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Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study.

Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. European journal of cancer (Oxford, England : 1990) Dummer, R., Prince, H. M., Whittaker, S., Horwitz, S. M., Kim, Y. H., Scarisbrick, J., Quaglino, P., Zinzani, P. L., Wolter, P., Eradat, H., Pinter-Brown, L., Sanches, J. A., Ortiz-Romero, P. L., Akilov, O. E., Geskin, L., Huen, A., Walewski, J., Wang, Y., Lisano, J., Richhariya, A., Feliciano, J., Zhu, Y., Bunn, V., Little, M., Zagadailov, E., Dalal, M. R., Duvic, M. 2020; 133: 120–30

Abstract

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