Patient-reported Outcomes in Lymphoma Clinical Trials Are Recognized as Important Tools

Patient-reported Outcomes in Lymphoma Clinical Trials Are Recognized as Important Tools

Patient-reported outcomes in clinical trials of brentuximab vedotin for Hodgkin lymphoma (HL) and anaplastic large-cell lymphoma (ALCL) show improvements in patients’ health-related quality of life, emphasizing their importance for patient management and assessing treatment outcomes.

The study, “Patient-reported outcomes of brentuximab vedotin in Hodgkin lymphoma and anaplastic large-cell lymphoma,” was published in the journal OncoTargets and Therapy.

Patients with relapsed/refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large-cell lymphoma (sALCL) treated with brentuximab vedotin experienced high remission rates in two pivotal Phase 2 multicenter, open-label clinical trials.

In randomized clinical trials, the most common endpoint analyzed is overall survival and disease-free survival. However, the role for patient-reported outcomes when considering treatment decisions and enhancing quality of care is becoming increasingly recognized.

To understand how brentuximab vedotin impacts the quality of life of patients who have survived HL or sALCL, researchers developed a brief eight-question survey and collected patient reports of quality of life in the post-treatment period for R/R HL or sALCL in two pivotal studies.

a total of 25 patients (12 with HL, 13 with sALCL) completed the eight-question survey. In general, patients’ response was very positive concerning brentuximab vedotin treatment, reporting significant improvements (when compared to the period before treatment) in energy level, outlook on life, difficulties with daily activities, ability to participate in physical activities, and overall health-related quality of life.

The authors recognize, however, that the current study has several limitations: a small sample size, lack of a baseline questionnaire for comparisons, use of a non-validated assessment instrument, and reliance on patient recall of five years from the first dose of brentuximab vedotin.

Despite the limitations, the team noted that these results suggest an overall improvement on patients’ quality of life after brentuximab vedotin therapy. The patients appear to lead lives with few limitations on daily functioning, emotional well-being, and work life.

According to these results, patient-reported outcomes are an effective tool for ongoing and future brentuximab vedotin trials to help physicians, caregivers, and patients through treatment and to assure survivorship. Validating these patient-reported outcomes will allow researchers to determine the value of brentuximab vedotin in earlier lines of therapy.

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