Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment.

SCF has been shown to synergize with G-CSF to mobilize CD34(+) PBPCs. In this study we report results from this combination after a phase II trial of 32 patients with malignant lymphoma randomized to receive recombinant methionyl human SCF (ancestim, r-metHuSCF) in combination with recombinant methionyl human G-CSF (filgrastim, r-metHuG-CSF) (experimental arm A) or routine chemotherapy plus filgrastim (conventional arm B). The primary objective was to evaluate the side effects and toxicity during priming and mobilization. The secondary objectives were efficacy by the level of blood-circulating PBPCs, the number of harvest days and the time to three-lineage engraftment after autografting. First, during priming 5 patients had 8 serious events, 4 in each arm. A summary of all adverse events revealed 30 (94%) patients suffering from 132 events of all grading. Second, neutropenia and thrombocytopenia was documented in arm B. Third, 9/14 (64%) patients in arm A reached the target of 5 million CD34(+) cells/kg body weight (bw) compared with 13/15 (87%) in arm B. The results represent the first randomized trial of growth factor plus chemotherapy priming and indicate that a formal phase III trial very unlikely may challenge chemotherapy plus r-metHuG-CSF priming in candidates for high-dose therapy.

Should blood flow during cardiopulmonary bypass be individualized more than to body surface area?

Blood flow during cardiopulmonary bypass (CPB) is calculated on body surface area (BSA). Increasing comorbidity, age and weight of today's cardiac patients question this calculation as it may not reflect individual metabolic requirement. The hypothesis was that a measured cardiac index (CI) prior to normothermic CPB is a better estimate. A cross-over study, with random allocation to CPB blood flow for 20 minutes based on either a calculation (2.4 L/min/m(2)) or on CI, with a switch to the opposite flow for another 20 minutes, was performed. Twenty-two elective cardiac surgery patients with normal ventricular function were included. Effect parameters were cerebral oxygenation, mixed venous saturation and arterial lactate. CI varied from 1.9 to 3.1 L/min/m(2) (median 2.4 L/min/m(2)). No differences in effect parameters were seen. In conclusion, a CPB blood flow based on an individual estimate did not improve cerebral and systemic oxygenation compared to a blood flow based on BSA.