RESUMO
Despite the long history of bendamustine as treatment for indolent non-Hodgkin lymphoma, long-term efficacy and toxicity data are minimal. We reviewed long-term data from three clinical trials to characterize the toxicity and efficacy of patients receiving bendamustine. Data were available for 149 subjects at 21 sites. The median age was 60 years at the start of bendamustine (range 39-84), and patients had received a median of 3 prior therapies. The histologies included grades 1-2 follicular lymphoma (FL; n = 73), grade 3 FL (n = 23), small lymphocytic lymphoma (n = 20), marginal zone lymphoma (n = 15), mantle cell lymphoma (n = 9), transformed lymphomas (n = 5), lymphoplasmacytic lymphoma (n = 2) and not reported (n = 2). The median event-free survival was 14·1 months. Nine of 12 attempted stem cell collections were successful. With a median follow-up of 8·9 years, 23 patients developed 25 cancers, including 8 patients with myelodysplastic syndrome/acute myeloid leukaemia. These data provide important information regarding the long-term toxicity of bendamustine in previously treated patients. A small but meaningful number of patients achieved durable remissions following bendamustine. These rigorously collected, patient-level, long-term follow-up data provide reassurance that bendamustine or bendamustine plus rituximab is associated with efficacy and safety for patients with relapsed or refractory indolent non-Hodgkin lymphoma.
Assuntos
Antineoplásicos Alquilantes/administração & dosagem , Cloridrato de Bendamustina/administração & dosagem , Mobilização de Células-Tronco Hematopoéticas/métodos , Linfoma não Hodgkin/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Alquilantes/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cloridrato de Bendamustina/efeitos adversos , Ensaios Clínicos como Assunto , Intervalo Livre de Doença , Feminino , Humanos , Leucemia Mieloide Aguda/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Síndromes Mielodisplásicas/induzido quimicamente , Segunda Neoplasia Primária/induzido quimicamente , Rituximab/administração & dosagem , Rituximab/efeitos adversos , Fatores de Tempo , Resultado do TratamentoAssuntos
Doença de Hodgkin/radioterapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Combinada , Intervalo Livre de Doença , Medicina Baseada em Evidências , Feminino , Fluordesoxiglucose F18 , Doença de Hodgkin/diagnóstico , Doença de Hodgkin/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons , Compostos Radiofarmacêuticos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Adulto JovemRESUMO
OBJECTIVES: Of the several barriers associated with uptake and adherence to hearing services, cost is the most commonly identified barrier in Canada. This study evaluated health insurance plans for hearing care coverage within Alberta, Canada, and subsequent out-of-pocket expenses that would result if an individual chose to pursue treatment. METHODS: An investigation of eight companies that provide supplementary health coverage in Alberta was conducted. Categories of health service coverage included hearing, vision, speech-language pathology (S-LP), physical therapy related (PT-R; including massage therapy and chiropractic therapy) and alternative medicine related (AM-R; including osteopathy, acupuncture and naturopathy). All coverage amounts were corrected to a four-year term for comparison purposes. RESULTS: For a four-year term, the coverage amounts for hearing services were CAD 300-750; for vision services were CAD 0-900; for S-LP services were CAD 0-2,400; for PT-R services were CAD 1,400-10,200; and for AM-R services were CAD 0-10,200 per four-year term. The expected out-of-pocket expense for vision ranged from CAD 0 to CAD 2,766, whereas for hearing, it ranged from CAD 250 to CAD 11,700. CONCLUSION: A considerable range and discrepancy were reported between hearing care and most paramedical services. In addition, the coverage amounts for hearing care were inconsistent with treatment costs, resulting in considerable out-of-pocket expenses for most consumers. The potential implications of such cost-related barriers on public health are an important consideration as our understanding of the impact of untreated hearing impairment continues to increase.
Assuntos
Óculos/economia , Óculos/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Auxiliares de Audição/economia , Auxiliares de Audição/provisão & distribuição , Cobertura do Seguro/economia , Cobertura do Seguro/estatística & dados numéricos , Adolescente , Adulto , Alberta , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
A systematic review and meta-analysis was performed to determine the efficacy and toxicity of thalidomide in previously untreated patients with myeloma. Medline, Embase, Cochrane Controlled Trials Register, and abstracts from the American Society of Hematology and the American Society of Clinical Oncology were searched for randomized controlled trials (RCTs) of either induction or maintenance thalidomide in adults with previously untreated myeloma. Nine RCTs of induction thalidomide, three RCTs of maintenance thalidomide, and one RCT of induction and maintenance thalidomide were identified, involving a total of 4144 subjects. When thalidomide was added to standard, non-transplantation myeloma therapy, overall survival (OS) improved (HR 0.67; 95% CI 0.56-0.81). When thalidomide was given as maintenance following autologous transplantation (ASCT), there was a trend to improved OS (HR 0.61, 95% CI 0.37-1.01); when the only trial which combined induction and maintenance thalidomide was excluded from this analysis, a significant survival advantage emerged (HR 0.49, 95% CI 0.32-0.74). The relative risk of venous thromboembolism (VTE) with induction thalidomide was 2.56 (95% CI 1.88-3.49). A meta-analysis of trials/sub-groups administering low molecular weight heparin (LMWH) as VTE prophylaxis, suggested a persistently increased relative risk of VTE with induction thalidomide (RR 1.54, 95% CI 1.07-2.22). The relative risk of VTE was substantially lower, but still elevated, when thalidomide was given as maintenance therapy following ASCT (RR 1.95, 95% CI 1.15-3.30). In summary, thalidomide appears to improve the overall survival of patients with newly diagnosed myeloma both when it is added to standard, non-transplantation therapy, and when it is given as maintenance therapy following ASCT. However, thalidomide is associated with toxicity, particularly a significantly increased risk of VTE.
Assuntos
Imunossupressores/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Talidomida/uso terapêutico , Progressão da Doença , Humanos , Mieloma Múltiplo/patologia , Resultado do TratamentoRESUMO
PURPOSE: Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab. PATIENTS AND METHODS: Patients received rituximab 375 mg/m(2) intravenously on day 1 and bendamustine 90 mg/m(2) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs. RESULTS: Overall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%). CONCLUSION: Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.