title: A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer.
abstract: We conducted a randomized phase II trial of two different schedules of topotecan in patients with advanced-stage non small lung cancer (NSCLC) without prior cytotoxic chemotherapy. All patients had histologic or cytologic confirmation of stage IV (M1) or III-B NSCLC. Patients were stratified by performance status, stage and weight loss. Patients were randomized to receive topotecan at intravenous doses of 1.5 mg/m(2)/day over 30 min for 5 days every 3 weeks (Arm A) or 1.3 mg/m(2)grade 3 in both arms included leukopenia, thrombocytopenia, malaise, constipation, diarrhea, lethargy, pulmonary, vomiting, infection and myalgia. Severe (> or = grade 3) thrombocytopenia occurred in 15.8% of Arm A patients and 37.8% of Arm B patients and this difference was statistically significant (P=0.03). The median times to progression are 101 and 63 days (P=0. 75) and the median survival times are 257 and 179 days (P=0.83) for Arms A and B, respectively. These differences in time to progression and overall survival are not statistically significant. Topotecan has limited, single agent activity in advanced NSCLC when given as 1. 5 mg/m(2)/day over 30 min for 5 days every 3 weeks. We do not intend to pursue further investigations with topotecan in patients with NSCLC.
authors.affiliation: CentraCare Clinic, St. Cloud, 56301, MN, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Weitz
authors.forename: R F
authors.initials: RF
authors.lastname: Marschke
authors.forename: J A
authors.initials: JA
authors.lastname: Sloan
authors.forename: J P
authors.initials: JP
authors.lastname: Grill
authors.forename: J R
authors.initials: JR
authors.lastname: Jett
authors.forename: J A
authors.initials: JA
authors.lastname: Knost
authors.forename: A K
authors.initials: AK
authors.lastname: Hatfield
authors.forename: D W
authors.initials: DW
authors.lastname: Zenk
authors.forename: W W
authors.initials: WW
authors.lastname: Bate
authors.forename: P L
authors.initials: PL
authors.lastname: Schaefer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D019772:Topotecan / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan