ABSTRACT
Objective:To evaluate the efficacy and toxicity of single-agent bendamustine in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab. Methods:Between April 2010 and April 2013, 100 patients with rituximab-refrac-tory indolent B-cell NHL from 8 institutions were enrolled. Bendamustine was administered at 120 mg/m2 on days 1 and 2 every 21 days for 6-8 cycles. The primary endpoint was the overall response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results:One hundred patients with a median age of 56 (rang-ing from 28 to 74) years were recruited in this clinical study. The total number of chemotherapy was 447 cycles, and the median number was 4 cycles. Ninety-three patients could be evaluated for efficacy. Fifteen patients (16.1%) had complete remission (CR), 52 (55.9%) had partial remission (PR), 22 (23.7%) had stable disease (SD), and 4 (4.3%) had progression disease (PD). The ORR and DCR were 72%and 95.7%, respectively. After a median follow-up of 26.6 months (ranging from 2 to 48.4 months), 59 patients (63.4%) had PD.The median PFS was 8.53 (95%CI:6.518-10.542) months, and PFS rate for 1 year was (40.6±5.3)%. Forty-eight patients (48%) had 3/4 grade adverse events, including leucopenia (26%), neutropenia (24%), and anemia (11%). Conclusion:Single-agent bendamustine produced a high rate of objective responses in patients with rituximab-refractory indolent B-cell NHL and could be one of the new op-tions for second-line treatment of these patients. The most common adverse event is hematologic toxicity.
ABSTRACT
Objective:To observe the clinical efficacy and toxicities of bendamustine hydrochloride in patients with rituximab-re-fractory indolent B-cell non-Hodgkin's lymphoma (NHL). Methods:A total of 25 patients with rituximab-refractory NHL received bendamustine hydrochloride 120 mg/m2 intravenously on days 1 and 2 of the 21-day cycle. The short-term response, progression free survival, and toxicities were evaluated. Results:The total number of chemotherapy of the 25 patients was 122 cycles, and the median number was 5 cycles. All patients could be evaluated for efficacy. Among the patients, 6 had complete remission, 13 had partial remis-sion, 3 had stable disease, and 3 had progression disease. The overall response rate and clinical benefit rate were 76%and 88%, respec-tively. Until the deadline, 13 patients had progression disease. The median duration of response was 8 months, and the median progres-sion-free survival (PFS) was 9.3 months. Subgroup analysis showed that PFS is significantly related to bone marrow involvement and serum LDH level (P<0.05). The main adverse effects were myelosuppression, gastrointestinal reactions, and infection. Rash was found in 2 patients, and 1 case of gastric cancer was discovered after 5 cycles of treatment. Conclusion:Bendamustine hydrochloride was ef-fective and tolerable in patients with rituximab-refractory indolent B-cell NHL.