title: Toxicity and activity of docetaxel in anthracycline-pretreated breast cancer patients: a phase II study.
abstract: Docetaxel has proven effective in advanced breast cancer. Myelosuppression and cumulative fluid retention syndrome are troublesome, potentially avoidable toxicities. In this consecutive cohort study, docetaxel (100 mg/m2 by 1 hour i.v. infusion, q3 weeks) activity and toxicity was explored in 56 anthracycline-pretreated patients (eligible: 55: median age: 51 years [range: 28-68 years]; median performance status: 0 [range: 0-3]) with metastatic breast cancer, using two different granulocyte colony-stimulating factor and steroid pre- and postmedication schedules. Twenty-nine patients (group A) received a 5-day oral prednisone premedication, and 26 (group B) received 4-day low-dose i.m. dexamethasone; group B patients also received prophylactic granulocyte colony-stimulating factor. All patients were evaluable for toxicity and 53 for response. Prophylactic granulocyte colony-stimulating factor significantly lowered the incidence of grade III-IV neutropenia and neutropenic fever (p = 0.0001 and 0.01, respectively). The incidence of moderate-severe fluid retention syndrome was lower in patients receiving i.m. dexamethasone (p = 0.08). Overall response rate was 53% (4 complete responses/24 partial responses, 95% confidence interval 39.4-66.2%); 32% have stable disease and 15% progressive disease. In 21 anthracycline-refractory/resistant patients, as well as in 10 paclitaxel-pretreated patients, the overall response rate was 50%. Docetaxel is highly active in anthracycline- and paclitaxel-pretreated metastatic breast cancer, with manageable toxicity. Optimal use of both granulocyte colony-stimulating factor support and steroid premedication deserves further investigation.
authors.affiliation: Division of Medical Oncology I, Regina Elena Cancer Institute, Rome, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Ferraresi
authors.forename: M
authors.initials: M
authors.lastname: Milella
authors.forename: A
authors.initials: A
authors.lastname: Vaccaro
authors.forename: A M
authors.initials: AM
authors.lastname: D'Ottavio
authors.forename: P
authors.initials: P
authors.lastname: Papaldo
authors.forename: C
authors.initials: C
authors.lastname: Nisticò
authors.forename: M F
authors.initials: MF
authors.lastname: Thorel
authors.forename: A
authors.initials: A
authors.lastname: Marsella
authors.forename: A
authors.initials: A
authors.lastname: Carpino
authors.forename: D
authors.initials: D
authors.lastname: Giannarelli
authors.forename: E
authors.initials: E
authors.lastname: Terzoli
authors.forename: F
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000494:pharmacology / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000494:pharmacology* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D003907:Dexamethasone / Q000008:administration & dosage; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced* / Q000517:prevention & control; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage; D043823:Taxoids
chemical_list: D018943:Anthracyclines; D000972:Antineoplastic Agents, Phytogenic; D005938:Glucocorticoids; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D003907:Dexamethasone; D017239:Paclitaxel; D011241:Prednisone