TY - JOUR
T1 - Quality of life and symptoms among patients with relapsed/refractory AL amyloidosis treated with ixazomib-dexamethasone versus physician's choice
AU - Sanchorawala, Vaishali
AU - Wechalekar, Ashutosh D.
AU - Kim, Kihyun
AU - Schönland, Stefan O.
AU - Landau, Heather J.
AU - Kwok, Fiona
AU - Suzuki, Kenshi
AU - Dispenzieri, Angela
AU - Merlini, Giampaolo
AU - Comenzo, Raymond L.
AU - Cherepanov, Dasha
AU - Hayden, Vanessa C.
AU - Kumar, Arun
AU - Labotka, Richard
AU - Faller, Douglas V.
AU - Kastritis, Efstathios
N1 - Publisher Copyright:
© 2023 Takeda Pharmaceutical Company and The Authors. American Journal of Hematology published by Wiley Periodicals LLC.
PY - 2023/5
Y1 - 2023/5
N2 - Patient-reported outcomes in AL amyloidosis have not been well-studied. We analyzed health-related quality of life (HRQOL) and AL amyloidosis symptoms data from the phase 3 TOURMALINE-AL1 trial (NCT01659658) (ixazomib-dexamethasone, n = 85; physician's choice of chemotherapy [PC], n = 83). HRQOL and symptom burden were measured with the SF-36v2, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-Ntx), and an amyloidosis symptom questionnaire (ASQ). Score changes during treatment were analyzed descriptively and using repeated-measures linear mixed models; analyses were not adjusted for multiplicity. Least-squares (LS) mean changes from baseline were significantly higher (better HRQOL) for ixazomib-dexamethasone at several cycles for SF-36v2 Role Physical and Vitality subscales (p <.05); no subscales demonstrated significant differences favoring PC. For FACT/GOG-Ntx, small but significant differences in LS mean changes favored ixazomib-dexamethasone over PC at multiple cycles for seven items and both summary scores; significant differences favored PC for one item (trouble hearing) at multiple cycles. ASQ total score trended downward (lower burden) in both arms; significant LS mean differences favored ixazomib-dexamethasone over PC at some cycles (p <.05). Patients with relapsed/refractory AL amyloidosis treated with ixazomib-dexamethasone experienced HRQOL and symptoms that were similar to or trended better than patients treated with PC despite longer duration of therapy.
AB - Patient-reported outcomes in AL amyloidosis have not been well-studied. We analyzed health-related quality of life (HRQOL) and AL amyloidosis symptoms data from the phase 3 TOURMALINE-AL1 trial (NCT01659658) (ixazomib-dexamethasone, n = 85; physician's choice of chemotherapy [PC], n = 83). HRQOL and symptom burden were measured with the SF-36v2, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-Ntx), and an amyloidosis symptom questionnaire (ASQ). Score changes during treatment were analyzed descriptively and using repeated-measures linear mixed models; analyses were not adjusted for multiplicity. Least-squares (LS) mean changes from baseline were significantly higher (better HRQOL) for ixazomib-dexamethasone at several cycles for SF-36v2 Role Physical and Vitality subscales (p <.05); no subscales demonstrated significant differences favoring PC. For FACT/GOG-Ntx, small but significant differences in LS mean changes favored ixazomib-dexamethasone over PC at multiple cycles for seven items and both summary scores; significant differences favored PC for one item (trouble hearing) at multiple cycles. ASQ total score trended downward (lower burden) in both arms; significant LS mean differences favored ixazomib-dexamethasone over PC at some cycles (p <.05). Patients with relapsed/refractory AL amyloidosis treated with ixazomib-dexamethasone experienced HRQOL and symptoms that were similar to or trended better than patients treated with PC despite longer duration of therapy.
UR - http://www.scopus.com/inward/record.url?scp=85148054664&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85148054664&partnerID=8YFLogxK
U2 - 10.1002/ajh.26866
DO - 10.1002/ajh.26866
M3 - Article
C2 - 36708469
AN - SCOPUS:85148054664
SN - 0361-8609
VL - 98
SP - 720
EP - 729
JO - American journal of hematology
JF - American journal of hematology
IS - 5
ER -