RESUMO
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.
Assuntos
Sobrevivência de Enxerto/efeitos dos fármacos , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Mobilização de Células-Tronco Hematopoéticas/métodos , Linfoma/terapia , Transplante de Células-Tronco de Sangue Periférico , Fator de Células-Tronco/análogos & derivados , Condicionamento Pré-Transplante/métodos , Adulto , Idoso , Antígenos CD34/sangue , Quimioterapia Combinada/efeitos adversos , Feminino , Filgrastim , Fator Estimulador de Colônias de Granulócitos/efeitos adversos , Mobilização de Células-Tronco Hematopoéticas/efeitos adversos , Humanos , Linfoma/sangue , Masculino , Pessoa de Meia-Idade , Neutropenia/induzido quimicamente , Neutropenia/prevenção & controle , Transplante de Células-Tronco de Sangue Periférico/efeitos adversos , Projetos Piloto , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Fator de Células-Tronco/efeitos adversos , Fator de Células-Tronco/uso terapêutico , Trombocitopenia/induzido quimicamente , Trombocitopenia/prevenção & controle , Condicionamento Pré-Transplante/efeitos adversos , Transplante Autólogo/efeitos adversos , Adulto JovemRESUMO
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.
