title: A randomized trial comparing imipenem/cilastatine alone with latamoxef plus tobramycin in febrile neutropenic patients with lung cancer.
abstract: We conducted a randomized trial to compare the efficacy of imipenem/cilastatine (IPM/CS) monotherapy with that of a combination of latamoxef (LMOX) and tobramycin (TOB) in the initial management of fever and neutropenia in patients with lung cancer. Leukocytopenic febrile patients (less than 3,000 leukocytes per microliters; temperature greater than 38 degrees C) with lung cancer given induction therapy were randomly assigned to receive intravenous treatment with either 1 g IPM/CS twice daily or 2 g LMOX plus 90 mg TOB twice daily. A total 101 febrile episodes were studied. Fifty-one episodes were treated with IPM/CS and 50 with LMOX+TOB. Fifty-nine of the febrile episodes were bacteriologically confirmed, while an organism could not be isolated despite the presence of obvious clinical infection in the remaining 42. The response rate was 82% with IPM/CS and 80% with combination therapy. This difference was not statistically significant. The response rate regarding gram-negative infections was 10 out of 14 (71%) in the IPM/CS group and seven out of 12 (58%) in the LMOX+TOB group. This difference was also not significant (P = 0.484). The response rate in severely neutropenic patients (neutrophils less than 100/microliters) was low (P = 0.078). Three patients in the IPM/CS group were withdrawn from the study due to skin rash and vomiting. Therapy with IPM/CS monotherapy was as effective as a combination regimen.
authors.affiliation: Department of Internal Medicine, Osaka Prefectural Habikino Hospital.
authors.forename: K
authors.initials: K
authors.lastname: Matsui
authors.forename: N
authors.initials: N
authors.lastname: Masuda
authors.forename: M
authors.initials: M
authors.lastname: Takada
authors.forename: Y
authors.initials: Y
authors.lastname: Kusunoki
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy*; D016009:Chi-Square Distribution; D015377:Cilastatin / Q000008:administration & dosage / Q000627:therapeutic use*; D000077728:Cilastatin, Imipenem Drug Combination; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy; D006801:Humans; D015378:Imipenem / Q000008:administration & dosage / Q000627:therapeutic use*; D016015:Logistic Models; D008175:Lung Neoplasms / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009070:Moxalactam / Q000627:therapeutic use*; D015999:Multivariate Analysis; D009503:Neutropenia / Q000188:drug therapy*; D011897:Random Allocation; D014031:Tobramycin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D015377:Cilastatin; D015378:Imipenem; D000077728:Cilastatin, Imipenem Drug Combination; D009070:Moxalactam; D014031:Tobramycin