title: A phase II trial of a biweekly combination of paclitaxel and gemcitabine in metastatic breast cancer.
abstract: BACKGROUND
  Many emerging new drugs have recently been trialled for treatment of early and advanced breast cancer. Among these new agents paclitaxel and gemcitabine play a crucial role, mostly in patients with relapsed and metastatic disease after failure of chemotherapy with antracyclines.
  
  
  METHODS
  A phase II study was started in order to evaluate the activity and toxicity of a combination of paclitaxel and gemcitabine in a biweekly schedule on metastatic breast cancer patients previously treated with antracyclines.
  
  
  RESULTS
  Twenty-five patients received paclitaxel (150 mg/mq) by 3-hours infusion, followed by gemcitabine (2000 mg/mq) given as a 60 min i.v. infusion (day 1-14) for a maximum of eight cycles. In all patients treatment was evaluated for toxicity and efficacy; four patients (16%) achieved a complete response, 12 (48%) a partial response giving an overall objective response rate of 64%. Stable disease was documented in 5 patients (20%) and progressive disease occurred in 4 patients (16%).
  
  
  CONCLUSIONS
  The schedule of treatment was safe and tolerable from a haematological and non-haematological point of view. These data confirm that the combination of gemcitabine and paclitaxel on a biweekly basis is an effective and well-tolerated regimen in breast cancer patients with prior therapeutic exposure to antracyclines.
authors.affiliation: Department of Clinical Oncology, Regina Elena Cancer Institute of Rome, Via Chianesi, 53, 00100 Rome, Italy. silverio.tomao@uniroma1.it
authors.forename: Silverio
authors.initials: S
authors.lastname: Tomao
authors.forename: Adriana
authors.initials: A
authors.lastname: Romiti
authors.forename: Federica
authors.initials: F
authors.lastname: Tomao
authors.forename: Marisa
authors.initials: M
authors.lastname: Di Seri
authors.forename: Giuliana
authors.initials: G
authors.lastname: Caprio
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Spinelli
authors.forename: Edmondo
authors.initials: E
authors.lastname: Terzoli
authors.forename: Luigi
authors.initials: L
authors.lastname: Frati
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine