ABSTRACT
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.
Subject(s)
Graft Survival/drug effects , Granulocyte Colony-Stimulating Factor/therapeutic use , Hematopoietic Stem Cell Mobilization/methods , Lymphoma/therapy , Peripheral Blood Stem Cell Transplantation , Stem Cell Factor/analogs & derivatives , Transplantation Conditioning/methods , Adult , Aged , Antigens, CD34/blood , Drug Therapy, Combination/adverse effects , Female , Filgrastim , Granulocyte Colony-Stimulating Factor/adverse effects , Hematopoietic Stem Cell Mobilization/adverse effects , Humans , Lymphoma/blood , Male , Middle Aged , Neutropenia/chemically induced , Neutropenia/prevention & control , Peripheral Blood Stem Cell Transplantation/adverse effects , Pilot Projects , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Stem Cell Factor/adverse effects , Stem Cell Factor/therapeutic use , Thrombocytopenia/chemically induced , Thrombocytopenia/prevention & control , Transplantation Conditioning/adverse effects , Transplantation, Autologous/adverse effects , Young AdultABSTRACT
Lycopodium clavatum (LC) spores were found in two cases in transrectal ultrasound-guided core biopsies of the prostate. The source turned out to be the coating of the condoms used for protection of the ultrasound probe. To minimize confusion in analyzing the biopsies and to avoid granulomas of the prostate, LC spore-free condoms are available and are recommended for the biopsy procedure.