Abstract
BackgroundBrentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/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. MethodsQoL 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. ResultsMean 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). Mean changes 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 also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was –35.54 versus –11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores. ConclusionsIn summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients. Clinical trial registrationNCT01578499.
Highlights
Cutaneous T-cell lymphomas (CTCLs) are a heterogeneous group of non-Hodgkin lymphomas characterised by clonal T-cell skin infiltrations [1,2]
A 2005 survey of the US National Cutaneous Lymphoma Foundation reported that 41% of patients felt that CTCL had impacted work or school attendance, and 53% had experienced some degree of depression as a result of their disease [9]
The ongoing evaluation of patient-reported outcome (PRO) for symptom burden and Quality of life (QoL) is essential to ascertain if a treatment can improve and maintain patient well-being, and such measures should be routinely assessed in clinical trials for CTCL [25,26]
Summary
Cutaneous T-cell lymphomas (CTCLs) are a heterogeneous group of non-Hodgkin lymphomas characterised by clonal T-cell skin infiltrations [1,2]. Because of the chronic recurrent nature of CTCL, complete responses (CRs) to treatment are rare, and patients frequently experience skin relapses or become treatment-refractory [5e7]. Brentuximab vedotin, a CD30-targeting antibodye drug conjugate, is approved in Europe and the United States of America (USA) for treatment of CTCL patients, including pcALCL and CD30-expressing MF, who have received prior systemic therapy [11,12]. Approval was granted based on the phase III ALCANZA trial results (NCT01578499), demonstrating significantly improved objective response with brentuximab vedotin versus physician’s choice (PC; methotrexate or bexarotene) in patients with previously treated CD30-expressing MF or pcALCL (56.3% versus 12.5%; p < 0.0001) [13], and an acceptable safety profile that was consistent with that in other malignancies. To reflect the importance of QoL in CTCL, ALCANZA evaluated patient-reported outcome (PRO) measures; results are reported here
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