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Docetaxel for the adjuvant treatment of early node-positive breast cancer: a single technology appraisal.

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of docetaxel for the adjuvant treatment of early node-positive breast cancer based upon the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer's scope restricts the intervention to docetaxel in combination with doxorubicin and cyclophosphamide (TAC), and the comparator to anthracycline-based chemotherapy. Based on the BCIRG 001 trial, the submitted evidence shows that TAC is associated with superior disease-free and overall survival at 5 years compared with the anthracycline-based regimen FAC. The absolute risk reduction in patients treated with TAC compared with those treated with FAC was 7% for disease-free survival and 6% for overall survival. However, TAC was associated with significantly greater toxicity than FAC. There is also evidence that docetaxel, in an unlicensed sequential regimen FEC100-T, is associated with superior disease-free and overall survival at 5 years compared with FEC100. An economic model was developed by the manufacturer based on the BCIRG 001 trial. This generated central estimates of the cost per life-year gained and cost per quality-adjusted life-year (QALY) gained of TAC compared with FAC of 7900 pounds and 9800 pounds respectively. The manufacturer's submission predicts a cost-effectiveness of 15,000 pounds to 20,000 pounds per QALY gained for TAC compared with E-CMF (epirubicin in sequential therapy with cyclophosphamide, methotrexate, and fluorouracil), and estimates the cost-effectiveness of FEC100-T to be 8200 pounds per QALY compared with FEC100. Taking into account a number of issues identified by the ERG this may generate higher estimates of cost-effectiveness, but these are unlikely to exceed 35,000 pounds per QALY gained. Importantly, FAC is not commonly used in clinical practice in the UK and, therefore, the submitted evidence does not indicate whether TAC is superior to the anthracycline-based regimens that are in common use (FEC or E-CMF). The indirect comparisons presented suggest that the economic case for TAC in comparison to current UK practice may not be proven. The manufacturer's submission failed to record evidence of three serious adverse events in patients receiving docetaxel with doxorubicin or to mention the concern of the European Medicines Agency regarding TAC's long-term adverse events. The guidance issued by NICE in June 2006 as a result of the STA states that docetaxel, when given concurrently with doxorubicin and cyclophosphamide (the TAC regimen), is recommended as an option for the adjuvant treatment of women with early node-positive breast cancer.