title: Doxorubicin-docetaxel sequential schedule: results of front-line treatment in advanced breast cancer.
abstract: OBJECTIVE
  We conducted a multi-institutional phase II study to evaluate the tolerability and activity of a sequential schedule of treatment with doxorubicin and docetaxel in chemotherapy-naive women with advanced breast cancer.
  
  
  METHODS
  A total of 73 patients with PS (ECOG) 0-2, aged <70 years and adequate bone marrow, renal, liver and cardiac functions were included in the study (13 stage III B and 60 stage IV). The schedule of administration was doxorubicin 50 mg/m2 by intravenous (i.v.) 30 min injection on day 1 followed the day after by docetaxel 75 mg/m2, by i.v. 60 min infusion. Cycles were repeated every 28 days.
  
  
  RESULTS
  Overall, the median number of administered cycles was 6 (range 1-14). The most common toxicity was hematological, with 56.2% of the patients who experienced grade 3-4 neutropenia. However, febrile neutropenia occurred only in 2.8% of the cases. The median cumulative dose of doxorubicin was 350 mg/m2 (range 50-700 mg/m2). Eleven patients (15.4%) were documented to have >10% but <20% decrease in the left ventricular ejection fraction. No case of congestive heart failure was recorded. No patient experienced treatment-related death. Among the 68 evaluable patients, the overall objective response rate was 73.5% (95% confidence limits: 63-84%): 10 patients (14.7%) obtained a complete remission and 40 (58.8%) had a partial response. Only 10 patients (14.7%) experienced progressive disease. The median duration of response was 10 months (2-54+).
  
  
  CONCLUSIONS
  This sequential treatment with doxorubicin and docetaxel is an effective, feasible and a well-tolerated regimen. The main toxicity was neutropenia. The lack of cardiotoxicity is an important advantage of such a doxorubicin-docetaxel combination and it justifies phase III comparative studies with other anthracyclines/taxanes containing schedules in both advanced and early-stage breast cancer.
authors.affiliation: Istituto di Clinica Medica, Cattedra di Oncologia Medica, Università di Palermo, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Palmeri
authors.forename: V
authors.initials: V
authors.lastname: Leonardi
authors.forename: M
authors.initials: M
authors.lastname: Tamburo De Bella
authors.forename: A
authors.initials: A
authors.lastname: Morabito
authors.forename: M
authors.initials: M
authors.lastname: Vaglica
authors.forename: V
authors.initials: V
authors.lastname: Accurso
authors.forename: F
authors.initials: F
authors.lastname: Ferraù
authors.forename: G
authors.initials: G
authors.lastname: Failla
authors.forename: B
authors.initials: B
authors.lastname: Agostara
authors.forename: B
authors.initials: B
authors.lastname: Massidda
authors.forename: R
authors.initials: R
authors.lastname: Valenza
authors.forename: M
authors.initials: M
authors.lastname: Fanelli
authors.forename: G
authors.initials: G
authors.lastname: Gasparini
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015996:Survival Rate; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D017239:Paclitaxel