Results of Breast Cancer Drug under Spotlight

By McCann, Jean | Drug Topics, June 21, 1999 | Go to article overview

Results of Breast Cancer Drug under Spotlight


McCann, Jean, Drug Topics


Breast cancer issues hogged the spotlight as the American Society of Clinical Oncology held its latest meeting-19,000 strong-in Atlanta.

Even before the meeting began, word had leaked out that perhaps the use of high-dose chemotherapy for breast cancer, followed by bone marrow transplant, wasn't all it had been cracked up to be. In a large trial of 784 patients, conducted by Cancer & Leukemia Group B (CALGB), William Peters, M.D., reported similar mortality rates at three years with high-dose chemotherapy and stemcell transplant (78%) compared with moderate-dose chemotherapy without transplant (80%).

The one positive study, from South Africa's Witswaterswand University, included only 154 patients, who showed a survival advantage for high-dose chemotherapy at more than five years. Karen Antman, M.D., Columbia University, noted that the African study, which she described as "unequivocally positive," was the only one with a CAF (cyclophosphamide, doxorubicin, and 5-fluorouracil) control arm. Other studies need to mature, she said, but there should be new data soon on the subject from four major European studies. In the meantime, Antman advised that patients continue in studies and that any highdose therapy given off-study be "with truly informed consent."

Wait and see

"Wait and see" appeared to be the word when it came to chemoprevention of breast cancer. The major concern appeared to be not whether chemoprevention with agents like tamoxifen (Nolvadex, Zeneca) for postmenopausal women actually work, but rather for which groups of women they work best, and for how long they should be given.

The first report on the use of raloxifene (Evista, Lilly) was encouraging. In this study in postmenopausal women taking raloxifene, versus placebo, for osteoporosis, the end points were a reduction in breast and endometrial cancer as well as in fractures. After 40 months of follow-up at the 180 centers participating, the risk of estrogen receptor-positive breast cancer in women randomized to the drug, compared with the placebo group, was 0.9, versus the overall risk of breast cancer of 0.24, a "strongly significant" 75% reduction. There was no increased risk of endometrial cancer with raloxifene.

The risk of thromboembolic disease was similar to that seen with estrogen and tamoxifen, J. Cauley, M.D., of the University of Pitts burgh, said. Raloxifene, unlike tamoxifen, is approved only for prevention of osteoporosis. The upcoming STAR (Study of Tamoxifen and Raloxifene) trial, which expects to enroll 22,000 women, will compare tamoxifen and raloxifene as breast cancer prevention agents.

In an earlier talk about the NSABP (National Surgical Adjuvant Breast & Bowel Project) P1 prevention trial, Donald Wickerham, M.D., noted that the use of tamoxifen halved the risk of breast cancer after five years in women at high risk because they had had lobular carcinoma in situ or had biopsies showing atypical hyperplasia-both risk factors for the development of invasive breast cancer.

In his comment at the end of the session, Bernard Fisher, M.D., who earlier had received a special award for his 40 years of work in making large-scale clinical trials in breast cancer possible, alluded to criticisms about giving agents like tamoxifen to allegedly healthy women to prevent breast cancer. He reminded the audience that "many women owed their lives to chemotherapy before every last question was answered."

There was an encouraging report about a third-generation aromatase inhibitor-a further approach to treating breast cancer. In a phase III trial of 769 postmenopausal women whose cancers had spread despite tamoxifen, investigational exemestane tablets (Aromasin, Pharmacia & Upjohn) showed superior activity over megestrol acetate (Megace, Bristol-Myers Squibb). …

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