[Randomisierte kontrollierte Studie von leucomax (rekombinantes humanes Granulozyten-Makrophagen-Kolonie-stimulierender Faktor, rhGM-CSF) zur Behandlung von Krebs-Chemotherapie-induzierter Leukopenie].

OBJECTIVE: To evaluate leucomax (rhGM-CSF) in prevention and treatment of leucopenia and neutropenia induced by chemotherapy in cancer patients. METHODS: A multicenter, randomized, matched and cross-over clinical trial of the effect of leucomax on leucopenia and neutropenia induced by combination chemotherapy in cancer patients was conducted. Fifty seven enrolled patients were randomized into AB group and BA group. Each patient received two cycles of treatment. In group AB, combination chemotherapy and leucomax were used in the first cycle and combination chemotherapy alone was used in the second cycle, while vice versa in group BA. In 2 patients, the study was stopped due to leucomax adverse reactions. Fifty five patients were eligible for analysis of clinical efficacy. RESULTS: Leucomax significantly increased the number of total white blood cell count and absolute neutrophil count at the nadir, decreased the incidence of leucopenia and neutropenia and shortened the time period of leucopenia and neutropenia induced by chemotherapy. Leucomax also resulted in quicker recovery of leucopenia and neutropenia. Leucomax ensured the scheduled chemotherapy. The main adverse reactions with mild to moderate fever, pain at the injection site, bone pain, myalgia, asthenia and skin rash were generally tolerable. CONCLUSION: Leucomax is a valuable adjunct in cancer chemotherapy.