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CMAJ : Canadian Medical Association Journal logoLink to CMAJ : Canadian Medical Association Journal
. 2003 Jan 7;168(1):13.

Weighing the risks and benefits of tamoxifen

Mitchell Gail 1
PMCID: PMC139304

My colleagues and I have shown how to compare the risks and benefits of tamoxifen by combining 3 ingredients:1 the absolute risks of breast cancer and other endpoints, such as stroke, in the absence of tamoxifen; the effects of tamoxifen on these background risks (from data in Fisher and associates2); and weights for comparing the various outcomes. We used weights of 1.0 for life-threatening outcomes (invasive breast cancer, stroke, pulmonary embolism, hip fracture and endometrial cancer), 0.5 for severe outcomes (in situ breast cancer, deep vein thrombosis) and 0 for other events. We pointed out, however, that a woman's own preferred weights could be used. Tables 10 to 12 in Gail and colleagues1 indicate that the risks of tamoxifen outweigh the benefits in many women, especially older women in whom the risks from stroke and endometrial cancer are appreciable. Indeed, Rockhill and collaborators3 estimated that only 2.3% of women in the Nurses' Health Study would experience a net benefit, according to Tables 10 and 11 in our study.1 These observations reinforce the warnings outlined by Eric Wooltorton.4

Greiver suggests that the findings of Gail and colleagues1 be incorporated into a computer-based tool. Until such a program, properly validated, is available, Tables 10 to 12 in that article provide useful indications of net risk or benefit.1

References

  • 1.Gail MH, Costantino JP, Bryant J, Croyle R, Freedman L, Helzlsouer K, et al. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999; 91:1829-46. [DOI] [PubMed]
  • 2.Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998; 90:1371-88. [DOI] [PubMed]
  • 3.Rockhill B, Spiegelman D, Byrne C, Hunter DJ, Colditz GA. Validation of the Gail et al. model of breast cancer risk prediction and implications for chemoprevention. J Natl Cancer Inst 2001; 93: 358-66. [DOI] [PubMed]
  • 4.Wooltorton E. Tamoxifen for breast cancer prevention: safety warning. CMAJ 2002;167(4):378-9. [PMC free article] [PubMed]

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