A prospective, randomized, sequential, crossover trial of large-volume versus normal-volume leukapheresis procedures: effect on progenitor cells and engraftment

BACKGROUND: The influence of leukapheresis size on the number of harvested peripheral blood progenitor cells is still unclear. A prospective randomize d crossover trial was thus performed, to evaluate the effect of large-volum e leukapheresis (LVL) versus normal-volume leukapheresis (NVL) on progenito r cells and engraftment in 26 patients with breast cancer and 15 patients w ith non-Hodgkin's lymphoma who were eligible for peripheral blood progenito r cell transplantation. STUDY DESIGN AND METHODS: Patients were randomly assigned to undergo either LVL on Day 1 and on Day 2 or vice versa. The number of progenitor cells wa s evaluated in the harvest and before and after leukapheresis in the periph eral blood. RESULTS: The number of harvested CD34+ cells (4.8 x 10(6) vs. 3.4 x 10(6)/k g body weight. p<0.001) and colony-forming units-granulocyte-macrophage (3. 1 x 10(5) vs. 2.4 x 10(5)/kg body weight, p = 0.0026) was significantly hig her for LVL procedures than for NVL procedures. The median extraction effic acy, defined as the difference between the yield in the harvest and the dec rease in the total number of CD34+ cells in peripheral blood during leukaph eresis, was significantly (p<0.0001) higher for LVL than for NVL (2.6 x 10( 8) and 8 x 10(7), respectively). In patients with breast cancer, the median amount of CD34+ cells in the harvest and the median extraction efficacy we re higher for LVL than for NVL (p<0.0001). This was not found for patients with non-Hodgkin's lymphoma. CONCLUSION: LVL results in a higher yield of CD34+ cells and colony-forming units-granulocyte;macrophage than NVL, but only in patients with breast ca ncer and with high numbers of CD34+ cells in the peripheral blood before le ukapheresis.