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| |  SABCS: Herceptin (Trastuzumab) Works in Older Women with Metastatic Breast Cancer By Robert H. Carlson SAN ANTONIO, TX -- December 17, 2001 -- Women with metastatic breast cancer who are over age 60 should be considered for first-line use of Herceptin (trastuzumab) plus chemotherapy because the combination regimen substantially reduces the risk of mortality in that age group, researchers say. Pamela M. Klein, MD, Clinical Scientist at Genentech Inc., the drug’s manufacturer, presented data at the 24th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas, showing that older women who received Herceptin plus chemotherapy had a 36-percent reduction in the risk of mortality, compared with those who had chemotherapy alone. Dr. Klein said the pivotal trial of Herceptin plus chemotherapy versus chemotherapy alone in first-line therapy of metastatic breast cancer demonstrated an improved response rate of 50 percent versus 32 percent, and also showed that Herceptin improved survival. Eligibility for that trial was not restricted by age, therefore, researchers at Genentech Inc., and at the UCLA School of Medicine in Los Angeles, California, have been able to perform this retrospective exploratory analysis to determine the influence of age on clinical benefit. Out of the total of 469 patients enrolled in the pivotal study, 109 (23 percent) were over 60 years of age. Baseline characteristics were similar between patients 60 or younger and the group older than 60 years, except those in the older age group had worse baseline Karnofsky performance scores, higher initial nodal burdens, and more frequent prior exposure to hormonal therapy. On the other hand, they also had less frequent adjuvant exposure to anthracyclines and longer disease-free intervals from adjuvant therapy. Dr. Klein said the addition of Herceptin to chemotherapy in the older women improved response rates from 28 percent to 44 percent, and survival increased from 14 to 19 months. Some toxicities were more evident among the older patients. Cardiac dysfunction among women who took Herceptin plus paclitaxel chemotherapy occurred in 11 percent of the younger group, compared with 21 percent of the over-60 group. But all cardiac dysfunction events in the older group improved to grade 1 with treatment, Dr. Klein said, and Herceptin treatment was not discontinued because of it. The researchers said older patients appeared to have a worse overall outcome compared with the group 60 and younger, which they said was possibly related to adverse baseline characteristics. But older women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer still saw a significant survival benefit with the addition of Herceptin to chemotherapy, the researchers concluded, and they recommended that these patients be considered for this regimen as first-line therapy.
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