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

Virginia Ferraresi, Michele Milella, Angela Vaccaro, Anna Maria D'Ottavio, Paola Papaldo, Cecilia Nisticò, Maria Francesca Thorel, Annelisa Marsella, Armando Carpino, Diana Giannarelli, Edmondo Terzoli, Francesco Cognetti

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)132-139
Number of pages8
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number2
Publication statusPublished - 2000


  • Anthracycline, pretreated
  • Docetaxel
  • G-CSF
  • Metastatic breast cancer
  • Paclitaxel, pretreated
  • Premedication
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


Dive into the research topics of 'Toxicity and activity of docetaxel in anthracycline-pretreated breast cancer patients: A phase II study'. Together they form a unique fingerprint.

Cite this