Patients with chronic lymphocytic leukemia reported improved quality of life when treated with frontline Imbruvica and Rituxan, followed by continuous treatment with Imbruvica.
Patients with chronic lymphocytic leukemia (CLL) who received Imbruvica (ibrutinib) plus Rituxan (rituximab) in the frontline setting had improved quality of life, which was maintained with continuous Imbruvica therapy.
“The results of this quality-of-life analysis support the use of frontline Ibrutinib in previously untreated younger CLL patients,” said lead study author Dr. Priyanka Pophali, assistant professor at the University of Washington Carbone Cancer Center, during a presentation of the findings at the 2021 ASH Annual Meeting.
The randomized, phase 3 ECOG-ACRIN clinical trial E1912 established Imbruvica-Rituxan (IR) as the standard of care for patients with CLL age 70 or younger in the frontline setting. A secondary goal for this study was to see how the treatment affected patient quality of life. Researchers compared continuous IR with time-limited fludarabine, cyclophosphamide and Rituxan (FCR) therapy, “due to the differing profile of treatment-related toxicities over the short and long-term,” Pophali explained.
Patients who were enrolled in the trial completed the Functional Assessment of Cancer Therapy-General (FACT-G) — which is a patient-reported quality of life measure — and Leukemia subscale at randomization (baseline), three, six and 12 months post-randomization, and every six months for two years regardless of disease status.
Investigators measured the primary outcome with the FACT-Leukemia Trial Outcome Index (TOI), which is a 31-item questionnaire about patient quality of life with scores ranging from 0 to 124.
“The FACT-Leukemia trial outcome index is a summation of the factsheet physical well-being, functional well-being, and leukemia subscales,” Pophali said.
The primary endpoint was the difference in FACT-Leukemia TOI change scores from randomization to 12 months between patients treated with continuous therapy (group A) and patients treated with time-limited therapy (group B).
The patient-reported outcome (PRO) PRO data was provided at baseline and 12 months for 65.8% of patients in group A and 67.4% in group B.
At enrollment, there were no significant differences in the baseline FACT-Leukemia TOI scores between the two groups. The FACT-Leukemia TOI score improved from baseline to 12 months in both groups.
The change in scores from baseline to 12 months were not significantly different between group A and group B. Change in FACT-Leukemia TOI scores from baseline to three months was 5.77 and 4.06; and from baseline to six months was 6.87 and 8.01 in group A and group B, respectively.
The improvement in FACT-Leukemia TOI scores was maintained in both treatment groups after six months, with no major difference in total FACT-Leukemia TOI scores between the two groups over the first 36 months.
An analysis of the FACT subscales showed physical well-being improved in group A (0.37) and declined in group B (-0.92) from baseline to three months. There were, however, no significant differences in functional well-being and FACT-Leukemia subscales from baseline to three, six and 12 months.
Overall, the results showed that quality of life improvement is maintained during IR continuous therapy, and since the regimen was previously shown to improve progression-free survival and overall survival over FCR, these findings further support the use of IR in previously untreated patients with CLL, concluded Pophali.
A version of this article originally appeared on OncLive as “Frontline and Continuous Treatment With Ibrutinib Plus Rituximab Improves Quality of Life in Patients With CLL.”
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