Annals of Oncology 5:527-532, 1994
© 1994 European Society for Medical Oncology
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A phase II trial with Docetaxel (TaxotereTM) in second line treatment with chemotherapy for advanced breast cancer
A study of the EORTC Early Clinical Trials Group
1Netherlands Cancer Institute Amsterdam, The Netherlands
2Universitair Ziekenhuis Antwerpen
3Institut Jules Bordet Brussels, Belgium
4Beatson Cancer Center Glasgow, U.K.
5Institut Gustave Roussy Paris, France
6New Drug Development Office Amsterdam, The Netherlands
7Centre Régional Léon Bérard Lyon, France
8Daniël den Hoed Cancer Center Rotterdam, The Netherlands
9 Rhône-Poulenc Rorer, Antony, Paris, France
Correspondence to: W. W. ten Bokkel Huinink, M.D., Dept. of Medical Oncology, Netherlands Cancer Institute Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
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 AND METHODS: 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.
docetaxel, breast cancer
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