Cancer related fatigue and the additive effect of treatment in the context of lymphoma: An analysis of the Lymphoma Coalition's 2022 Global Patient Survey.

Cancer related fatigue (CRF) continues to be a challenging phenomenon that is often under-reported and poorly understood. With etiologies in both disease and treatment manifesting as a symptom and a side-effect respectively, CRF is highly incident and presents a significant clinical problem that impacts survivorship. We conducted a survey to ascertain the patient reported incidence of symptoms and side-effects for people with lymphoma or chronic lymphocytic leukemia (CLL). We found that CRF was enhanced in those who received more intense therapies that coincided with more aggressive lymphoma subtypes. This data illuminates an unmet need amongst patients with lymphoma and provides an opportunity to further refine treatment regimens in order to reduce the burden of CRF in this vulnerable population.

End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?

We observed lack of clarity and consistency in end point definitions of large randomized clinical trials in diffuse large B-cell lymphoma. These inconsistencies are such that trials might, in fact, address different clinical questions. They complicate interpretation of results, including comparisons across studies. Problems arise from different ways to account for events occurring after randomization including absence of improvement in disease status, treatment discontinuation or the initiation of new therapy. We call for more dialogue between stakeholders to define with clarity the questions of interest and corresponding end points. We illustrate that assessing different end point rules across a range of plausible patient journeys can be a powerful tool to facilitate such a discussion and contribute to better understanding of patient-relevant end points.

What is this article about? This article talks about the lack of clarity and consistency in the definitions of outcomes used in clinical trials that investigate new treatments for diffuse large B-cell lymphoma. This is mainly due to how these different outcome definitions handle events such as absence of improvement in disease status, treatment discontinuation or initiation of new treatment. The authors discuss how these inconsistencies make it hard to interpret the results of individual clinical trials and to compare results across clinical trials.Why is it important? Defining the above events and consequently defining outcomes affects what we can learn from the trials and can lead to different results. Some approaches may not reflect good and bad outcomes for patients appropriately. This makes it challenging for patients, physicians, health authorities and payors to understand the true benefit of treatments under investigation and which one is better.What are the key take-aways? This article serves as a call-to-action for more dialogue among all stakeholders involved in drug development and the decision-making process related to drug evaluations. There is an urgent need for clinical trials to be designed with more clarity and consistency on what is being measured so that relevant questions for patients and prescribing physicians are addressed. Understanding patient journeys will be key to successfully understand what truly matters to patients and how to measure the benefit of new treatments. Such discussions will contribute toward more clarity and consistency in the evaluation of new treatments.