Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report.

The purpose of this report is to analyze long-term clinical outcomes of patients exposed to plerixafor plus granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization. This was a study of patients with non-Hodgkin lymphoma (NHL; n = 167) and multiple myeloma (MM; n = 163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240 µg/kg plerixafor plus 10 µg/kg G-CSF, or placebo plus 10 µg/kg G-CSF to mobilize and collect CD34+ cells for autologous hematopoietic stem cell transplantation. Overall survival (OS) and progression-free survival (PFS) were evaluated over a 5-year period following the first dose of plerixafor or placebo. The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively). In addition, there was no statistically significant difference in the probability of PFS over 5 years between treatment groups in patients with NHL (50%; 95% CI, 44% to 67% for plerixafor versus 43%; 95% CI, 31% to 54% for placebo) or those with MM (17%; 95% CI, 10% to 24% for plerixafor versus 30%; 95% CI, 21% to 40% for placebo). In this long-term follow-up study, the addition of plerixafor to G-CSF for stem cell mobilization did not affect 5-year survival in patients with NHL or patients with MM.

A phase IV, randomized, multicenter, open-label trial comparing efficacy and systemic exposure for a standard weight-based dose versus a fixed dose of plerixafor in combination with G-CSF in patients with Non-Hodgkin's lymphoma weighing ≤70 kg.

A randomized, multicenter, open-label study explored the effect of a fixed-dose (FD) of plerixafor versus the approved weight-based (WB) dose for the mobilization of hematopoietic stem cells (HSCs) in patients with non-Hodgkin's lymphoma and a body weight of ≤70 kg. After mobilization with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, patients were randomized 1:1 to either plerixafor FD 20 mg (n = 30) or WB 0.24 mg/kg (n = 31) on the evening of Day 4. Co-primary endpoints were the proportion of patients achieving ≥5 × 106 CD34+ cells/kg in ≤4 days of apheresis, and total systemic exposure to plerixafor (area under the concentration-time curve from 0 to 10 h [AUC0-10]). There was no statistically significant difference between the proportion of patients attaining the primary efficacy endpoint (60% FD arm, 55% WB arm; P = 0.395). Exposure to plerixafor was greater in the FD arm relative to the WB arm; however, there was no appreciable difference regarding fold increases of peripheral blood CD34+ cells. The safety profile was similar between treatment groups. These results suggest there is no statistically significant difference in HSC mobilization with a standard WB dosing regimen of plerixafor plus G-CSF in patients with low body weight compared with an FD regimen.

Assistência circulatória com aparelho Heart Mate na Cleveland Clinic Foundation: experiência inicial e futuras aplicaçöes / Circulatory assistance with Heart Mate appliance at the Cleveland Clinic Foundation: clinical experience and future uses

Estudar a experiência inicial em assistência circulatória ventricular esquerda com o aparelho pneumático implantável Heart Mate( 1000 IP, analisando suas características e aplicaçöes clínicas. Material e Métodos: Entre dez/91 e Set/94 (45 meses) 33 pacientes em choque cardiogênico por miocardiopatia isquêmica ou dilatada foram assistidos, com esse aparelho, por um tempo de 0 a 153 dias (média de 76 dias, nos pacientes que chegaram a ser transplantados). O diagnóstico, o tempo de assistência circulatória, os parâmetros hemodinâmicos (índice cardíaco, gradiente transpulmonar, fraçäo de ejeçäo do ventrículo direito, resistência vascular pulmonar e variaçäo da área do ventrículo direito), assim como as complicaçöes clínicas säo apresentados e discutidos. Valores pré e pós implante säo apresentados como média +/- desvio padräo e comparados por teste T pareado. Resultados: A melhora hemodinâmica foi estatisticamente significante (p<0,05). Houve 9 (27,3 por cento) óbitos, pelas seguintes complicaçöes: sepse, falência de VD e insuficiência respiratória. Vinte e quatro pacientes foram transplantados. Näo houve nenhum caso de tromboembolismo. Conclusöes: Houve melhora clínica em pacientes com elevado risco para transplante cardíaco de urgência, com relativamente baixa taxa de morbi-mortalidade durante a assitência e alta taxa de transplantes (69,7 por cento). Os resultados encorajam o uso desse aparelho para tratamento da fase final da insuficiência cardíaca congestiva grave.