A Phase II Study of Bendamustine Plus Rituximab in Patients with Relapsed or Progressive Marginal Zone Lymphoma: KCSG LY14-09.
[PURPOSE] This multicenter, phase II study examined the efficacy and safety of bendamustine plus rituximab in patients with relapsed or progressive marginal zone lymphoma (MZL).
APA
Lee JO, Park J, et al. (2025). A Phase II Study of Bendamustine Plus Rituximab in Patients with Relapsed or Progressive Marginal Zone Lymphoma: KCSG LY14-09.. Cancer research and treatment. https://doi.org/10.4143/crt.2025.815
MLA
Lee JO, et al.. "A Phase II Study of Bendamustine Plus Rituximab in Patients with Relapsed or Progressive Marginal Zone Lymphoma: KCSG LY14-09.." Cancer research and treatment, 2025.
PMID
41381062
Abstract
[PURPOSE] This multicenter, phase II study examined the efficacy and safety of bendamustine plus rituximab in patients with relapsed or progressive marginal zone lymphoma (MZL).
[MATERIALS AND METHODS] Patients received six cycles of bendamustine 90 mg/m2 intravenously on days 2 and 3, rituximab 375 mg/m2 intravenously in cycle 1, and 1,400 mg subcutaneously in cycles 2-8 on day 1 every 4 weeks. Bendamustine dose reduction to 60 mg/m2 (level -1) and 40 mg/m2 (level -2) was allowed based on prespecified toxicity criteria. The primary endpoint was overall response rate (ORR) and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
[RESULTS] Among the 26 evaluable patients, 81.8% achieved an ORR, while 40.7% had a complete response. The median PFS was 46.06 months, and the estimated 3-year OS rate was 92.3%. Hematological toxicities, primarily neutropenia (grade 3/4, 48.1%), were the most common adverse events, resulting in both reduction and interruption of bendamustine doses, accounting for 18 (75%) of 24 dose-reduced cycles and 7 (41%) of 17 missed cycles, respectively. Nonhematologic toxicities were generally mild, with nausea and fatigue identified as the most frequently reported toxicities. The mean relative dose intensities were 76.9% (range, 31.5-100) for bendamustine and 91.3% (range, 72.7-100) for rituximab.
[CONCLUSION] Bendamustine plus rituximab is a highly effective and tolerable treatment for patients with relapsed or progressive MZL, providing durable disease control.
[MATERIALS AND METHODS] Patients received six cycles of bendamustine 90 mg/m2 intravenously on days 2 and 3, rituximab 375 mg/m2 intravenously in cycle 1, and 1,400 mg subcutaneously in cycles 2-8 on day 1 every 4 weeks. Bendamustine dose reduction to 60 mg/m2 (level -1) and 40 mg/m2 (level -2) was allowed based on prespecified toxicity criteria. The primary endpoint was overall response rate (ORR) and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
[RESULTS] Among the 26 evaluable patients, 81.8% achieved an ORR, while 40.7% had a complete response. The median PFS was 46.06 months, and the estimated 3-year OS rate was 92.3%. Hematological toxicities, primarily neutropenia (grade 3/4, 48.1%), were the most common adverse events, resulting in both reduction and interruption of bendamustine doses, accounting for 18 (75%) of 24 dose-reduced cycles and 7 (41%) of 17 missed cycles, respectively. Nonhematologic toxicities were generally mild, with nausea and fatigue identified as the most frequently reported toxicities. The mean relative dose intensities were 76.9% (range, 31.5-100) for bendamustine and 91.3% (range, 72.7-100) for rituximab.
[CONCLUSION] Bendamustine plus rituximab is a highly effective and tolerable treatment for patients with relapsed or progressive MZL, providing durable disease control.