[Randomized controlled study of leucomax (recombinant human granulocyte-macrophage colony stimulating factor, rhGM-CSF) in the treatment of cancer chemotherapy-induced leucopenia].
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.


CONCLUSIONS
Leucomax is a valuable adjunct in cancer chemotherapy.
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing.
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F
Feng
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Zhou
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced / Q000188:drug therapy*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008223:Lymphoma / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor