TY - JOUR
T1 - Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab
T2 - Results from the ANDROMEDA study
AU - Sanchorawala, Vaishali
AU - Palladini, Giovanni
AU - Minnema, Monique C.
AU - Jaccard, Arnaud
AU - Lee, Hans C.
AU - Gibbs, Simon
AU - Mollee, Peter
AU - Venner, Christopher
AU - Lu, Jin
AU - Schönland, Stefan
AU - Gatt, Moshe
AU - Suzuki, Kenshi
AU - Kim, Kihyun
AU - Cibeira, María Teresa
AU - Beksac, Meral
AU - Libby, Edward
AU - Valent, Jason
AU - Hungria, Vania
AU - Wong, Sandy W.
AU - Rosenzweig, Michael
AU - Bumma, Naresh
AU - Chauveau, Dominique
AU - Gries, Katharine S.
AU - Fastenau, John
AU - Tran, Nam Phuong
AU - Qin, Xiang
AU - Vasey, Sandra Y.
AU - Weiss, Brendan M.
AU - Vermeulen, Jessica
AU - Ho, Kai Fai
AU - Merlini, Giampaolo
AU - Comenzo, Raymond L.
AU - Kastritis, Efstathios
AU - Wechalekar, Ashutosh D.
N1 - Publisher Copyright:
© 2022 Wiley Periodicals LLC.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - 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.
AB - 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.
KW - Amyloidosis/drug therapy
KW - Antibodies, Monoclonal
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Bortezomib
KW - Cyclophosphamide
KW - Dexamethasone
KW - Humans
KW - Immunoglobulin Light-chain Amyloidosis/drug therapy
KW - Multiple Myeloma/drug therapy
KW - Quality of Life
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85127350368&partnerID=8YFLogxK
U2 - 10.1002/ajh.26536
DO - 10.1002/ajh.26536
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C2 - 35293006
AN - SCOPUS:85127350368
SN - 0361-8609
VL - 97
SP - 719
EP - 730
JO - American Journal of Hematology
JF - American Journal of Hematology
IS - 6
ER -