TAXOTERE (docetaxel), antineoplastic agent
Reason for request
In combination with doxorubicin and cyclophosphamide, the actual benefit of TAXOTERE is insufficient in the treatment of operable node-negative breast cancer, according to the TAC protocol (TAXOTERE, Adriamycin, cyclophosphamide)
» TAXOTERE now has Marketing Authorisation in the adjuvant treatment of operable, node-negative breast cancer, in combination with doxorubicin and cyclophosphamide.
» The benefit of TAXOTERE on use of the TAC protocol (TAXOTERE, Adriamycin, cyclophosphamide) is analysed as regards the reduction in the risk of recurrence versus haematological toxicity (febrile neutropenia).
» Given the availability of alternatives with fewer haematological adverse effects, TAXOTERE administered concomitantly with cyclophosphamide and Adriamycin (TAC) has no role in the adjuvant treatment of node-negative breast cancer.
» Outside the TAC protocol, TAXOTERE retains its role in the adjuvant treatment of breast cancer (sequential regimen of FEC 100 followed by TAXOTERE).