title: Clinical benefits of lenograstim in patients with neutropenia due to chemotherapy for multiple myeloma (MM).
abstract: The object of this study was to determine the efficacy and safety of glycosylated recombinant human granulocyte colony-stimulating factor (rHuG-CSF; lenograstim) after combination chemotherapy consisting of ranimustine, vindesine, melphalan and prednisolone (MCNU-VMP). One hundred thirty-nine consecutive patients with newly diagnosed multiple myeloma (MM) were allocated at random to a lenograstim group (n = 70) or a placebo group (n = 69). Patients were treated with two cycles of MCNU-VMP, and either lenograstim (2 microg/kg daily, s.c.) or placebo was administered from the day neutrophils decreased to less than 1.000/microl and was discontinued when neutrophils exceeded 5,000/microl. The median duration of neutropenia (neutrophils under 1,000/microl) was significantly shorter for the lenograstim group than the placebo group (2 days vs 9 days in the first cycle; 1 day vs 13 days in the second cycle). The incidence of febrile neutropenia in the first cycle was significantly lower in the lenograstim group than in the placebo group (9.2% vs 30.4%). No life-threatening infections were observed in either group. The two cycles of MCNU-VMP therapy were completed in 90.8% of the patients, and a higher average relative dose intensity (ARDI; 0.94) was achieved in the lenograstim group. The tumor response rate of the lenograstim group (57.8%) was higher than that of the placebo group (43.1%), but the difference was not statistically significant (chi2 = 2.634, df = 1, P = 0.105). Lenograstim was well tolerated, and no unexpected adverse events occurred. Lenograstim proved effective in controlling chemotherapy-induced neutropenia in MM patients under MCNU-VMP therapy.
authors.affiliation: Chiba Cancer Center Hospital, Chiba City, Japan. ttakagi@chiba-cc.pref.chiba.jp
authors.forename: T
authors.initials: T
authors.lastname: Takagi
authors.forename: M
authors.initials: M
authors.lastname: Sawamura
authors.forename: T
authors.initials: T
authors.lastname: Sezaki
authors.forename: M
authors.initials: M
authors.lastname: Kashimura
authors.forename: J
authors.initials: J
authors.lastname: Tsuchiya
authors.forename: T
authors.initials: T
authors.lastname: Hotta
authors.forename: N
authors.initials: N
authors.lastname: Ogawa
authors.forename: K
authors.initials: K
authors.lastname: Hirashima
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D000078224:Lenograstim; D008297:Male; D008558:Melphalan / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D009607:Nitrosourea Compounds / Q000009:adverse effects; D011239:Prednisolone / Q000009:adverse effects; D011994:Recombinant Proteins / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014751:Vindesine / Q000009:adverse effects
chemical_list: D000276:Adjuvants, Immunologic; D009607:Nitrosourea Compounds; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D011239:Prednisolone; D008558:Melphalan; D014751:Vindesine