Pain similar in doublet, triplet regimens for multiple myeloma
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ORLANDO – The addition of venetoclax to standard of care regimens in multiple myeloma did not increase the physical burden on patients, according to a poster presenter at the ASH Annual Meeting and Exposition.
“Patients with myeloma experience multiple disease related symptoms and impacts, especially those related to pain, fatigue and reduced physical function due to the high incidence of bone destruction, bone marrow failure and failure in immunodeficiency leading to the degradation of health-related quality of life,” Cristina Gasparetto, MD, of Duke University Medical Center, said during a recorded presentation of her poster.
Gasparetto and colleagues presented an interim analysis of the BELLINI trial performed at the cutoff of December 2018. This analysis included 291 patients randomized to receive either venetoclax (Venclexta; AbbVie, Genentech) with bortezomib (Velcade, Millenium/Takeda) and dexamethasone (n = 194) or to receive a placebo with bortezomib and dexamethasone (n = 97). This analysis aimed to measure the physical burden of participants in each arm.
The median exposure was 9.9 months in the venetoclax arm and 9.1 months in placebo arm. Follow-up time for OS was 19 months in the venetoclax arm and 18.3 in placebo arm.
In looking at the health-related quality of life scores, Gasparetto showed that change from baseline for both groups in the six categories were comparable. Physical functioning score lowered 9.1 in the venetoclax arm and 9.4 in placebo. Pain score changed by 0.1 in the venetoclax arm vs. 0.3 in placebo. Side effects from treatment increased by 7.9 in both groups. Quality of life score dropped by 7.1 in the venetoclax group and by 8.7 in the placebo group. Fatigue score increased by 9.9 in the treatment group and 7.8 in the placebo group. And the cancer fatigue T-score increased by 4.2 in the venetoclax arm and by 3.2 in the placebo arm.
“In the ITT population, comparable [European Organization for Research and Treatment of Cancer Quality of Life] and physical functioning scores over the course of the trial were observed between the two arms but the duration was likely less in the venetoclax-bortezomib arm compared to placebo,” she said. “In conclusion, the health-related quality of life measures reported in this study show that the addition of venetoclax to bortezomib-dexamethasone did not substantially increase patient symptom in function burden over and above bortezomib-dexamethasone alone. Physical function, worse pain, fatigue and side effects of treatment scores show that the outcomes were comparable, but deterioration was slightly less for those randomized to the venetoclax arm.” – by Katrina Altersitz
Reference: Gasparetto C, et al. Abstract 3177. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2019; Orlando.
Disclosures: Gasparetto reports financial relationships with Bristol Myers Squibb, Celgene and Janssen.