Background:Background: Indolent non-Hodgkin lymphoma is typically responsive to initial immune-chemotherapy, but it is also prone to persistent recurrence. Bendamustine, an alkylating agent with properties of a purine analog, has been approved for first-line treatment of indolent non-Hodgkin lymphoma in Japan. Although China has approved the second-line treatment of bendamustine for indolent B-cell non-Hodgkin lymphoma in 2019, evidence of bendamustine as first-line treatment for this patient population in China is still scanty currently.
Aims:Aims: To evaluate the efficacy and safety of bendamustine-based regimens as first-line treatment for Chinese patients with indolent B-cell non-Hodgkin lymphoma in real-world setting.
Methods:Methods: Treatment-naïve patients with indolent B-cell non-Hodgkin lymphoma were enrolled in this prospective, multicenter, single-arm, real-world study (ChiCTR2000039605). Eligible patients will be given 4-6 cycles (4 weeks/cycle) of bendamustine-based regimens including bendamustine monotherapy (90 mg/m 2 on Day 1-2), bendamustine (90 mg/m 2 on Day 1-2) plus rituximab (375 mg/m 2 on Day 1), bendamustine (70 mg/m 2 on Day 1-2) plus rituximab and cytarabine (500 mg/m 2 on Day 2-4), or bendamustine (90 mg/m 2 on Day 1-2) plus rituximab and bortezomib (1.6 mg/m 2 on Day 1, 8 and 15). Tumor response was assessed by independent central review according to Lugano 2014 response criteria. Primary endpoint was objective response rate (ORR). Secondary endpoints were disease control rate (DCR) and safety.
Results:Results: Between December 2019 and February 2022, 29 patients were enrolled in this study. The median age of the 29 patients was 63.0 years (range, 35.0-83.0 years). Majority of patients were female (17/29, 58.6%), had stage II-IV disease (23/29, 79.3%), had an International Prognostic Index (IPI) score of 0-2 (20/29, 69.0%), and had an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 (21/29, 72.4%). Sixteen patients (55.2%) completed 6 cycles of treatment, and 22 patients (75.9%) completed 4-6 cycles of treatment. Of the 29 patients, 19 (65.5%) achieved a complete response, 5 (17.2%) achieved a partial response, 1 (3.5%) had a stable disease, and 4 unknown (13.8%). The ORR and DCR were 82.8% (95% CI, 64.2-94.2%) and 86.2% (95% CI, 68.3-96.1%), respectively. Hematological and non-hematological adverse events were reported in 75.9% and 17.2% of patients, respectively.