Bendamustine is an alkylating agent with favorable clinical activity against indolent lymphomas as single-agent or combined with rituximab. Up to now, data on clinical efficacy of bendamustine in aggressive non Hodgkin lymphomas (NHL) are extremely limited. More than one third of the elderly patients are not fit to receive front-line high-dose chemotherapy for a newly diagnosed aggressive B cell lymphoma due to pre-existing comorbidities, and outcome for these elderly and frail patients not eligible for rituximab, cyclophosphamide, doxorubicin, vincristin and prednisone (R-CHOP) standard treatment is poor with a median survival of less than 6 months. Therefore, for these “slow go” patients with aggressive NHL, alternative effective treatments with less toxicity are required. From January 2012 up to now, we evaluated efficacy and safety of bendamustine plus rituximab (R-B; R at a dose of 375 mg/m2 i.v. on day 1, and B at a dose of 90 mg/m2 on days 1 and 2 of each cycle, every 4 weeks), as frontline treatment in 13 (7 males and 6 females) elderly and frail consecutive patients with aggressive B-NHL (3 mantle cell lymphomas, 2 anaplastic and 8 diffuse large B-cell lymphomas) not eligible for R-CHOP. All patients gave their written informed consent. The median age of patients was 80 years (range, 71-87), and the median Karnofsky performance status was 65% (range, 40-90%). Three patients had stage II and 10 patients had stage III/IV disease. Response (complete remission -CR-, partial remission -PR- and progressive disease -PD-) was assessed according to revised international workshop response criteria. Up to now, a total of 40 cycles of R-B were administered, with a median of three cycles (range, 2–6 cycles) per patient. No patient discontinued or delayed treatment due to treatment-related toxicity. Grade III hematologic toxicity (mainly anemia) was documented in 2/13 (23%) patients, and only 1 patient needed 50% dose reduction of bendamustine. No organ toxicity >grade I was detected. Overall, 8 of the 13 patients were assessable for response. The overall response rate was 62%. Of these 8 patients, 4 achieved CR, 1 PR and 3 showed PD. Two of these 13 patients died for PD. Our preliminary data provide evidence that R-B is an effective and well tolerated frontline therapy in elderly and frail aggressive B-NHL patients. These results require further validation in prospective randomized studies.

Bendamustine in combination with rituximab for elderly patients with aggressive B non hodgkin lymphoma not eligible for anthracycline-based therapy

SELLERI, Carmine
2013

Abstract

Bendamustine is an alkylating agent with favorable clinical activity against indolent lymphomas as single-agent or combined with rituximab. Up to now, data on clinical efficacy of bendamustine in aggressive non Hodgkin lymphomas (NHL) are extremely limited. More than one third of the elderly patients are not fit to receive front-line high-dose chemotherapy for a newly diagnosed aggressive B cell lymphoma due to pre-existing comorbidities, and outcome for these elderly and frail patients not eligible for rituximab, cyclophosphamide, doxorubicin, vincristin and prednisone (R-CHOP) standard treatment is poor with a median survival of less than 6 months. Therefore, for these “slow go” patients with aggressive NHL, alternative effective treatments with less toxicity are required. From January 2012 up to now, we evaluated efficacy and safety of bendamustine plus rituximab (R-B; R at a dose of 375 mg/m2 i.v. on day 1, and B at a dose of 90 mg/m2 on days 1 and 2 of each cycle, every 4 weeks), as frontline treatment in 13 (7 males and 6 females) elderly and frail consecutive patients with aggressive B-NHL (3 mantle cell lymphomas, 2 anaplastic and 8 diffuse large B-cell lymphomas) not eligible for R-CHOP. All patients gave their written informed consent. The median age of patients was 80 years (range, 71-87), and the median Karnofsky performance status was 65% (range, 40-90%). Three patients had stage II and 10 patients had stage III/IV disease. Response (complete remission -CR-, partial remission -PR- and progressive disease -PD-) was assessed according to revised international workshop response criteria. Up to now, a total of 40 cycles of R-B were administered, with a median of three cycles (range, 2–6 cycles) per patient. No patient discontinued or delayed treatment due to treatment-related toxicity. Grade III hematologic toxicity (mainly anemia) was documented in 2/13 (23%) patients, and only 1 patient needed 50% dose reduction of bendamustine. No organ toxicity >grade I was detected. Overall, 8 of the 13 patients were assessable for response. The overall response rate was 62%. Of these 8 patients, 4 achieved CR, 1 PR and 3 showed PD. Two of these 13 patients died for PD. Our preliminary data provide evidence that R-B is an effective and well tolerated frontline therapy in elderly and frail aggressive B-NHL patients. These results require further validation in prospective randomized studies.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11386/4241253
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