EFFICACY AND TOLERABILITY OF TRASTUZUMAB (HERCEPTIN) IN A

CONSECUTIVE SERIES OF METASTATIC BREAST CANCER PATIENTS.

Sandra Horowitz, Laura Michaud, Jodi Wojdylo and Michelle Gauthier, The

University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard,

Houston, TX 77030.

   It is estimated that 5-10% of women with breast cancer have metastic disease at

the time of diagnosis, and those who do not, approximately 50% will eventually

develop metastases. As metastatic breast cancer is generally considered

incurable, the goals of therapy are to palliate symptoms and improce quality of

life. To this end, a great deal of research has been conducted to find therapies

that preferentially act upon cancer cells while sparring normal tissue.

Trastuzumab (Herceptin) is one of the results of this "targeted therapy"

research. In clinical studies, the use of trastuzumab has been associated with

promising efficacy and relatively minimal toxicity (with the exception of

cardiotoxicity).

   The primary objective of our study is to better characterize the efficacy and

toxicity profile of trastuzumab when given either alone or in combination

regimens, Additionally, we hope to identify variables that may predispose

patients to trastuzumab associated toxicities, in particular, cardiotoxcity, data

will be obtained vie retrospective chart reviews of one hundred and twenty

eligible consecutive patients with metastatic breast cancer who received

trastuzumb at M.D. Anderson Cancer Center between December 1, 1998 and

July 5, 1999.

   Post marketing surveillance is crucial in better characterizing the efficacy and

toxicities associated with trastuzmab. In turn, this information can help to ensure

proper patient selection and appropriate monitoring for trastuzumab therapy.