Despite progressive developments in therapeutic interventions, Including su
rgery, radiotherapy and chemotherapy, there has been no major Improvement i
n the survival of women with metastatic breast cancer (MBC). Based on knowl
edge of tumor growth patterns, approaches addressing this Issue have includ
ed increasing chemotherapy dose or dose density and extending the duration
of therapy. However, only the latter approach has resulted in improved clin
ical benefit, although not survival; and its use is restricted by the cumul
ative toxicity of chemotherapeutic agents. Therefore, the best hope for imp
roved survival lies with new classes of anticancer drug and particularly bi
ological agents. This review focuses on the first oncogene-targeted therapy
for human epidermal growth factor receptor-2 (HER2)(+) MBC patients. The h
umanized anti-HER2 monoclonal antibody Herceptin A, has proven clinical ben
efits In HER2(+) MBC patients, most importantly improved survival, and is r
apidly becoming a standard of care for these patients. In contrast to the f
ixed number of cycles used for chemotherapeutic agents, Herceptin is admini
stered until disease progression, with some data suggesting that continuati
on beyond disease progression should be investigated. The preclinical and c
linical findings on which the current recommended duration of Herceptin the
rapy are based are reviewed and alternative strategies are discussed. [(C)
2001 Lippincott Williams & Wilkins.].