TEXAS (Taxotere experience with anthracyclines study): An evaluation of docetaxel combined with epirubicin or doxorubicin as first line chemotherapy for metastatic breast cancer

R. C. Leonard, K. M. Malinovszky, P. Barrett-Lee, S. Johnston, A. Howell

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Abstract

There is an ongoing need for novel treatments for metastatic breast cancer. We present an interim analysis of an open UK study looking at docetaxel (Taxotere) in combination with an anthracycline (either doxorubicin or epirubicin). This was set up to compare the efficacy and toxicity with that observed in the TAX 306 phase III trial (Nabholtz et al., ASCO 1999), and to gain experience of Taxotere in combination with an anthracycline as first-line chemotherapy for metastatic breast cancer in a wider community-based UK setting. Methods: 225 patients from 45 centres received at least 1 treatment cycle - 79 doxorubicin 50 mg/m2 and docetaxel 75 mg/m2, and 146 epirubicin 75mg/m2 and docetaxel 75mg/m2 both given D1 q 3 weeks. The recommended anthracycline dose was delivered in 94% of cycles for doxorubicin and 90% for epirubicin. The anthracycline used was at the treating clinicians' discretion. All 225 patients were included in the intention to treat population. Results: 158 patients (70%) had tumour response data provided at least once, having had 2 or more treatment cycles. Of these, 93 (59%) had a partial or complete response to treatment at some point during the study. There were no significant differences in response between the two treatment groups (doxorubicin 61%, epirubicin 58%, p=0.71). The response rate is similar to the AT arm of the phase III study (60%). The main clinical adverse event recorded was neutropenia. 91 patients (40%) required hospitalisation for neutropenia, 64 (28%)with neutropenia alone and 38 (17%)with febrile neutropenia or neutropenic sepsis (some patients had neutropenia and neutropenic sepsis). Again there was no significant difference between the two groups (doxorubicin 53%, epirubicin 41%, p=0.08). There was one death from neutropenic sepsis (0.4%) in the epirubicin arm. Conclusion: This is an interim analysis of an on-going study. The analysis suggests that epirubicin or doxorubicin used with docetaxel show similar efficacy, as first-line chemotherapy in metastatic breast cancer. These initial findings also show that response rates and toxic complications in a clinical setting were similar to those in the AT arm of a phase III study.

Original languageEnglish
Number of pages1
JournalBreast Cancer Research and Treatment
Volume69
Issue number3
Publication statusPublished - 1 Jan 2001

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