Info
ibrutinib_plus_bendamustine_and_rituximab_in_untreated_mantle-cell_lymphoma
Wang ML, Jurczak W, Jerkeman M, et al. Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. New England Journal of Medicine. 2022;386(26):2482-2494. doi:10.1056/nejmoa2201817
✨ SHINE trial: PFS 有幫助，但 OS 沒差！
- Design:
- Trial phase: III
- Multi-center
- Randomized
- Open-label
- Number of patients: 523
- Patients characteristics: Patients 65 years of age or older with untreated mantle-cell lymphoma
- Agent:
- Intervention: Ibrutinib (560 mg, orally once daily) in combination with bendamustine (90 mg per square meter) and rituximab (375 mg per square meter)
- Control: Placebo in combination with bendamustine and rituximab
- Treatment line: First-line therapy
- Trial Acronym or NCTId Number: NCT01776840
- Comparison of outcomes:
| Outcome | Ibrutinib Group | Placebo Group |
|---|---|---|
| Progression-free survival (PFS) | 80.6 months | 52.9 months |
| Overall survival (OS) | 55.0% at 7 years | 56.8% at 7 years |
| Response rate (RR) | 65.5% Complete Response | 57.6% Complete Response |