|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Hematology Advisor’s conference coverage.|
Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaires as the measure, more patients with Waldenström macroglobulinemia showed a benefit after receiving ibrutinib-rituximab compared with placebo-rituximab, and patient-reported outcome benefits increased over time, according to research presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Researchers sought to further evaluate data on patient-reported outcomes from the iNNOVATE study in order to assess patients’ perspectives on the therapeutic benefit across both treatment arms.
Baseline patient characteristics and patient-reported outcome scores were well balanced between the ibrutinib-rituximab arm (75 patients) and the placebo-rituximab arm (75 patients). The most common reasons that patients reported for the initiation of treatment for Waldenström macroglobulinemia were fatigue, hemoglobin below 10 g/dL, constitutional symptoms, serum IgM greater than 50 g/L, and peripheral neuropathy.
The mean patient-reported outcomes were typically similar across both treatment arms, and no substantial difference in the effect of treatment was seen across the study. After a median follow-up of 26.5 months, more patients showed a clinically meaningful improvement in the ibrutinib-rituximab arm compared with the placebo-rituximab arm using FACIT-F (69% vs 57%, respectively), FACT-An total score (73% vs 59%, respectively), and FACT-An anemia subscale score (64% vs 48%, respectively) as measures.
The researchers found that the median time to clinically meaningful patient-reported outcomes was short across the study (1-2 months).
“Reductions in serum IgM levels were found to correlate with improvements in patient-reported outcomes in patients treated with ibrutinib-rituximab, and the clinical responses and improvement in IgM and hemoglobin levels observed with ibrutinib-rituximab treatment are consistent with the improvements in patient-reported outcomes reported by these patients,” the researchers concluded.
1. Tedeschi A, Dimopoulos MA, Trotmanet J, et al. Patient-reported outcomes (PROs) with ibrutinib-rituximab in Waldenström macroglobulinemia (WM): Results from iNNOVATE. Poster presentation at: 2019 ASCO Annual Meeting; June 3, 2019; Chicago, IL. Abstract 8018.