Importance of responder criteria for reporting health-related quality-of-life data in clinical trials for advanced cancer: recommendations of Common Sense Oncology and the European Organisation for Research and Treatment of Cancer.

The goals of treatment for people with advanced cancer are to prolong survival and improve symptoms and health-related quality of life (HRQOL). Although many phase 3 randomised clinical trials seek to evaluate HRQOL during treatment, informing individual patients about expected HRQOL outcomes is challenging, as the common method of analysis and reporting compares averages for randomised groups, and clinicians find these data difficult to apply in clinical practice. Symptomatic patients with advanced cancer would like to know the probability that a proposed treatment might improve their survival or their dominant symptoms, and the probability of having treatment-related side-effects.

Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials.

Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of randomised, controlled, phase 3 clinical trials evaluating cancer treatments. These principles include: (1) control treatment should be the best current standard of care; (2) the preferred primary endpoint is overall survival or a validated surrogate; (3) an absolute measure of benefit should be provided, such as the difference between groups in median overall survival times or the proportion of surviving patients at a prespecified time; (4) health-related quality of life should be at least a secondary endpoint; (5) toxicity should be described objectively without subjective language diminishing its importance; (6) trials should be designed to show or rule out clinically meaningful differences in outcomes, rather than a statistically significant difference alone; (7) censoring should be detailed, and sensitivity analyses done to determine its possible effects; (8) experimental treatments known to improve overall survival at later disease stages should be offered and funded for patients progressing in the control group; and (9) reports of trials should include a lay-language summary.

Ethical considerations in the relief of cancer pain.

The management of pain for patients with cancer and cancer survivors is a critical clinical task that involves a multitude of ethical issues at almost every phase of the cancer experience. This review is divided into three sections: In the first, we address rights and duties in the relief of pain from the perspective of patients, clinicians, health care institutions and organizations, and public policy. This section includes a detailed description of issues and duties in relation to opioid misuse and addiction.

Feasibility of Large-Scale Implementation of an Electronic Patient-Reported Outcome Remote Monitoring System for Patients on Active Treatment at a Community Cancer Center.

Purpose: The use of digital symptom monitoring with patient-reported outcomes (PROs) has been shown to improve patient outcomes. The evidence of benefit has been largely derived from research studies. The feasibility of adopting this technology in the real-world setting is unknown.

An appraisal of FDA approvals for adult solid tumours in 2017-2021: has the eagle landed?

In 2016, the then US President Barack Obama announced the Cancer Moonshot with a view to making 10 years' worth of progress in cancer prevention, diagnosis and treatment in only 5 years. This Perspective evaluates the FDA approvals of therapeutic agents for use in solid tumour oncology for the period 2017-2021 against the aspirations of the Cancer Moonshot. In the past 5 years, the FDA issued an unprecedented 161 new approvals of therapeutic agents for various indications in adult patients with solid tumours.

Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1.

Unlabelled: 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.

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

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.

Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score.

Purpose: To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) and the ASCO Value Framework Net Health Benefit score version 2 (ASCO-NHB v2), ESMO and ASCO collaborated to evaluate the concordance between the frameworks when used to assess clinical benefit attributable to new therapies.

Palliative care: needs of advanced breast cancer patients.

Advanced breast cancer is characterized by many physical manifestations with the potential to undermine the quality of life (most related to the cancer and some to treatments), as well as substantial impact on psychosocial well-being. Patients with advanced breast cancer and their families have complex needs that have to be addressed in order to minimize severe distress and deterioration in the quality of life of patients and their family members. This task requires the full engagement of an interdisciplinary approach to palliative care with strong emphasis on the assessment of needs and anticipated needs, patient expectations, skilled therapeutics, and commitment to continuity of care.

Indicators of integration at ESMO Designated Centres of Integrated Oncology and Palliative Care.

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.

Detailed statistical assessment of the characteristics of the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) threshold rules.

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.

ESMO gave me a chance to help make a difference: a personal reflection on the occasion of receiving the 2015 ESMO Award.

On the occasion of receiving the ESMO 2015, Prof Nathan Cherny reflects on the potential of the individual clinician to address issues of consequence on a wider scale through the auspices of a professional medical society. He describes his 20 year relationship with ESMO illustrating the potential of harnessing the power of ESMO to influence care, professional behaviours and distributional justice in the provision of care. He urges oncologists to be inspired by the credos that he was nurtured on emphasising professional and personal integrity and the audacity to push boundaries.

Experiences of Family Members of Dying Patients Receiving Palliative Sedation.

Purpose/objectives: To describe the experience of family members of patients receiving palliative sedation at the initiation of treatment and after the patient has died and to compare these experiences over time.
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Design: Descriptive comparative study.

Words matter: distinguishing "personalized medicine" and "biologically personalized therapeutics".

"Personalized medicine" has become a generic term referring to techniques that evaluate either the host or the disease to enhance the likelihood of beneficial patient outcomes from treatment interventions. There is, however, much more to personalization of care than just identifying the biotherapeutic strategy with the highest likelihood of benefit. In its new meaning, "personalized medicine" could overshadow the individually tailored, whole-person care that is at the bedrock of what people need and want when they are ill.