Abstract
Purpose
The TEXAS (Taxotere® EXperience with Anthracyclines Study) study examined docetaxel in combination with an anthracycline, as first line treatment of metastatic breast cancer (MBC), in everyday practice, and compared the findings with a randomised controlled trial.
Methods
Four hundred and seventy patients were registered on the TEXAS trial. Patients were assigned, according to treating clinician’s discretion, to either doxorubicin 50 mg/m2 or epirubicin 75 mg/m2 both given day1 15 min intravenous bolus every 3 weeks, followed by docetaxel 75 mg/m2, day 1, 1 h intravenous infusion every 3 weeks.
Results
The overall response rate (ORR) was approximately 61%. The main toxicity reported was neutropenia, with 75 patients (55%) in the AT group and 203 (61%) in the ET arm. Febrile neutropenia or neutropenic sepsis was reported for 32 (24%) of the AT arm and 78 (23%) of the ET arm.
Conclusions
This open access study demonstrates that AT or ET are highly active treatments for MBC, with similar response rates to those observed in a phase III clinical trial. This may be important for patients with rapidly progressive visceral disease. Side effects can be managed effectively with growth factors and/or prophylactic antibiotic.
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References
Ellis MJ, Hayes DF, Lippman ME (2000) Treatment of metastatic breast cancer. In: Lippman ME, Morrow M, Osborne CK (eds) Diseases of the breast. Lippincott, Philadelphia, pp 749–797
Chan S, Friedrichs K, Noel D et al (1999) Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer: the 303 study group. J Clin Oncol 17:2341–2354
Nabholz J-M, Riva A (2001) Taxane/anthracycline combinations: setting a new standard in breast cancer? Oncologist 6(suppl 3):5–12
Sledge GW, Neuberg D, Bernardo P et al (2003) Phase III trial of Doxorubicin and Paclitaxel, and the combination of Doxorubicin and Paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial. J Clin Oncol 21(4):588–592
Nabholtz J, Falkson C, Campos D et al (2003) for the TAX 306 study group. docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 21(6):968–975
Bonneterre J, Dieras V, Tubiana-Hulin M et al. (2001) 6 cycles of epirubicin/docetaxel (ET) versus six cycles of 5FU epirubicin/cyclophosphamide (FEC) as first line metastatic breast cancer (MBC) treatment. Proc Am Soc Clin Oncol 20:42a [Abstract 163]
O’Brien MER, Leonard RC, Barrett-Lee PJ et al (1999) Docetaxel in the community setting: an analysis of 377 breast cancer patients treated with docetaxel (Taxotere) in the UK. Ann Oncol 10:205–210
Iveson T, Eggleton SPH, Hickish T et al (1998) Campto (Irinotecan, CPT11) in 5-FU pretreated advanced colorectal cancer: results in 174 expanded access patients. Proc ESMO [Abstract 174P]
Nabholtz JM, Senn HJ, Bezwoda WR et al (1999) Prospective randomized trial of docetaxel versus mitomycin C plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol 17:1413–1424
Paridaens R, Biganzoli L, Bruning P et al (2000) Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol 18:724–733
Fossati R, Confalonieri C, Torri V et al (1998) Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,150 women. J Clin Oncol 16:3439–3460
Zambetti M, Moliterni A, Materazzo C et al (2001) Long-term cardiac sequelae in operable breast cancer patients given adjuvant chemotherapy with or without doxorubicin and breast irradiation. J Clin Oncol 19:37–43
Schuller JA, Czeika M, Kletzl H et al (1998) Doxorubicin and taxotere: a pharmacokinetic study of the combination in advanced breast cancer. Proc Am Soc Clin Oncol 17(205a, abstr 790)
Bellot R, Robert J, Dieras V et al (1998) Taxotere does not change the pharmacokinetic profile of doxorubicin and doxorubicinol. Proc Am Soc Clin Oncol 17 (221a, abstr 853)
Biganzoli L, Cufer T, Bruning P et al (2002) Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial. J Clin Oncol 20:3114–3121
Luck HJ, Thomssen C, Untch M et al (2000) Multicentric phase III study in first line treatment of advanced metastatic breast cancer (ABC): epirubicin/paclitaxel (ET) vs epirubicin/cyclophosphamide (EC): a study of the AGO Breast Cancer Group. Proc Am Soc Clin Oncol 19 (73a, abstr 280)
Carmichael J (2001) UKCCR trial of epirubicin and cyclophosphamide (EC) vs. epirubicin and Taxol (ET) in the first line treatment of women with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 20 (22a, abstr 84)
Jassem J, Pienowski T, Plzanka A et al (2001) Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial. J Clin Oncol 9:1707–1715
Jones SE, Erban B, Overmoyer GT et al (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542–5551
Seidman AD, Berry D, Cirrincione C et al (2004) CALGB 9840: phase III study of weekly (W) paclitaxel (P) via 1-hour (h) infusion versus standard (S) 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol 22:14S Abstract 512
O’Shaughnessy J, Nag S, Calderillo-Ruiz J et al (2003) Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Interim results of a global phase III study. Proc Am Soc Clin Oncol 22:7 Abstract 25
O’Shaughnessy J, Miles D, Vukelja S et al (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812–2823
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Conflict of interest: An educational grant was provided from Aventis to organise the study. Taxotere was provided free of charge for patients in the study.
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Malinovszky, K., Johnston, S., Barrett-Lee, P. et al. TEXAS (Taxotere® EXperience with Anthracyclines Study) trial: mature results of activity/toxicity of docetaxel given with anthracyclines in a community setting, as first line therapy for MBC. Cancer Chemother Pharmacol 59, 413–418 (2007). https://doi.org/10.1007/s00280-006-0303-9
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DOI: https://doi.org/10.1007/s00280-006-0303-9