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Toxicity and activity of docetaxel in anthracycline-pretreated breast cancer patients: a phase II study.

AbstractDocetaxel 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.
AuthorsV Ferraresi, M Milella, A Vaccaro, A M D'Ottavio, P Papaldo, C Nisticò, M F Thorel, A Marsella, A Carpino, D Giannarelli, E Terzoli, F Cognetti (Affiliation: Division of Medical Oncology I, Regina Elena Cancer Institute, Rome, Italy.)
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 23 Issue 2 Pg. 132-9 (Apr 2000) ISSN: 0277-3732 UNITED STATES
PMID10776972 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Anthracyclines
  • Antineoplastic Agents, Phytogenic
  • Glucocorticoids
  • Taxoids
  • docetaxel
  • Granulocyte Colony-Stimulating Factor
  • Paclitaxel
  • Dexamethasone
  • Prednisone
Topics
  • Adult
  • Aged
  • Anthracyclines (pharmacology, therapeutic use)
  • Antineoplastic Agents, Phytogenic (adverse effects, pharmacology, therapeutic use)
  • Breast Neoplasms (drug therapy, pathology)
  • Cohort Studies
  • Dexamethasone (administration & dosage)
  • Drug Resistance, Neoplasm
  • Female
  • Glucocorticoids (administration & dosage)
  • Granulocyte Colony-Stimulating Factor (administration & dosage)
  • Humans
  • Infusions, Intravenous
  • Middle Aged
  • Neutropenia (chemically induced, prevention & control)
  • Paclitaxel (adverse effects, analogs & derivatives, pharmacology, therapeutic use)
  • Prednisone (administration & dosage)
  • Taxoids