Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate.

Docetaxel (Taxotere), alone or in combination with other anticancer agents, has proven efficacy in the first- and second-line treatment of metastatic breast cancer. This phase II study investigated the efficacy and tolerability of docetaxel as neoadjuvant chemotherapy in women with stage II-III primary operable breast cancer. Patients (n=88) were treated with six cycles of docetaxel at 100 mg m(-2) every 21 days, followed by definitive surgery and radiotherapy. After six cycles of docetaxel, the overall clinical response rate was 68.4% (CI 95%: 58.1-78.7%), including 19.0% complete remissions. Breast conservation was achieved in 72.4% of patients. A high pathological complete response (pCR) rate in breast was confirmed in 15 patients (19.8% (CI 95%: 10.8-28.8%)) on Chevallier's classification restricted to breast and in 27 patients (35.5% (CI 95%: 24.7-46.3%)) on Sataloff's classification. After a median follow-up of 30.8 months, 19 recurrences were documented with a median time to first recurrence of 17.3 months. Patients with stage III tumours had more recurrences than patients with stage II tumours (P=0.02). The principal toxicity of docetaxel is myelosuppression and 70.5% of patients developed grade III or IV neutropenia with 13.6% developing neutropenic sepsis. There was no case of severe cardiac toxicity, thrombocytopenia or any other serious adverse events. In conclusion, neoadjuvant docetaxel induces a high pCR and breast-conservation rate. Docetaxel monotherapy is a highly effective regimen that merits formal comparison with currently used combination regimens in a randomised phase III study.
AuthorsS Amat, P Bougnoux, F Penault-Llorca, F Fétissof, H Curé, F Kwiatkowski, J-L Achard, G Body, J Dauplat, P Chollet
JournalBritish journal of cancer (Br J Cancer) Vol. 88 Issue 9 Pg. 1339-45 (May 6 2003) ISSN: 0007-0920 [Print] England
PMID12778058 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents, Phytogenic
  • Receptors, Estrogen
  • Receptors, Progesterone
  • Taxoids
  • docetaxel
  • Paclitaxel
  • Methylprednisolone
  • Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
  • Blood Cell Count
  • Breast Neoplasms (drug therapy, mortality, pathology, radiotherapy, surgery)
  • Chemotherapy, Adjuvant
  • Drug Administration Schedule
  • Female
  • Humans
  • Injections, Intravenous
  • Methylprednisolone (therapeutic use)
  • Neoplasm Invasiveness
  • Neoplasm Staging
  • Paclitaxel (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Receptors, Estrogen (analysis)
  • Receptors, Progesterone (analysis)
  • Recurrence
  • Survival Analysis
  • Taxoids
  • Treatment Outcome

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