title: Teniposide (VM-26) as a single drug treatment for patients with extensive small cell lung carcinoma: a Phase II study of the Southwest Oncology Group.
abstract: BACKGROUND
  Teniposide (VM-26) was reported to have activity in small cell lung carcinoma (SCLC). The authors performed a Phase II study of teniposide as a treatment for patients with previously untreated extensive SCLC.
  
  
  METHODS
  The study was open to patients with a histologic or cytologic diagnosis of extensive SCLC who had not received prior radiation or chemotherapy. Patients with hematologic values below normal were considered eligible if the impaired bone marrow function was directly attributable to disease involvement. Treatment consisted of teniposide 60 mg/m2 given intravenously (i.v.) on Days 1-5 every 3 weeks.
  
  
  RESULTS
  This study opened on September 15, 1988, closed permanently on November 15, 1990, and accrued 45 patients identified at 19 academic, military, and Community Clinical Oncology Program institutions affiliated with the Southwest Oncology Group. Of the 45 registered patients, 41 were eligible. Twenty eight (68%) were males and 13 (32%) were females; the median age was 64 years (minimum, 46 years; maximum, 83 years). Twenty-four patients (59%) had a performance status (PS) on the Zubrod scale of 0-1 and 17 cases (41%) had a PS of 2. Of the 41 eligible patients, 10 had confirmed partial responses (24%) (95% confidence interval, 12-40%). The median survival was 7 months. The significant toxicities noted were Grade 4 leukopenia and/or granulocytopenia, experienced by 15 patients; 1 of these patients also had Grade 4 hyponatremia. One patient died of a respiratory infection.
  
  
  CONCLUSIONS
  When administered according to the dosage and schedule selected for this study (60 mg/m2 i.v. on Days 1-5 every 3 weeks), teniposide as a single agent had modest activity in extensive small cell lung carcinoma. The toxicities observed in this study were acceptable.
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, USA.
authors.forename: P N
authors.initials: PN
authors.lastname: Grozea
authors.forename: J J
authors.initials: JJ
authors.lastname: Crowley
authors.forename: V A
authors.initials: VA
authors.lastname: Canfield
authors.forename: L
authors.initials: L
authors.lastname: Kingsbury
authors.forename: S W
authors.initials: SW
authors.lastname: Ross
authors.forename: G S
authors.initials: GS
authors.lastname: Beltran
authors.forename: L R
authors.initials: LR
authors.lastname: Laufman
authors.forename: G R
authors.initials: GR
authors.lastname: Weiss
authors.forename: R B
authors.initials: RB
authors.lastname: Livingston
mesh_terms: D000206:Actuarial Analysis; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D013713:Teniposide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D013713:Teniposide