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Incorrect Data and Omission of Trial Site and Personnel in: Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial FREE

JAMA. 2007;298(9):973. doi:10.1001/jama.298.9.973.
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Incorrect Data and Omission of Trial Site and Personnel: In the Original Contribution entitled “Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial” published in the June 21, 2006, issue of JAMA (2006;295(23):2727-2741), incorrect data were reported. In Table 2 on page 2731, the risk ratio (RR) for estrogen receptor–positive patients should have been reported as 0.94. In the “Invasive Breast Cancer” panel of Figure 2 on page 2732, the number at risk in the raloxifene group at 36 months should have been reported as 6702. In the “invasive cancer” row of Table 3 on page 2732, the rate per 1000 for tamoxifen should have been reported as 1.99, the difference in rate per 1000 as 0.74, and the RR as 0.63. Also in Table 3, in the “hysterectomy during follow-up” row, the number of events for tamoxifen should have been reported as 221 and for raloxifene as 87, the rate per 1000 for tamoxifen as 12.24 and for raloxifene as 4.72, the difference per 1000 as 7.52, and the RR (95% confidence interval [CI]) as 0.39 [0.30-0.50]). On page 2733, top of column 1, the annual incidence rate for tamoxifen should have been reported as 1.99, the RR for raloxifene as 0.63, and the cumulative incidence rate through 7 years for tamoxifen as 14.6. Also on page 2733, end of first paragraph in column 2, the number of hysterectomies performed in those assigned to tamoxifen should have been reported as 221 and in those assigned to raloxifene as 87, and the RR (95% CI) as 0.39 (0.30-0.50). In the “Invasive Uterine Cancer” panel of Figure 3 on page 2733, numbers at risk in the raloxifene group at 18, 36, 54, and 72 months should have been reported as 4311, 3233, 2103, and 409, respectively; in the tamoxifen group, the numbers at risk at these same points should have been reported as 4301, 3120, 1984, and 371, respectively. In Table 5 on page 2735, the rate per 1000 for ischemic heart disease in the tamoxifen group should have been reported as 2.99 and the difference per 1000 as −0.30. In the first paragraph of the Comment section on page 2736, the terms “raloxifene” and “tamoxifen” were reversed in the second sentence; the sentence should have read “The cumulative incidence rates were 25.1 per 1000 women (tamoxifen) vs 24.8 per 1000 (raloxifene) (P = .83).” Also, a trial site and its personnel were inadvertently omitted: in the list of active NSABP STAR P-2 clinical centers appearing on page 2739, “Boston Medical Center, Boston, Mass: Marianne N. Prout (PI), Liz Pottier (PC);” should have appeared between the entries for Boca Raton Community Hospital and CAMC Health Education and Research Center.

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