Clinical benefits of lenograstim in patients with neutropenia due to chemotherapy for multiple myeloma (MM).
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.
Takagi
T
T
Chiba Cancer Center Hospital, Chiba City, Japan. ttakagi@chiba-cc.pref.chiba.jp
Sawamura
M
M
Sezaki
T
T
Kashimura
M
M
Tsuchiya
J
J
Hotta
T
T
Ogawa
N
N
Hirashima
K
K
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
D000276:Adjuvants, Immunologic; D009607:Nitrosourea Compounds; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D011239:Prednisolone; D008558:Melphalan; D014751:Vindesine