TY - JOUR
T1 - Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma
T2 - Results from a phase II multicenter, single-agent study
AU - Friedberg, Jonathan W.
AU - Cohen, Philip
AU - Chen, Ling
AU - Robinson, K. Sue
AU - Forero-Torres, Andres
AU - La Casce, Ann S.
AU - Fayad, Luis E.
AU - Bessudo, Alberto
AU - Camacho, Elber S.
AU - Williams, Michael E.
AU - Van Der Jagt, Richard H.
AU - Oliver, Jennifer W.
AU - Cheson, Bruce D.
PY - 2008/1/10
Y1 - 2008/1/10
N2 - Purpose: Bendamustine hydrochloride is an alkylating agent with novel mechanisms of action. This phase II multicenter study evaluated the efficacy and toxicity of bendamustine in patients with B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab. Patients and Methods: Patients received bendamustine 120 mg/m2 intravenously on days 1 and 2 of each 21-day cycle. Outcomes included response, duration of response, progression-free survival, and safety. Results: Seventy-six patients, ages 38 to 84 years, with predominantly stage III/IV indolent (80%) or transformed (20%) disease were treated; 74 were assessable for response. Twenty-four (32%) were refractory to chemotherapy. Patients received a median of two prior unique regimens. An overall response rate of 77% (15% complete response, 19% unconfirmed complete response, and 43% partial) was observed. The median duration of response was 6.7 months (95% CI, 5.1 to 9.9 months), 9.0 months (95% CI, 5.8 to 16.7) for patients with indolent disease, and 2.3 months (95% CI, 1.7 to 5.1) for those with transformed disease. Thirty-six percent of these responses exceeded 1 year. The most frequent nonhematologic adverse events included nausea and vomiting, fatigue, constipation, anorexia, fever, cough, and diarrhea. Grade 3 or 4 reversible hematologic toxicities included neutropenia (54%), thrombocytopenia (25%), and anemia (12%). Conclusion: Single-agent bendamustine produced durable objective responses with acceptable toxicity in heavily pretreated patients with rituximab-refractory, indolent NHL. These findings are promising and will serve as a benchmark for future clinical trials in this novel patient population.
AB - Purpose: Bendamustine hydrochloride is an alkylating agent with novel mechanisms of action. This phase II multicenter study evaluated the efficacy and toxicity of bendamustine in patients with B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab. Patients and Methods: Patients received bendamustine 120 mg/m2 intravenously on days 1 and 2 of each 21-day cycle. Outcomes included response, duration of response, progression-free survival, and safety. Results: Seventy-six patients, ages 38 to 84 years, with predominantly stage III/IV indolent (80%) or transformed (20%) disease were treated; 74 were assessable for response. Twenty-four (32%) were refractory to chemotherapy. Patients received a median of two prior unique regimens. An overall response rate of 77% (15% complete response, 19% unconfirmed complete response, and 43% partial) was observed. The median duration of response was 6.7 months (95% CI, 5.1 to 9.9 months), 9.0 months (95% CI, 5.8 to 16.7) for patients with indolent disease, and 2.3 months (95% CI, 1.7 to 5.1) for those with transformed disease. Thirty-six percent of these responses exceeded 1 year. The most frequent nonhematologic adverse events included nausea and vomiting, fatigue, constipation, anorexia, fever, cough, and diarrhea. Grade 3 or 4 reversible hematologic toxicities included neutropenia (54%), thrombocytopenia (25%), and anemia (12%). Conclusion: Single-agent bendamustine produced durable objective responses with acceptable toxicity in heavily pretreated patients with rituximab-refractory, indolent NHL. These findings are promising and will serve as a benchmark for future clinical trials in this novel patient population.
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U2 - 10.1200/JCO.2007.12.5070
DO - 10.1200/JCO.2007.12.5070
M3 - Article
C2 - 18182663
AN - SCOPUS:38349119981
SN - 0732-183X
VL - 26
SP - 204
EP - 210
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 2
ER -