The use of paclitaxel in the management of early stage breast cancer.

Authors' conclusions The submission did not include a systematic review for clinical or cost-effectiveness evidence. As a result, potentially relevant trials and previously published studies were omitted. The main comparator used did not represent standard care in the UK NHS and a large number of relevant comparators were omitted, including docetaxel, another taxane, as licensed for the same indication. The manufacturer did not consider potentially important patient subgroups defined by baseline risk, and the cost-effectiveness result in the average overall patient population may conceal important variation between subgroups. Overall, although the economic model may have indicated that the addition of four cycles of paclitaxel to four cycles of AC may be cost-effective compared with providing four cycles of AC only, this comparison is not informative to current clinical practice in the UK NHS. In the context of this review it is not possible for the ERG to predict the cost-effectiveness of paclitaxel compared with more appropriate, and potentially more effective, relevant comparators such as six cycles of FAC or the licensed indication of docetaxel. It is therefore impossible for the ERG to predict what effect including these comparators would have on the cost-effectiveness of paclitaxel for adjuvant treatment of early breast cancer.