TY - JOUR
TI - Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study
AU - Sanchorawala, V.
AU - Palladini, G.
AU - Minnema, M.C.
AU - Jaccard, A.
AU - Lee, H.C.
AU - Gibbs, S.
AU - Mollee, P.
AU - Venner, C.
AU - Lu, J.
AU - Schönland, S.
AU - Gatt, M.
AU - Suzuki, K.
AU - Kim, K.
AU - Cibeira, M.T.
AU - Beksac, M.
AU - Libby, E.
AU - Valent, J.
AU - Hungria, V.
AU - Wong, S.W.
AU - Rosenzweig, M.
AU - Bumma, N.
AU - Chauveau, D.
AU - Gries, K.S.
AU - Fastenau, J.
AU - Tran, N.P.
AU - Qin, X.
AU - Vasey, S.Y.
AU - Weiss, B.M.
AU - Vermeulen, J.
AU - Ho, K.F.
AU - Merlini, G.
AU - Comenzo, R.L.
AU - Kastritis, E.
AU - Wechalekar, A.D.
JO - American Journal of Hematology
PY - 2022
VL - 97
TODO - 6
SP - 719-730
PB - John Wiley and Sons Inc
SN - 0361-8609, 1096-8652
TODO - 10.1002/ajh.26536
TODO - null
TODO - In the phase 3 ANDROMEDA trial, patients treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone (D-VCd) had significantly higher rates of organ and hematologic response compared with patients who received VCd alone. Here, we present patient-reported outcomes (PROs) from the ANDROMEDA trial. PROs were assessed through cycle 6 using three standardized questionnaires. Treatment effect through cycle 6 was measured by a repeated-measures, mixed-effects model. The magnitude of changes in PROs versus baseline was generally low, but between-group differences favored the D-VCd group. Results were generally consistent irrespective of hematologic, cardiac, or renal responses. More patients in the D-VCd group experienced meaningful improvements in PROs; median time to improvement was more rapid in the D-VCd group versus the VCd group. After cycle 6, patients in the D-VCd group received daratumumab monotherapy and their PRO assessments continued, with improvements in health-related quality of life (HRQoL) reported through cycle 19. PROs of subgroups with renal and cardiac involvement were consistent with those of the intent-to-treat population. These results demonstrate that the previously reported clinical benefits of D-VCd were achieved without decrement to patients' HRQoL and provide support of D-VCd in patients with AL amyloidosis. © 2022 Wiley Periodicals LLC.
ER -