title: Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy.
abstract: OBJECTIVE
  This study was designed to assess the anti-tumor activity of topotecan (TPT) in patients with advanced non-small-cell lung cancer (NSCLC) previously untreated with chemotherapy.
  
  
  METHODS
  Patients with stage IIIB or IV NSCLC with measurable disease in nonradiated fields were eligible. Other eligibility criteria were Zubrod performance status (PS) < or = 2 and adequate renal and liver function. TPT was administered at a dose of 1.5 mg/m2/d for 5 days over 30 minutes every 21 days. Of 48 registered patients, 40 were fully assessable. Nineteen patients had adenocarcinoma (AD), 14 squamous carcinoma (SCC), and seven poorly differentiated carcinoma.
  
  
  RESULTS
  Six patients (15%) achieved a partial remission (PR) (durations: 8, 14, 18, 28, 56, and 61 weeks) and four patients a minor response; 10 patients had stable disease and 20 patients progressive disease. The PR rate was 36% (five of 14 patients) in patients with SCC versus 4% (one of 26 patients) in those with other histologies (P = .014). The overall median survival time was 38 weeks and 30% of patients were alive at 1 year. Grade 3 to 4 granulocytopenia and thrombocytopenia occurred after 76% and 10% of courses administered, respectively. No grade 3 to 4 nonhematologic toxicities were observed. Grade 1 or 2 nonhematologic toxicities consisted of nausea (46% and 5%), vomiting (31% and 7%), and fatigue (53% and 16%).
  
  
  CONCLUSIONS
  TPT at the dose and schedule used has moderate antitumor activity in NSCLC; its activity is mostly limited to patients with SCC. TPT is well tolerated, with myelosuppression of short duration being the most common and limiting toxicity.
authors.affiliation: Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, USA.
authors.forename: R
authors.initials: R
authors.lastname: Perez-Soler
authors.forename: F V
authors.initials: FV
authors.lastname: Fossella
authors.forename: B S
authors.initials: BS
authors.lastname: Glisson
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: W K
authors.initials: WK
authors.lastname: Murphy
authors.forename: D M
authors.initials: DM
authors.lastname: Shin
authors.forename: B L
authors.initials: BL
authors.lastname: Kemp
authors.forename: J J
authors.initials: JJ
authors.lastname: Lee
authors.forename: J
authors.initials: J
authors.lastname: Kane
authors.forename: R A
authors.initials: RA
authors.lastname: Robinson
authors.forename: S M
authors.initials: SM
authors.lastname: Lippman
authors.forename: J M
authors.initials: JM
authors.lastname: Kurie
authors.forename: M H
authors.initials: MH
authors.lastname: Huber
authors.forename: M N
authors.initials: MN
authors.lastname: Raber
authors.forename: W K
authors.initials: WK
authors.lastname: Hong
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D019772:Topotecan; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan; D002166:Camptothecin