Quality of life and symptoms among patients with relapsed/refractory AL amyloidosis treated with ixazomib‐dexamethasone versus physician's choice

Abstract

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.

Cardiovascular toxicity from therapies for light chain amyloidosis

“…Patients treated with ixazomib showed an increased risk of cardiac arrhythmias (26% vs. 15%), but the Authors assessed that the difference was mainly due to the greater frequency of non-drug-related atrial fibrillation (8% vs. 1%) ( 100 ). Although the study did not meet the primary endpoints of hematologic response, further analysis revealed that ixazomib administration is associated with similar or trended better quality of life and symptoms manifestation, compared with control regimens ( 101 ). In a phase I/II study, ixazomib-cyclophosphamide-dexamethasone was safe and well tolerated in patients with a new diagnosis of AL amyloidosis ( 102 ).…”

Survivorship among patients with haematological cancer: Work disability, dementia, and neuropathy

“…We chose to include the FACT/GOG-Ntx-13 as it holds information on both quality of life and neuropathy. It was not originally developed for haematological cancers, but it has been widely used in other studies within this patient group (155,169,(260)(261)(262). The questionnaire is considered among the best PROs to capture CIPN (166,185,263,264).…”