title: Lenograstim as support for ACE chemotherapy of small-cell lung cancer: a phase III, multicenter, randomized study.
abstract: This phase III study was conducted to evaluate the usefulness of lenograstim as support for ACE (doxorubicin, cyclophosphamide, and etoposide) chemotherapy in previously untreated patients with small-cell lung cancer. Patients were randomized to receive up to six 3-week cycles of either ACE alone (n = 139) or ACE with lenograstim support (150 microg/m2/day subcutaneously, days 4-13, n = 141). Compared with the chemotherapy-alone group, the lenograstim support group was more likely to achieve neutrophil recovery (absolute neutrophil count, > or =1.5 x 10(9) cells/l) by day 14 (95.8-100% vs. 14.3-24.1% across the cycles) and less likely to experience at least one infectious episode (36.7 vs. 54.0%; p = 0.004), chemotherapy delay (51.8 vs. 56.2%; NS), or dose reduction (17.3 vs. 27.7%; p = 0.037). Objective response and event-free and overall survival rates were similar. Lenograstim was well tolerated. Lenograstim may allow the interval between cycles of ACE to be reduced to 2 weeks; such dose intensification may lead to more favorable objective response and survival rates.
authors.affiliation: Krankenhaus Grosshansdorf, Pneumology/Oncology, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Gatzemeier
authors.forename: J P
authors.initials: JP
authors.lastname: Kleisbauer
authors.forename: P
authors.initials: P
authors.lastname: Drings
authors.forename: E
authors.initials: E
authors.lastname: Kaukel
authors.forename: N
authors.initials: N
authors.lastname: Samaras
authors.forename: M J
authors.initials: MJ
authors.lastname: Melo
authors.forename: F
authors.initials: F
authors.lastname: Cardenal
authors.forename: G
authors.initials: G
authors.lastname: Robinet
authors.forename: R J
authors.initials: RJ
authors.lastname: Snijder
authors.forename: J
authors.initials: J
authors.lastname: von Pawel
authors.forename: R
authors.initials: R
authors.lastname: Palisses
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D000078224:Lenograstim; D007958:Leukocyte Count / Q000187:drug effects; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000187:drug effects; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D000972:Antineoplastic Agents, Phytogenic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D000078224:Lenograstim; D004317:Doxorubicin; D003520:Cyclophosphamide