title: Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer.
abstract: BACKGROUND
  This phase II study was conducted to evaluate the safety and efficacy of the combination of paclitaxel and topotecan for patients with extensive stage small-cell lung cancer (ED-SCLC).
  
  
  METHODS
  Previously untreated ED-SCLC patients with Eastern Coperative Oncology Group performance status <2 were eligible. Treatment consisted of topotecan 1 mg/m2 (first three patients received 1.25 mg/m2), on days 1-5, and paclitaxel 135 mg/m2 over 24 h on day 5, every 4 weeks. Prophylactic granulocyte colony-stimulating factor was administered to all patients.
  
  
  RESULTS
  Thirty-two patients received a median of four cycles of chemotherapy. Grade 4 anemia, neutropenia and thrombocytopenia occurred in 13, 31 and 18 patients, respectively. Thirty episodes of febrile neutropenia occurred in 22 patients. Grade 3 fatigue, esophagitis, stomatitis and hypotension occurred in one patient each. Of 26 patients eligible for response evaluation, there were six complete and 12 partial responses (overall response rate 69%). The median survival was 54 weeks. The 1-, 2- and 3-year survival rates were 50%, 10% and 3%, respectively.
  
  
  CONCLUSIONS
  The combination of topotecan and paclitaxel is active as initial therapy in SCLC, but the efficacy is similar to 'standard therapy'. This combination was associated with a high incidence of myelosuppression and febrile neutropenia, at the doses evaluated.
authors.affiliation: University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ramalingam
authors.forename: C P
authors.initials: CP
authors.lastname: Belani
authors.forename: R
authors.initials: R
authors.lastname: Day
authors.forename: B A
authors.initials: BA
authors.lastname: Zamboni
authors.forename: S A
authors.initials: SA
authors.lastname: Jacobs
authors.forename: J R
authors.initials: JR
authors.lastname: Jett
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D019772:Topotecan; D017239:Paclitaxel