title: Topotecan in the treatment of brain metastases. A phase II study of GOIM (Gruppo Oncologico dell'Italia Meridionale).
abstract: BACKGROUND
  Topotecan is able to cross the blood-brain barrier (BBB) and has been demonstrated to be active in brain metastases from small cell lung cancer (SCLC).
  
  
  METHODS
  The aim of this study was to evaluate the efficacy and toxicity of topotecan at a dosage of 1.5 mg/m2 for 5 consecutive days every 3 weeks in patients with brain metastases from various neoplasms.
  
  
  RESULTS
  Among the 19 patients enrolled, objective responses were observed in 2 out of 3 patients affected by brain metastases from SCLC. Stable disease was observed in 8 more patients (4 breast, 3 non-SCLC and 1 colon). According to the Simon two-step design, patient accrual was stopped because of the low response rate observed in the first 19 patients treated (early stopping rule). The G 3/4 haematological toxicity was severe, with 37% neutropenia, 21% thrombocytopenia and 16% anaemia, respectively.
  
  
  CONCLUSIONS
  Our data do not support the use of topotecan in patients with brain metastases, except for SCLC. In addition, the haematological toxicity prevents the use of this regimen in elderly and poor performance status patients.
authors.affiliation: Medical Oncology Department, Oncology Institute, Via Amendola 209, 70123 Bari, Italy. vitolorusso@inwind.it
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Francesco
authors.initials: F
authors.lastname: Giotta
authors.forename: Antonio
authors.initials: A
authors.lastname: Rinaldi
authors.forename: Sante
authors.initials: S
authors.lastname: Romito
authors.forename: Cosimo
authors.initials: C
authors.lastname: Brunetti
authors.forename: Nicola
authors.initials: N
authors.lastname: Silvestris
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology; D018288:Carcinoma, Small Cell / Q000188:drug therapy / Q000556:secondary; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan