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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.
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
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 23 Issue 2 Pg. 132-9 (Apr 2000) ISSN: 0277-3732 [Print] 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
  • Granulocyte Colony-Stimulating Factor
  • docetaxel
  • Dexamethasone
  • Paclitaxel
  • 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

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