PATIENT‐REPORTED OUTCOMES AND QUALITY OF LIFE IN PATIENTS WITH CUTANEOUS T CELL LYMPHOMA: RESULTS FROM THE PHASE 3 ALCANZA STUDY

Abstract

Introduction: As cutaneousT-cell lymphoma (CTCL) is a chronic, incurable disease, maintaining quality of life (QoL) is a key issue; yet CTCL is associated with significant symptom burden, including pruritus and skin lesions that are highly detrimental to patients' (pts) well-being. The Phase 3 ALCANZA study showed significantly improved rate of objective response lasting ≥4 months (ORR4) with decreased symptom burden in CD30-positive (CD30+) CTCL treated with brentuximab vedotin (BV) vs physician's choice (PC) of methotrexate (MTX) or bexarotene (Bex). Here, we further examine QoL in pts enrolled to the ALCANZA study. Methods: Adults with previously treated CD30+ mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL) were randomized 1:1 to BV 1.8 mg/kg IV, Q3W, or PC for up to 16 three-week cycles. Patient-reported outcomes included Skindex-29 (symptom domain, key secondary endpoint; emotion and functioning domains, secondary endpoints), FACT-G (secondary endpoint), and EQ-5D (exploratory endpoint) questionnaires, administered on day 1 of cycles 1, 2, 4, 6, 8, 10, 12, 14, and 16, at end of treatment (EOT), and during post-treatment follow-up in the intent-to-treat (ITT) population. Minimally important differences (MID) for Skindex-29 symptom domain were estimated to be 9.0-12.3 using distribution-based methods. Scores were also summarized with descriptive statistics. Associations between QoL scores and clinical response or peripheral neuropathy (PN, a known BV toxicity) were also assessed. Results: In total, 128 pts were included in the ITT population (97 MF, 31 pcALCL). Skindex-29 showed significantly greater symptom reduction in the BV arm compared with the PC arm, with a mean maximum reduction of -27.96 versus -8.62, respectively; a difference of -18.9 (95% CI: -26.6, -11.2; adjusted p < 0.001), which exceeds the MID. In the BV arm, mean change from baseline symptom burden score decreased ≥MID by cycle 4 lasting until EOT. Such a decrease was not observed in the PC arm. The majority of pts in the BV arm had reductions in symptom burden, regardless of CR/ PR status. Among BV pts, mean maximum reduction in Skindex-29 symptom domain in pts with PN was -35.54 vs -11.11 in pts with no PN; mean maximum reductions in symptom burden were similar in pts with Grade 2/3 PN (-36.72) vs Grade 1 PN (-33.33). Mean change from baseline of FACT-G total scores were similar between BV (0.15) and PC (-2.29) arms. No substantial differences in QoL were observed on EQ-5D US time trade-off (TTO), UK TTO, or visual analog scores, and the mean changes from baseline to EOT visit in the BV arm were 0.02, 0.03, 0.8 compared to -0.02, -0.04, -2.0 in the PC arm. Conclusions: BV did not adversely affect QoL in CTCL pts compared with MTX or Bex, and QoL was unaffected by the presence of PN in pts receiving BV. Superior reductions in symptom burden were observed in the BV arm. Skin-symptom reductions were rapid and durable.