title: Phase I study of irinotecan and amrubicin in patients with advanced non-small-cell lung cancer.
abstract: BACKGROUND
  Combination chemotherapy of irinotecan and amrubicin for advanced non-small cell lung cancer (NSCLC) has not been fully evaluated. To determine the maximum-tolerated dose (MTD), a phase I study in patients with advanced NSCLC was conducted.
  
  
  METHODS
  Patients with stage IIIB/IV NSCLC were enrolled in this study. Both patients with and without prior chemotherapy were also eligible. The drugs were administered on days 1 and 8, every 3 weeks. The starting doses of irinotecan and amrubicin were 60 and 35 mg/m2, respectively.
  
  
  RESULTS
  Nineteen patients received a total of 53 courses. Grade 4 neutropenia was observed in 23% of courses. Anaemia and thrombocytopenia were generally mild. Grade 3 febrile neutropenia occurred in 5 courses. Other grade 3 or greater non-haematological toxicities were observed in only 4 out of 52 courses (grade 3 infection and hyponatremia). The maximum-tolerated doses (MTDs) of irinotecan and amrubicin were 100 and 45 mg/m2, respectively. Objective response was obtained in 2 patients (10.5%), who had received prior chemotherapy.
  
  
  CONCLUSIONS
  This combination was well tolerated, but produced only a modest anti-tumour effect for advanced NSCLC. Further investigation into the role of this regimen as a salvage chemotherapy may be warranted in relapsed patients.
authors.affiliation: Department of Medicine II, Okayama University Medical School, 2-5-1, Shikata-cho, Okayama, 700-8558, Japan. khotta@md.okayama-u.ac.jp
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Shigeki
authors.initials: S
authors.lastname: Umemura
authors.forename: Atsuko
authors.initials: A
authors.lastname: Ogino
authors.forename: Akiko
authors.initials: A
authors.lastname: Uchida
authors.forename: Akihiro
authors.initials: A
authors.lastname: Bessho
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Segawa
authors.forename: Tetsu
authors.initials: T
authors.lastname: Shinkai
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.forename: Niro
authors.initials: N
authors.lastname: Okimoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007010:Hyponatremia / Q000139:chemically induced; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D018943:Anthracyclines; D000077146:Irinotecan; C055866:amrubicin; D002166:Camptothecin