Table 1. Characteristics of the included studies.
| Study | Age (yr) | Study drug | Method of evaluation | Timing of evaluation | Inclusion of patients with baseline symptoms | No. of total patients | % of total trial patients | Patients with symptoms, no. (%) | Follow-up duration |
|---|---|---|---|---|---|---|---|---|---|
| Mortimer et al. WHEL trial (2008) [5] | Median, 54 (range, 27–73) | Tamoxifen | Questionnaire for 34-item self report symptom inventory | At enrollment, during the previous 4 wk | Unknown | 864 | 55.7 | VM: 674 (78) | Average 24 mo between diagnosis and study entry, 89 mo after study entry |
| Enrolled 2–48 mo from initial breast cancer diagnosis | |||||||||
| Cuzick et al. ATAC trial (2008) [11] | Mean, 63.9 (SD, 9.0), only postMP | Anastrozole vs. tamoxifen for 5 yr | Elicited responses regarding side-effects (specific symptom checklist not used) | Initial 3-mo follow-up visit | No | 3,964 | 64.1 | All: 2,188 (55.2) | Median, 100 mo (range, 0–126) |
| Only VM: 943 (23.8) | |||||||||
| Only MSK: 702 (17.2) | |||||||||
| Mieog et al. IES study (2012) [8] | PostMP | After tamoxifen for 2–3 yr, tamoxifen vs. exemestane | Case-report forms | At 6 mo after randomization (2.5–3.5 yr after start of endocrine therapy) | Yes | 4,657 | 98.6 | MSK: 1,760 (37.8) | Median, 91 mo (IQR, 83.0–99.2) |
| Fontein et al. TEAM trial (2013) [10] | Median, 63.8 (range, 34.9–96.1), only postMP | Exemestane vs. tamoxifen → exemestane (total 5 yr) | Patients elicited responses during follow-up visits | During the 1st year (evaluation every 3 mo) | Unknown | 9,325 | 95 | All: 4,693 (50.3) | Median, 5.13 yr (range, 0.01–9.23) |
| Only VM: 3,003 (32.2) | |||||||||
| Only MSK: 2,635 (28.3) | |||||||||
| Only VV: 1,150 (12.3) | |||||||||
| Huober et al. BIG 1-98 trial (2014) [9] | Median, 61 (range, 38–88), only postMP | Tamoxifen vs. letrozole | Pre-specified check-boxes for vasomotor symptoms and text field responses for arthralgia/myalgia/carpal tunnel symptoms | 3 and 12 mo after randomization | No | 4,798 | 97.5 | VM, 3 mo: 1,004 (21) | Median, 7 yr |
| MSK, 3 mo: 198 (4) | |||||||||
| VM, 12 mo: 1,488 (32) | |||||||||
| MSK, 12 mo: 508 (11) | |||||||||
| Stearns et al. NCIC CTG MA.27 trial (2015) [7] | PostMP | Exemestane vs. anastrozole | Patient-reported symptoms collected using CTCAE ver 3.0 | At 6 and 12 mo treatment follow-up | Both reported | 5,412* | 74 | VM, 6 mo: 1,001 (17.8) | Median, 4.1 yr |
| Grade 3,4 MSK, 6 mo: 55 (1) | |||||||||
| VM, 12 mo: 1,937 (34.8) | |||||||||
| Grade 3,4 MSK, 12 mo: 112 (2) |
VM=vasomotor symptoms; SD=standard deviation; postMP=postmenopausal; MSK=musculoskeletal symptoms; IQR=interquartile range; VV=vulvovaginal symptoms; CTCAE=Common Terminology Criteria for Adverse Events.
*Patients without baseline vasomotor or grade 3 or 4 joint symptoms.