RESUMO
We conducted a phase II study to assess activity and safety profile of bendamustine and rituximab in elderly patients with untreated diffuse large B-cell lymphoma (DLBCL) who were prospectively defined as frail using a simplified version of the Comprehensive Geriatric Assessment (CGA). Patients had to be over 70 years of age, with histologically confirmed DLBCL. Frail patients were those younger than 80 years with a frail profile at CGA or older than 80 years with an unfit profile. Treatment consisted of 4-6 courses of bendamustine [90 mg/m2 days (d)1-2] and rituximab (375 mg/m2 d1) administered every 28 days. Other main study end points were complete remission rate and the rate of extra-hematologic adverse events. Forty-nine patients were enrolled of whom 45 were confirmed eligible. Overall, 24 patients achieved a complete remission (53%; 95%CI: 38-68%) and the overall response rate was 62% (95%CI: 47-76%). The most frequent grade 3-4 adverse event was neutropenia (37.8%). Grade 3-4 extra-hematologic adverse events were observed in 7 patients (15.6%; 95%CI: 6.5-29.5%); the most frequent was grade 3 infection in 2 patients. With a median follow up of 33 months (range 1-52), the median progression-free survival was ten months (95%CI: 7-25). The study shows promising activity and manageable toxicity profile of BR combination as first-line therapy for patients with DLBCL who are prospectively defined as frail according to a simplified CGA, as adopted in this trial (clinicaltrials.gov identifier: 01990144).
Assuntos
Cloridrato de Bendamustina/administração & dosagem , Idoso Fragilizado , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Rituximab/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimioterapia de Consolidação/métodos , Feminino , Humanos , Infecções/induzido quimicamente , Itália , Linfoma Difuso de Grandes Células B/mortalidade , Masculino , Neutropenia/induzido quimicamente , Indução de Remissão/métodos , Análise de Sobrevida , Resultado do TratamentoAssuntos
Leucemia Mieloide Aguda , Síndromes Mielodisplásicas , Neoplasias Ovarianas , Feminino , Humanos , Leucemia Mieloide Aguda/genética , Mutação , Síndromes Mielodisplásicas/genética , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/genética , Neoplasias Ovarianas/patologia , Inibidores de Poli(ADP-Ribose) Polimerases/farmacologia , Inibidores de Poli(ADP-Ribose) Polimerases/uso terapêuticoAssuntos
Anfotericina B/administração & dosagem , Antifúngicos/administração & dosagem , Doenças Hematológicas/tratamento farmacológico , Mucormicose/tratamento farmacológico , Sistema de Registros , Triazóis/administração & dosagem , Quimioterapia Combinada , Seguimentos , Doenças Hematológicas/epidemiologia , Humanos , Mucormicose/epidemiologia , Resultado do TratamentoRESUMO
Patients who underwent autologous stem cell transplantation (ASCT) are prone to decreased bone mineral density (BMD). We measured BMD in 180 patients who underwent ASCT for hematologic malignancies. Patients were evaluated with a median of 6.2 years after ASCT. Twenty patients who received only chemotherapy were evaluated as controls. The loss of bone mass was greater during the first year after ASCT, since majority of patients recover BMD and normalize bone turnover markers during the following years. After ASCT, over half of the patients show osteopenia or osteoporosis independent of the sex. According to the results of other groups, our results emphasize the potential usefulness of antiresorptive agents to prevent or treat post-ASCT osteopenia or osteoporosis, and the importance of the measurement of BMD as an integral component to the follow-up of ASCT.