title: Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer).
abstract: BACKGROUND
  First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined.
  
  
  METHODS
  Women with stage III or IV breast cancer aged > or =70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80 mg/m(2) was administered weekly for 3 weeks every 28 days.
  
  
  RESULTS
  Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5-18.7) and median survival was 35.8 months (95% CI 19-not defined).
  
  
  CONCLUSIONS
  Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.
authors.affiliation: Department of Medical Oncology, National Cancer Research Institute, Largo Rosanna Benzi 10, 16132 Genoa, Italy. lucia.delmastro@istge.it
authors.forename: L
authors.initials: L
authors.lastname: Del Mastro
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: L
authors.initials: L
authors.lastname: Repetto
authors.forename: L
authors.initials: L
authors.lastname: Manzione
authors.forename: V
authors.initials: V
authors.lastname: Zagonel
authors.forename: L
authors.initials: L
authors.lastname: Fratino
authors.forename: D
authors.initials: D
authors.lastname: Marenco
authors.forename: M
authors.initials: M
authors.lastname: Venturini
authors.forename: E
authors.initials: E
authors.lastname: Maggi
authors.forename: C
authors.initials: C
authors.lastname: Bighin
authors.forename: T
authors.initials: T
authors.lastname: Catzeddu
authors.forename: A
authors.initials: A
authors.lastname: Venturino
authors.forename: R
authors.initials: R
authors.lastname: Rosso
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel