A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trials Group.
Ann Oncol
; 5(6): 527-32, 1994 Jul.
Article
in En
| MEDLINE
| ID: mdl-7918124
ABSTRACT
BACKGROUND:
Docetaxel, a semisynthetic analog of paclitaxel, made for the needles of the European yew, Taxus baccata, is a potentially important chemotherapeutic agent for the treatment of cancer. PATIENTS ANDMETHODS:
In a phase II study patients with advanced and/or metastatic breast cancer and bidimensionally measurable disease, were treated with docetaxel 100 mg/m2 every 3 weeks as a 1 hour infusion without any premedication. Treatment was evaluated after 2 courses and every 2 subsequent courses.RESULTS:
Thirty-nine patients were entered, 32 were eligible. The eligible patients had a median age of 51 years (range 30-73) and a performance status WHO 1 median, (range 0-2). Twenty-eight patients had been treated with surgery, 24 with radiation. Hormonal treatment was previously given in 23, chemotherapy in 32. Of 24 patients treated as second line strategy, 13 achieved a partial remission, 1 a complete remission (overall response rate 58% (95% CI 37%-78%)). Eight patients treated as first line 2 PR's, 1 CR. The median overall response duration was 38 weeks. The main toxicity consisted of transient grade 4 neutropenia in 149 of 167 evaluable courses (89%). However, the related infection rate was low. Re-treatment at 3 weeks, as scheduled, was nearly always possible. Other toxicities consisted of skin reactions (81%) and nail changes (41%), neurosensory toxicity (59%) and occasionally hypersensitivity reactions (16%). Fluid retention was a toxicity of major concern, observed in 59% of patients.CONCLUSION:
Docetaxel is a very active drug against breast cancer. Further studies are required to alleviate the non-hematological toxicities.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Breast Neoplasms
/
Paclitaxel
/
Taxoids
/
Antineoplastic Agents, Phytogenic
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Ann Oncol
Journal subject:
NEOPLASIAS
Year:
1994
Document type:
Article