Τίτλος:
Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study
Περίληψη:
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.
Συγγραφείς:
Sanchorawala, V.
Palladini, G.
Minnema, M.C.
Jaccard, A.
Lee, H.C.
Gibbs, S.
Mollee, P.
Venner, C.
Lu, J.
Schönland, S.
Gatt, M.
Suzuki, K.
Kim, K.
Cibeira, M.T.
Beksac, M.
Libby, E.
Valent, J.
Hungria, V.
Wong, S.W.
Rosenzweig, M.
Bumma, N.
Chauveau, D.
Gries, K.S.
Fastenau, J.
Tran, N.P.
Qin, X.
Vasey, S.Y.
Weiss, B.M.
Vermeulen, J.
Ho, K.F.
Merlini, G.
Comenzo, R.L.
Kastritis, E.
Wechalekar, A.D.
