Table 1. Baseline variables and outcomes in MAP.3.
| Variable | Exemestane | Placebo | HR (95% CI) | P value |
|---|---|---|---|---|
| Baseline | ||||
| Number of women | 2,285 | 2,275 | NA | NA |
| Median age (interquartile range), y | 62.5 (38.5–88.2) | 62.4 (37.1–89.9) | NA | NA |
| Breast cancer risk factors | ||||
| 5-year Gail risk >1.66%: n (%) | 929 (40.7) | 905 (39.8) | NA | NA |
| Age ≥60 years: n (%) | 1,114 (48.8) | 1,126 (49.5) | NA | NA |
| Prior history of IEN: n (%) | ||||
| ADH, ALH, LCIS pooled | 185 (8.1) | 188 (8.3) | NA | NA |
| DCIS- treated with mastectomy | 56 (2.5) | 56 (2.5) | NA | NA |
| Bone variables | ||||
| Prior bisphosphonate use: n (%) | 427 (18.7) | 414 (18.2) | NA | NA |
| Current osteoporosis at baseline: n (%) | 303 (13.3) | 293 (12.9) | NA | NA |
| History of clinical fractures: n (%) | 409 (17.9) | 400 (17.6) | NA | NA |
| Outcomes, primary endpoint: n [annual incidence (%)] | ||||
| Invasive breast cancer | 11 (0.19) | 32 (0.55) | (0.18–0.70) | 0.002 |
| Outcomes, secondary endpoints: n [annual incidence (%)] | ||||
| Breast cancer endpoints | ||||
| Invasive BC: ER positive | 7 (0.12) | 27 (0.46) | 0.27 (0.12–0.60) | <0.001 |
| Invasive BC: ER negative | 4 (0.07) | 5 (0.09) | 0.80 (0.21–2.98) | 0.74 |
| DCIS | 9 (0.16) | 14 (0.24) | 0.65 (0.28–1.51) | 0.31 |
| Combined invasive BC + DCIS | 20 (0.35) | 44 (0.77) | 0.47 (0.27–0.79) | 0.004 |
| Combined IEN: ADH, ALH, LCIS | 4 (0.07) | 11 (0.20) | 0.36 (0.11–1.12) | 0.08 |
| Adverse events (assessed in n women) | n = 2,240 | n = 2,248 | ||
| Musculoskeletal | ||||
| Bone: clinical fractures | 149 (6.7) | 143 (6.4) | NA | 0.72 |
| Bone: new osteoporosis | 37 (1.7) | 30 (1.3) | NA | 0.39 |
| Musculoskeletal: arthritis | 247 (11) | 196 (9) | NA | 0.01 |
| Arthralgia | 665 (30) | 606 (27) | NA | 0.04 |
| Myalgia | 147 (7) | 192 (9) | NA | 0.01 |
| Gastrointestinal events | ||||
| Diarrhea | 118 (5) | 75 (3) | NA | 0.002 |
| Nausea | 155 (7) | 122 (5) | NA | 0.04 |
| Cardiovascular | 106 (4.7) | 111 (4.9) | NA | 0.78 |
| Endocrine: hot flashes | 900 (40) | 718 (32) | NA | <0.001 |
| Sexual function: vaginal dryness | 352 (16) | 343 (15) | NA | 0.68 |
| Other cancers | 43 (1.9) | 38 (1.7) | NA | 0.58 |
| SF-36 and MENQOL | ||||
| SF-36: bodily pain | NA | NA | NA | <0.001 |
| MENQOL: vasomotor | NA | NA | NA | <0.001 |
| MENQOL: sexual | NA | NA | NA | 0.01 |
NOTE: Values are from Goss et al. (33) and accompanying Supplementary Materials at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1103507/suppl_file/nejmoa1103507_appendix.pdf
Abbreviations: BC, breast cancer; CI, confidence interval; IEN, intraepithelial neoplasia; NA, not applicable.