title: Biweekly docetaxel-irinotecan treatment with filgrastim support is highly active in antracycline-Paclitaxel-refractory breast cancer patients.
abstract: OBJECTIVE
  To evaluate the feasibility and activity of combination treatment with docetaxel (DTX) and irinotecan (CPT-11), given together every other week, combined with filgrastim support, in anthracycline- and paclitaxel-pretreated breast cancer (BC) patients.
  
  
  METHODS
  Advanced BC patients pretreated with anthracycline- and paclitaxel-based chemotherapy were eligible. DTX (80 mg/m2) and CPT-11 (100 mg/m2) were given biweekly with filgrastim support (300 microg/day on days 4-7).
  
  
  RESULTS
  Fifty patients (48 with metastatic and 2 with locally advanced cancer) were enrolled, with a total of 318 cycles being delivered. Thirty-one patients had visceral localizations. All patients had received epirubicin plus paclitaxel, with or without cisplatin, as front-line treatment for advanced disease. Overall, fatigue and diarrhea were the main chemotherapy-related toxicities in this study, being severe in 10 (20%) and 4 (8%) patients. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 18 (36%) and 6 (12%) patients, respectively. Red blood cell transfusions were required in 4 patients. A total of 32 objective responses were registered (overall response rate, ORR = 64%, 95% confidence interval = 49-77%), including 8 complete responses (16%). An additional 8 patients showed stable disease. After a median follow-up of 18 (range 4-29) months, 30 patients were still alive, and 19 were progression free; median progression-free and overall survivals were 10 and 23 months, respectively.
  
  
  CONCLUSIONS
  Biweekly DTX/CPT-11 with G-CSF support is a well-tolerated and highly effective approach in anthracycline-/paclitaxel-pretreated patients. The very promising ORR and survival outcome observed in this subset of patients with a poor prognosis suggest that this regimen might play a major role in the management of this disease.
authors: Division of Medical Oncology A, National Cancer Institute of Naples, Naples, and Department of Surgery, Pagani General Hospital, Salerno, Italy. giuseppefrasci@libero.it
authors: Giuseppe
authors: G
authors: Frasci
authors: Giuseppe
authors: G
authors: D'Aiuto
authors: Renato
authors: R
authors: Thomas
authors: Pasquale
authors: P
authors: Comella
authors: Maurizio
authors: M
authors: Di Bonito
authors: Liliana
authors: L
authors: Lapenta
authors: Massimiliano
authors: M
authors: D'Aiuto
authors: Gerardo
authors: G
authors: Botti
authors: Paolo
authors: P
authors: Vallone
authors: Vincenzo
authors: V
authors: De Rosa
authors: Roberta
authors: R
authors: D'Aniello
authors: Renato
authors: R
authors: Giordano
authors: Giuseppe
authors: G
authors: Comella
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005240:Feasibility Studies; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011994:Recombinant Proteins; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D018943:Anthracyclines; D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D000077146:Irinotecan; D017239:Paclitaxel; D000069585:Filgrastim; D002166:Camptothecin