| Abstract | 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. |
| Authors | S Amat, P Bougnoux, F Penault-Llorca, F Fétissof, H Curé, F Kwiatkowski, J-L Achard, G Body, J Dauplat, P Chollet
(Affiliation: Centre Jean Perrin, 58 rue Montalembert, 63011 Clermont-Ferrand Cedex 1, France. recherche.clinique at cjp.u-clermont.fr)
|
| Journal | British journal of cancer
(Br J Cancer)
Vol. 88
Issue 9
Pg. 1339-45
(May 6 2003)
ISSN: 0007-0920 England |
| PMID | 12778058
(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
|
| Topics |
- 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
|
