A PHASE-II TRIAL WITH DOCETAXEL (TAXOTERE(TM)) IN 2ND LINE TREATMENT WITH CHEMOTHERAPY FOR ADVANCED BREAST-CANCER - A STUDY OF THE EORTC EARLY CLINICAL-TRIALS GROUP

Background: Docetaxel, a semisynthetic analog of paclitaxel, made for the needles of the European yew, Taxus baccata, is a potentially impor tant chemotherapeutic agent for the treatment of cancer. Patients and methods: In a phase II study patients with advanced and/or metastatic breast cancer and bidimensionally measurable disease, were treated wit h docetaxel 100 mg/m2 every 3 weeks as a 1 hour infusion without any p remedication. Treatment was evaluated after 2 courses and every 2 subs equent courses. Results: Thirty-nine patients were entered, 32 were el igible. The eligible patients had a median age of 51 years (range 30-7 3) and a performance status WHO 1 median, (range 0-2). Twenty-eight pa tients had been treated with surgery, 24 with radiation. Hormonal trea tment was previously given in 23, chemotherapy in 32. Of 24 patients t reated as second line strategy, 13 achieved a partial remission, 1 a c omplete remission (overall response rate 58% (95% CI 37%-78%)). Eight patients treated as first line: 2 PR's, 1 CR. The median overall respo nse duration was 38 weeks. The main toxicity consisted of transient gr ade 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 reacti ons (81%) and nail changes (41%), neurosensory toxicity (59%) and occa sionally hypersensitivity reactions (16%). Fluid retention was a toxic ity of major concern, observed in 59% of patients.Conclusion: Docetaxe l is a very active drug against breast cancer. Further studies are req uired to alleviate the non-hematological toxicities.