(1) In the absence of a reference treatment, @entity1 with metastatic @entity0 qualifying for cytotoxic chemotherapy are generally treated with the @entity632 + @entity786 combination. (2) Trastuzumab, a monoclonal antibody directed against @entity1722 protein, has been granted marketing authorisation for the treatment of metastatic @entity0 in @entity1 with high @entity1722 protein levels, either as third-line monotherapy, or as first-line combination therapy with @entity1311 . (3) The clinical file only comprises two trials, the results of which are difficult to interpret. (4) In second- or third-line monotherapy, the only available trial (a non comparative study involving 222 @entity1 ) gave a median survival time of 13 months. For want of comparative data, there is no way of knowing if the clinical benefit and adverse effects profile of trastuzumab are better than those of other cytotoxic agents. (5) In first- or second-line treatment, there is only one unblinded comparative trial: it compared four groups receiving @entity4349 + @entity786 + trastuzumab; @entity4349 + @entity786 ; @entity1311 + trastuzumab; or @entity1311 alone. The addition of trastuzumab appeared to extend the median survival time by 4-5 months. (6) The main known risks of trastuzumab therapy are cardiac reactions (the most severe) and @entity683 (the most frequent, occurring in 40% of @entity1 ). (7) In the two available trials, a retrospective analysis suggested that the impact of trastuzumab was related to the amount of @entity1722 protein in the @entity5 . Unfortunately, @entity1722 assays are poorly standardised. Approximately one-quarter of @entity1 appear to have high @entity5 @entity1722 protein contents. (8) At the time of writing (May 2001), the treatment of metastatic @entity0 is not modified by the advent of trastuzumab.

Trastuzumab: new preparation. May help some XXXX with @entity0 , but too many unknowns.

@entity1 :: ('9606', 'Species') :: ['women', 'patients'] @entity632 :: ('MESH:D004317', 'Chemical') :: ['doxorubicin'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity4349 :: ('CHEBI:48120', 'Chemical') :: ['anthracycline'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity683 :: ('MESH:D007251', 'Disease') :: ['flu-like syndromes'] @entity1722 :: ('2064', 'Gene') :: ['HER2']
@entity1 :: (9606,Species) :: ['patients']
