Fast track for breast cancer drug

The United States Food and Drug Administration (FDA) has granted fast-track designation for Arimadex (anastrozole), which has been in clinical trials for post-menopausal women with early-onset breast cancer. This decision follows quickly after the release of data last month from the ATAC (Arimadex, tamoxifen, alone or in combination) study — the largest adjuvant breast cancer trial ever conducted. The ATAC study involved 9,366 patients with early-onset breast cancer who had completed surgery and chemotherapy and were candidates for adjuvant hormonal therapy. Researchers found that a significantly lower number of women in the Arimadex group had a relapse or died, compared with women who received tamoxifen. Arimadex already has FDA approval for treatment of post-menopausal women with locally advanced or metastatic breast cancer that is oestrogen-receptor positive or of unknown receptor status, and also for treatment of advanced breast cancer that has failed tamoxifen therapy in post-menopausal women. Tamoxifen, which competes with oestradiol for binding to oestrogen receptors, has been used for over 20 years to treat breast cancer. Arimadex has a slightly different mechanism from tamoxifen in that it inhibits oestrogen synthesis. WEB SITE: http://www.astrazeneca-us.com

The good, the bad and the ugly

The results of two chemotherapy trials published in the New England Journal of Medicine bring mixed news for lung cancer patients. First, the good news: in a Phase II trial of 154 patients, Kazumasa Noda and colleagues found that, compared with the current standard of care (etoposide plus cisplatin), combining the topoisomerase I inhibitor irinotecan with cisplatin vastly increased the survival of patients with metastatic small-cell lung cancer — one of the most aggressive forms of cancer. This combination increased the percentage of patients surviving for two years or more from 5.2% to 19.5%.

But the situation is much less clear cut for patients with metastatic non-small-cell lung cancer. Several agents, including gemcitabine, docetaxel and paclitaxel, have shown promising results in combination with a platinum drug (cisplatin or carboplatin), but which combination is the most effective? Joan Schiller and colleagues aimed to find out in a trial of over 1200 patients, but they discovered that all of these therapies give a similar response rate, with a median survival of just 8 months.

In an accompanying editorial, Desmond Carney makes a strong case for giving up on trying to improve chemotherapy regimens, favouring the development of therapies that are based on the biology of the disease, as well as prevention strategies and screening. “The current treatment...is nonspecific, nonselective and toxic. New combinations of chemotherapy are not likely to make substantial improvements in survival”, he says.

ORIGINAL RESEARCH PAPERS Noda, K. et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N. Engl. J. Med. 346, 85–91 (2002) | PubMed | Schiller, J. H. et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N. Engl. J. Med. 346, 92–98 (2002) | PubMed | FURTHER READING Carney, D. N. Lung cancer — time to move on from chemotherapy. N. Engl. J. Med. 346, 126–128 (2002) | PubMed |