Table 3.
Key Adverse Events
| Study, Author, Year | Intervention/Comparison | No. of Patients Evaluated | Gynecologic/Endometrial Cancer |
Cardiovascular |
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|---|---|---|---|---|---|---|---|---|---|---|
| VTE/PE |
Stroke |
Ischemic HD |
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| No. | % | No. | % | No. | % | No. | % | |||
| ECOG, Tormey, 1996 | Continue | 100 | 2 ovarian | 2 | ||||||
| Stop (observation) | 93 | 1 ovarian and 1 endometrial | 0 DVT | |||||||
| NSABP B-14, Fisher, 2001 | Continue | 593 (583 for analysis) | 12 | 2.1 | Ischemic HD 6 2 |
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| Stop (placebo) | 579 (569 for analysis) | 6 first events | 1.1 | Other HD 0 1a |
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| Summary statistic | RR = 2.0 | |||||||||
| 95% CI | 0.7 to 6.6b (P NR) | |||||||||
| Scottish Cancer Trials Breast Group, Stewart, 2001 | Continue | 173 | 7/295 (tamoxifen duration > 66 mos) | NR | ||||||
| Stop | 169 f | |||||||||
| ATLAS, Davies, 2012 | Continue | 6,454 | 116 (17 deaths) | 3.1 (0.4% mortality) | 41 | 0.5g | 130 | 127 (178 deaths) | ||
| Stop | 6,440 (12,894c) |
63 (11 deaths) | 1.6 (0.2%) Cumulative risk per year 5-14 |
21 PE PE incidence Years 5-9 0.10 (28/28,307) 0.04 = (11/27,924) Years 10-14 11/16,930 7/16,422e |
0.9 PE PE incidence rates %/yr. |
119 | 163 (205 deaths) Years 10+ RR 0.62 (0.46 to 0.85), P = .02 Ischemic HD By year 5-9 0.23 (65/28,312) 0.24 (67/27,856) RR 0.95 SE 0.17 −1.5/33.0 Years 10-14 0.28 (47/16,948) 0.45 (74/16,280) RR 0.61 SE 0.14 −14.8/30.2 15+ RR 0.66 SE 0.27 −3.9/9.2 |
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| Summary statistic | Incidence ERR 1.74 | ERR 1.87 PE Years 5-9 RR 2.36 Years 10+ RR 1.25 |
ERR 1.06 | ERR 0.76 Incidence all ER Years 5-9 RR 0.95 Years 10+ RR 0.62 ERR 0.85 (death) |
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| 95% CI | 1.30 to 2.34 | ERR 1.13 to 3.07 Years 5-9 RR 1.26 to 4.42 Years 10+ RR 0.55 to 2.83 |
0.83 to 1.36 | ERR 0.60 to 0.96 Years 5-9 RR 0.68 to 1.34 Years 10+ RR 0.46 to 0.85 0.69 to 1.03 (death) |
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| P | < .0012 Incidence ERR Death 0.29 |
ERR 0.01 | 0.63 | ERR 0.02 Years 5-9 RR Years 10+ RR 0.02 0.10 (death) |
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| aTTom, Gray, 2013 | Continue | 6,953 (note 40% ER+, 60% ER unknown) | 102 | 2.9 | NR | |||||
| Stop | 45 cases 37 20 deaths |
1.3 1.1 0.6 deaths |
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| Summary statistic | 2.20 RR cases 1.83 RR deaths |
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| 95% CI | 1.31 to 2.34 RR cases RR 1.09 to 3.09 deaths |
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| P |
P < .0001 (AH 0.5%, 0.02) deaths (source: abstract) |
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Abbreviations: AH, absolute hazard; ATLAS, Adjuvant Tamoxifen Longer Against Shorter; aTTom, Adjuvant Tamoxifen—to Offer More?; DVT, deep vein thrombosis; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; ERR: event rate ratio; HD, heart disease; NSABP, National Surgical Adjuvant Breast and Bowel Project; PE, pulmonary embolism; RR, rate ratio; VTE, venous thromboembolism.
Causes of death as first events.
Summary statistic and/or CI and/or P value not provided.
Regardless of ER status.
Second primary other than breast cancer occurring as 1st events through 10 years post-randomization incidence.
See p 21 of Davies, Lancet, Appendix, 2013.
Second randomization after 5 years of adjuvant tamoxifen.
Events without prior recurrence, any ER status, 48,064 versus 46,959 woman-years of recurrence-free follow-up.