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Home: Oncology Leader Commentary: Richard Margolese, MD

Click on the topic below for comments by Dr Richard Margolese to comment on. You will also find links to related articles and clinical trials.

Surgery and breast cancer
Philosophy of DCIS management
Excision alone for DCIS
DCIS subsets
Margins and DCIS
Is DCIS a surgical disease?
Tamoxifen for DCIS
NSABP DCIS trials
Tamoxifen: Prevention or delay of clinical onset of disease
Risk-benefits of tamoxifen for DCIS
Tamoxifen and venous thrombosis
Duration of preventive effect of tamoxifen
Mortality effects of tamoxifen in high-risk women
Raloxifene as chemoprevention

Mortality effects of tamoxifen in high-risk women

Interview with Neil Love, MD from Breast Cancer Update for Surgeons, Program 1 2000

Play Audio Below:

Supposing that there is no mortality benefit, does that mean it’s not worth it for a woman not to get cancer? That’s absurd! Because if she gets cancer she’s got a risk of dying, that’s true, but even if she is not going to die she’s going to go through a lot and her life will be changed, so I think it’s worth preventing cancer. I think we’ll never get the answer to the mortality question simply because the trial was never designed that way. And it’s interesting that the critics of the trial who, after the results were published, continued to criticize — they just looked for different things to criticize — and instead of criticizing the use of tamoxifen, they now mention things like this. Well, when this trial was started and women were enrolled, those women we’re told that any new findings apropos to their participation would certainly be made known to them. One of the findings that must be made known to them is the discovery that tamoxifen does what we hoped it would do; it inhibits 50% of the breast cancers. And when we got to the statistically pre-determined number of events that triggered the analysis, the analysis showed that this was the outcome. That’s the end of the trial. The trial was not stopped prematurely, the trial doesn’t have a time frame in its design. The trial has an endpoint of 47% reduction in the rate of cancer. We passed that; actually we got 49% of the first analysis, and that’s the end of the trial. It happened sooner for a very simple reason: There were more participants with higher risk than we anticipated. In other words, the average participant in this trial had a slightly higher risk of breast cancer than we thought they would have. That’s just who comes forward.

Relevant Articles:

Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women
Smith, T. J. and Hillner, B. E.. Journal of Clinical Oncology. 18(2):284-286, 2000 Jan.

Estimation of tamoxifen's efficacy for preventing the formation and growth of breast tumors.
Radmacher, M.D., Simon, R. -- (Reprint available from: Radmacher MD NIH 7550 Wisconsin Ave,MS 9015 Bethesda, MD 20892 USA).. Journal of the National Cancer Institute. 92(1):48-53, 2000 Jan 5.

Tamoxifen and risk of contralateral breast cancer in BRCA1 and BRCA2 mutation carriers: a case-control study
Narod, S. A.; Brunet, J. S.; Ghadirian, P.; Robson, M.; Heimdal, K.; Neuhausen, S. L.; Stoppa-Lyonnet, D.; Lerman, C.; Pasini, B.; de los Rios, P.; Weber, B., and Lynch, H.. Lancet. 356(9245):1876-1881, 2000 Dec 2.

Chemoprevention options for BRCA1 and BRCA2 mutation carriers.
Eeles, R. A. and Powles, T. J. Journal of Clinical Oncology. 18(21 Suppl S):93S-99S, 2000 Nov 1.

Chemoprevention of breast cancer [Review].
Brown, P. H. and Lippman, S. M. (Reprint available from: Lippman SM Univ Texas, MD Anderson Canc Ctr, Dept Clin Canc Prevent 1515 Holcombe Blvd,Box 236 Houston, TX 77030 USA). Breast Cancer Research & Treatment. 62(1):1-17, 2000 Jul.

Hormonal approaches to the chemoprevention of endocrine-dependent tumors.
Manni, A.. Endocrine-Related Cancer. 6(4):483-485, 1999 Dec.

Pilot trial of the safety, tolerability, and retinoid levels of N-(4-hydroxyphenyl) retinamide in combination with tamoxifen in patients at high risk for developing invasive breast cancer.
Conley, B.; O'Shaughnessy, J.; Prindiville, S.; Lawrence, J.; Chow, C.; Jones, E.; Merino, M. J.; Kaiser-Kupfer, M. I.; Caruso, R. C.; Podger, M.; Goldspiel, B.; Venzon, D.; Danforth, D.; Wu, S. L.; Noone, M.; Goldstein, J.; Cowan, K. H., and Zujewski, J.. Journal of Clinical Oncology. 18(2):275-283, 2000 Jan.

Vitamin A analogue for breast cancer prevention: a grade of F or incomplete? Response
Piantadosi, S. (Reprint available from: Piantadosi S Johns Hopkins Univ, Sch Med, Johns Hopkins Oncol Ctr 550 N Broadway,Suite 1103 Baltimore, MD 21205 USA).. Journal of the National Cancer Institute. 92(3):274-275, 2000 Feb 2. No abstract

Tamoxifen for the prevention of breast cancer in the high-risk woman.
Morrow, M. and Jordan, V. C. (Reprint available from: Morrow M 676 N St Clair St,13th Floor, Room 13-104 Chicago, IL 60611 USA).. Annals of Surgical Oncology. 7(1):67-71, 2000 Jan-Feb. No abstract

Relevant Clinical Trials:

Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer

Randomized, Double-Blind, Placebo-Controlled Study of Tamoxifen for the Prevention of Breast Cancer in High-Risk Women: International Breast Cancer Intervention Study

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