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TAXOTERE (docetaxel), antineoplastic agent

ONCOLOGY - New indication
Opinions on drugs - Posted on Jun 01 2015

Reason for request

Extension of indication

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).


Actual benefit

Insuffisant

-


Therapeutic use

-

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