caldas, C., Cardoso, F., Chaberny, I. F., Cherny, N. I., Choueiri, T. K., Chua, M. L. K., Criscitiello, C., de Azambuja, E., De Ruysscher, D., de Vries, E., Dent, R., D'Ugo, D., Dziadziuszko, R., Faivre-Finn, C., Felip, E., Garassino, M., Glynne-Jones, R., Golfinopoulos, V., Hamilton, E., Janne, P. A., Kanesvaran, R., Kim, S. B., Liebert, U. G., Mok, T. S. K., Morgan, G., Obermannova, R., Park, K., Passaro, A., Reck, M., Salazar Soler, R., Scotte, F., Senan, S., Sessa, C., Smyth, E., Soo, R., Soria, J. C., Spicer, J., Strasser, F., Tan, D. S. W., Trapani, D., Van Cutsem, E., van Halteren, H., van Schil, P. E., Veronesi, G., Yang, J., de Vries E., and D'Ugo D. (ORCID:0000-0001-6657-6318)

Abstract

We established an international consortium to review and discuss relevant clinical evidence in order to develop expert consensus statements related to cancer management during the severe acute respiratory syndrome coronavirus 2-related disease (COVID-19) pandemic. The steering committee prepared 10 working packages addressing significant clinical questions from diagnosis to surgery. During a virtual consensus meeting of 62 global experts and one patient advocate, led by the European Society for Medical Oncology, statements were discussed, amended and voted upon. When consensus could not be reached, the panel revised statements until a consensus was reached. Overall, the expert panel agreed on 28 consensus statements that can be used to overcome many of the clinical and technical areas of uncertainty ranging from diagnosis to therapeutic planning and treatment during the COVID-19 pandemic.

Published
2020

47. Euthanasia and palliative care

Author

Cherny, N, Fallon, M, Kaasa, S, Portenoy, R, Currow, D, Cherny, N ( N ), Fallon, M ( M ), Kaasa, S ( S ), Portenoy, R ( R ), Currow, D ( D ), Materstvedt, Lars Johan, Bosshard, Georg, Cherny, N, Fallon, M, Kaasa, S, Portenoy, R, Currow, D, Cherny, N ( N ), Fallon, M ( M ), Kaasa, S ( S ), Portenoy, R ( R ), Currow, D ( D ), Materstvedt, Lars Johan, and Bosshard, Georg

Abstract

This chapter focuses on the particular relationship and interconnections between euthanasia and palliative care. Selected key data on assisted dying are presented. Of central importance is the question of how requests for assisted dying should be handled within palliative care, and as part of addressing this question the chapter includes a discussion of the practice in Belgium, where euthanasia is performed within palliative care institutions. Furthermore, the chapter presents the Swiss model, which practises a much clearer separation between assisted dying and both palliative care and clinical medical practice. Statements on assisted dying made by key palliative care organizations are then presented and analysed. The chapter asks whether the palliative care community will be more accepting of euthanasia in the future, following potential new legislation. The concluding remarks consider the current reluctance of doctors to participate, and the pressures they are under to accept a role, in assisted dying.

Published
2015

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