BACKGROUND: Brentuximab vedotin was approved for adult patients with CD30-expressingcutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8mg/kg once every 3 weeks; =16 cycles) versus physician's choice (methotrexate/bexarotene; =48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.METHODS: QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.RESULTS: Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p<0.001), exceeded the study-defined minimally important difference (9.0-12.3). Meanchanges from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were alsocomparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.CONCLUSIONS: In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffectedby the presence of PN in brentuximab vedotin-treated patients.CLINICAL TRIAL REGISTRATION: NCT01578499.
View details for DOI 10.1016/j.ejca.2020.04.010
View details for PubMedID 32502876