Table 3 Incidence of treatment-related serious adverse events in the main adjuvant aromatase inhibitor trials[71]
From: Status of adjuvant endocrine therapy for breast cancer
Study | Arms numberaMSK: % (comparative P value)b | Arms numberaBMD (T-score): % (comparative P value)b | Arms numberaCV events: % (comparative P value) | Arms numberaGynae: % (comparative Pvalue) | Arms numberaHot flashes : % (comparative P value) |
|---|---|---|---|---|---|
ATAC | A versus T 6,241 | A versus T (5 years) 197 | A versus T 6,186 | A versus T (5 years) 6,186 | A versus T (5 years) 6,186 |
|  | Arthralgia: 35.6 versus 29.4 (<0.0001) | LS: −6.1 versus +2.8 (<0.0001) | Ischemic CV event: 4.1 versus 3.4 (0.1) | Gynecologic eventd: 3.0 versus 10.0 (<0.0001) | 35.7 versus 40.9 (<0.0001) |
| Â | Â | Â | Ischemic CerebroV event: 2.0 versus 2.8 (0.03) | Vaginal bleeding. 5.4 versus 10.2 (<0.0001) | Â |
|  | CTS: 3.0 versus 1.0 (<0.0001) | Hip: −7.2 versus +0.7 (<0.0001) | Venous TE event: 2.8 versus 4.5 (0.0004) | Vaginal discharge: 3.5 versus 13.2 (<0.0001) |  |
| Â | Â | Â | DVT event: 1.6 versus 2.4 (0.02) | Reduced libido: 1.0 versus 0.4 (<0.0001) | Â |
| Â | Â | Â | CV deathc: 2.0 versus 2.0 (NR) | Â | Â |
| Â | Â | Â | CerebroV deathc: 0.8 versus 0.9 (NR) | Â | Â |
| Â | Â | Â | Hypercholesterolemia: 9.0 versus 3.0 (<0.0001) | Â | Â |
BIG 1-98 | L versus T 8,028 (4,992)a | NA | L versus T 4,895 | L versus T (6 years) 3,074 | L versus T (6 years) 3,074 |
| Â | Arthralgia: 20.0 versus 13.5 (<0.001) | Â | Cardiac event: 5.5 versus 5.0 (0.48) | Vaginal bleeding: 5.1 versus 9.9 (<0.001) | 37.7 versus 42.9 (NR) |
| Â | Myalgia: 7.1 versus 6.1 (0.19) | Â | CerebroV accident or TIA: 1.4 versus 1.4 (0.90) | Night sweating: 15.6 versus 19.4 (NR) | Â |
| Â | Â | Â | TE event: 2.0 versus 3.8 (<0.001) | Â | Â |
| Â | Â | Â | Hypercholesterolemia: 50.6 versus 24.6 (<0.001) | Â | Â |
TEAM | E versus T 9,779 | E versus T (1 year) 161 | E versus T 9,779 | E versus T (2.75 years) 9,779 | NA |
|  | Arthralgia: 17.9 versus 9.2 (≤0.001) | LS: −2.8 versus +0.5 (0.0008) | Ischemic CV event/MI: 0.8 versus 0.7 (NR) | Endometrial hyperplasia: 0.0 versus 2.0 (<0.0001) |  |
| Â | Â | Â | Â | Vaginal hemorrhage: 1.6 versus 3.1 (<0.0001) | Â |
|  |  | Hip: −2.2 versus +0.4 (0.04) |  |  |  |
| Â | Â | Â | Â | Vaginal discharge: 2.3 versus 6.8 (<0.0001) | Â |
|  |  | FN: +0.3 versus −1.8 (0.414) |  | Vaginal infection: 0.7 versus 2.2 (<0.0001) |  |
MA.17 | L versus placebo 5,187 | L versus placebo 226 | L versus placebo 5,187 | L versus placebo (2.5 years) 5,187 | L versus placebo 5,187 |
|  | Arthralgia: 25.0 versus 21.0 (<0.001) | LS: −5.4 versus −0.7 (0.008) | CV disease: 5.8 versus 5.6 (0.76) | Vaginal bleeding: 6 versus 8 (0.005) | 58 versus 54 (0.003) |
|  | Arthritis: 6.0 versus 5.0 (0.07) | Hip: −3.6 versus −0.7 (0.044) | MI: 0.3 versus 0.4 (NR) Stroke/TIA: 0.7 versus 0.6 (NR) | Vaginal dryness: 6 versus 5 (0.26) |  |
| Â | Myalgia: 15.0 versus 12.0 (0.0041) | Â | TE event: 0.4 versus 0.2 (NR) Hypercholesterolemia: 16 versus 16 (0.79) | Â | Â |