Provider Perceptions Impacting Treatment Choice in Mantel Cell Lymphoma (MCL): An Analysis of the Shine Trial Evaluating Ibrutinib + Bendamustine and Rituximab (I+BR) Versus Bendamustine and Rituximab (BR) in First-Line (1L)
Author(s)
Jeune-Smith Y1, Bone RN1, Baljevic M2, Baird S1, Feinberg B3
1Cardinal Health Specialty Solutions, Dublin, OH, USA, 2Vanderbilt University Medical Center, Nashville, TN, USA, 3Cardinal Health Specialty Solutions, ATLANTA, GA, USA
Presentation Documents
OBJECTIVES: The SHINE trial (NCT01776840) evaluating I+BR versus BR in 1L for transplant-ineligible patients aged ≥65 years with stage II-IV MCL met its primary endpoint of improved progression-free survival. The discontinuation rates in the I+BR and BR arms were similar (84% and 77% respectively) with more intolerance in the I+BR arm and more progression in the BR arm. Statistically significant clinical trial outcomes are not always clinically meaningful to prescribers, especially in chronic and life-threatening disease states where improved overall survival is not a demonstrated outcome. We conducted qualitative research to understand physicians’ perceptions of SHINE results and impact on future adoption.
METHODS: Two live summits in 2022 convened U.S.-based oncologists to review trial updates. Participants’ perceptions regarding the SHINE trial were collected in real-time using an electronic keypad, and demographic data were collected via a web-based survey. Descriptive statistics were used for analysis.
RESULTS: Eighty-four, primarily community-based (86%), physicians participated. These providers spend 89% of their working time in direct patient care and see approximately 18 patients/day. Most (73%) use 1L BR therapy for patients with MCL. After reviewing the SHINE data, most reported atrial fibrillation (75%) and bleeding (63%) adverse events as most concerning. Three-fourths said they were very (37%) or moderately (41%) likely to incorporate ibrutinib with BR therapy; 22% were not likely. When asked what reasons for discontinuation had greater influence on their treatment decisions, more physicians identified disease progression rates over intolerance rates (56% vs 39%).
CONCLUSIONS: Overall perceptions of the SHINE trial data were positive. Despite similar discontinuation rates in the I+BR and BR arms, physicians favored the I+BR regimen, 78% vs 22%. Second generation BTK inhibitors have demonstrably improved safety and efficacy profiles, and many physicians expressed a desire to see further studies of BTK inhibitors added to the BR therapy backbone as a potential future regimen.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
HSD56
Disease
No Additional Disease & Conditions/Specialized Treatment Areas