title: A phase I study of 3-day topotecan and cisplatin in elderly patients with small-cell lung cancer.
abstract: OBJECTIVE
  The aim of this phase I study was to determine the maximum-tolerated dose (MTD) in elderly patients with small-cell lung cancer (SCLC).
  
  
  METHODS
  Patients aged over 75 years with previously untreated SCLC were enrolled in this study. Both topotecan and cisplatin were administered on days 1-3 and repeated every 3 weeks. The starting dose of topotecan was 0.5 mg/m2/day, while cisplatin was fixed at the dose of 20 mg/m2/day. Patients with limited disease (LD) SCLC received thoracic irradiation after the completion of chemotherapy.
  
  
  RESULTS
  Twenty-one elderly patients were enrolled in this study and received a total of 59 cycles. The major hematological toxicity was neutropenia and non-hematological toxicities including diarrhea were generally mild and reversible. The MTD of topotecan was determined as 1.2 mg/m2/day. The recommended phase II study dose of topotecan was determined as 1.0 mg/m2/day with cisplatin 20 mg/m2/day daily for 3 days. An objective response was observed in 6 of 10 patients (60%) with LD-SCLC and 6 of 11 (55%) with extensive disease (ED) SCLC. The median survival time in patients with LD-SCLC and those with ED-SCLC were 16.0 and 11.0 months, respectively.
  
  
  CONCLUSIONS
  The combination chemotherapy of 3-day topotecan and cisplatin appears to be tolerable and effective in elderly patients with SCLC.
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Okayama 701-1192, Japan. keiichi@okayama3.hosp.go.jp
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fujiwara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.forename: Shigeki
authors.initials: S
authors.lastname: Umemura
authors.forename: Keisuke
authors.initials: K
authors.lastname: Sugimoto
authors.forename: Takuo
authors.initials: T
authors.lastname: Shibayama
authors.forename: Haruhito
authors.initials: H
authors.lastname: Kamei
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.forename: Niro
authors.initials: N
authors.lastname: Okimoto
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan; D002945:Cisplatin