Phase II study assesses the use of rituximab and bendamustine in frail, elderly DLBCL patients

On 10 May 2018, a study was published in Haematologica assessing the use of rituximab and bendamustine in combination as front line therapy for frail elderly patients with diffuse large B-cell lymphoma (DLBCL). The paper was published by Sergio Storti, Universita Cattolica Sacro Cuore Campbasso, Italy, and colleagues from the Fondazione Italiana Linfomi (Italian Lymphoma Foundation).

The phase II study (NCT01990144) evaluated the efficacy and safety of the combination of bendamustine and rituximab in patients with previously untreated DLBCL. Patients were defined as ‘frail’ in-line with the Comprehensive Geriatric Assessment (CGA). The study addressed an unmet need in this patient population for the treatment of frail elderly patients who are unable to be treated with the standard R-CHOP therapy.

Study Overview

• The open-label, non-randomized study assessed N = 45 patients (median age = 81 years; range, 71–89) from Italian centers
• Patients received 4-6 courses of bendamustine (90 mg/m², Days 1-2) and rituximab (375 mg/m², Day 1) administered every 28 days
• Primary endpoints included Complete Remission Rate (CR) and safety. Secondary endpoints included; overall response rate (ORR), progression-free survival (PFS) and overall survival (OS)

Key Findings

• Median follow-up = 33 months (range, 1–52)
• CR: 53% (95% CI, 38–68%)
  • Partial remission (n = 4)
• ORR: 62% (95% CI, 47–76%)
• 2-year PFS: 38% (95% CI, 24–51%)
  • Median PFS: 10 months (95% CI, 7–25)
• 2-year OS: 51% (95% CI, 35–65%)
  • Median OS: 30 months (95% CI, 10–not reached)
• Most common adverse event grade ≥3 was neutropenia 37.8%
  • 24 patients died during the study treatment and follow-up due to; lymphoma disease progression (58%) and unrelated causes

The authors concluded that they found the combination of bendamustine and rituximab to be a good treatment option showing “promising activity” for elderly frail patients with DLBCL. They noted that a larger sample size would be needed to further assess the PFS and OS in this treatment population.