Table 1.
Baseline mean scores by treatment arm and within‐treatment group change from baseline for the European Organization for Research and Treatment of Cancer QLQ‐C30 and BR23, and normative scores (range for all scales: 0 to 100)
| Baseline score, mean ± SD | Change from baseline, a LS mean ± SE | Baseline reference values, mean ± SD | |||||
|---|---|---|---|---|---|---|---|
| Abemaciclib b | Placebo b | Abemaciclib b | Placebo b | MBC population c | General population d | General population e | |
| Global health status | 65.0 ± 21.7 | 58.9 ± 22.5 | 0.0 ± 0.8 | 4.3 ± 1.2 | 60.2 ± 25.5 | 64.3 ± 21.8 | 63.9 ± 22.9 |
| QLQ‐C30 functional scales f | |||||||
| Physical | 76.4 ± 20.1 | 73.2 ± 21.9 | −1.0 ± 0.9 | 1.7 ± 1.2 | 81.6 ± 18.7 | 84.3 ± 18.5 | 80.8 ± 25.2 |
| Role | 76.8 ± 27.8 | 71.5 ± 29.3 | −1.4 ± 1.1 | 2.9 ± 1.6 | 67.4 ± 31.1 | 84.1 ± 24.6 | 81.7 ± 28.2 |
| Emotional | 71.1 ± 23.3 | 69.4 ± 23.2 | 4.7 ± 0.9 | 4.0 ± 1.3 | 65.9 ± 24.6 | 71.9 ± 25.3 | 73.3 ± 28.0 |
| Cognitive | 85.3 ± 18.5 | 86.1 ± 19.0 | −4.0 ± 0.9 | −4.0 ± 1.3 | 80.5 ± 23.2 | 84.3 ± 20.9 | 80.9 ± 25.6 |
| Social | 81.3 ± 24.5 | 78.1 ± 27.8 | −0.1 ± 1.0 | 3.3 ± 1.4 | 74.2 ± 28.4 | 85.7 ± 24.6 | 81.6 ± 29.4 |
| QLQ‐C30 symptom scales f | |||||||
| Fatigue | 32.2 ± 22.8 | 38.3 ± 25.6 | 2.4 ± 1.0 | −2.6 ± 1.4 | 36.3 ± 27.0 | 31.7 ± 25.9 | 31.9 ± 27.8 |
| Nausea and vomiting | 7.2 ± 15.7 | 8.1 ± 18.3 | 2.4 ± 0.6 | −0.4 ± 0.9 | 10.3 ± 19.7 | 5.7 ± 14.9 | 10.9 ± 22.6 |
| Pain | 28.7 ± 26.3 | 36.3 ± 30.2 | −4.8 ± 1.0 | −5.7 ± 1.5 | 30.9 ± 29.6 | 25.3 ± 27.9 | 27.5 ± 30.2 |
| Dyspnea | 19.4 ± 25.4 | 21.9 ± 30.0 | 0.9 ± 1.0 | −1.6 ± 1.4 | 20.4 ± 28.2 | 16.3 ± 24.5 | 19.9 ± 28.5 |
| Insomnia | 26.2 ± 26.9 | 32.9 ± 31.1 | −1.7 ± 1.2 | −4.1 ± 1.7 | 33.1 ± 32.6 | 29.3 ± 30.7 | 30.8 ± 33.2 |
| Appetite loss | 17.9 ± 25.5 | 22.4 ± 28.3 | 0.2 ± 1.1 | −3.9 ± 1.6 | 21.7 ± 31.0 | 10.3 ± 21.6 | 14.1 ± 25.3 |
| Constipation | 13.2 ± 22.1 | 13.6 ± 24.5 | −0.8 ± 0.9 | 1.6 ± 1.3 | 19.2 ± 28.8 | 14.1 ± 24.4 | 18.6 ± 28.6 |
| Diarrhea | 8.3 ± 18.5 | 7.3 ± 15.9 | 18.2 ± 1.0 | −0.5 ± 1.5 | 5.8 ± 15.2 | 9.0 ± 20.3 | 13.7 ± 27.1 |
| Financial difficulties | 16.4 ± 26.4 | 18.0 ± 29.2 | −0.7 ± 1.1 | −1.2 ± 1.6 | 18.6 ± 28.6 | 10.9 ± 24.2 | 17.5 ± 30.8 |
| BR23 functional scales f , g | |||||||
| Body image | 81.6 ± 21.4 | 79.8 ± 26.1 | −4.5 ± 1.1 | 0.6 ± 1.6 | 81.9 ± 22.6 | N/A | N/A |
| Sexual functioning | 10.2 ± 17.3 | 7.7 ± 15.7 | −0.2 ± 0.7 | −0.1 ± 1.0 | 19.2 ± 23.2 | N/A | N/A |
| Future perspective | 42.5 ± 32.2 | 41.5 ± 32.8 | 12.7 ± 1.3 | 11.9 ± 1.9 | 47.6 ± 34.1 | N/A | N/A |
| Symptom scales f , g | |||||||
| Systemic therapy side effects | 15.8 ± 13.1 | 18.1 ± 13.5 | 8.3 ± 0.7 | 3.7 ± 1.0 | 15.8 ± 14.3 | N/A | N/A |
| Breast symptoms | 17.9 ± 19.7 | 14.8 ± 17.3 | −6.1 ± 0.7 | −6.1 ± 1.0 | 17.6 ± 16.7 | N/A | N/A |
| Arm symptoms | 21.0 ± 24.7 | 23.5 ± 22.1 | −1.8 ± 0.9 | −2.2 ± 1.3 | 21.0 ± 21.1 | N/A | N/A |
Abbreviations: BR23, Breast Cancer–Specific Quality of Life Questionnaire; LS, least squares; MBC, metastatic breast cancer; N/A, not applicable; QLQ‐C30, Quality of Life Questionnaire Core 30.
Across all postbaseline visits.
Both arms were also treated with a nonsteroidal aromatase inhibitor.
Reference baseline values for patients with recurrent/metastatic breast cancer across all lines of treatment [25].
Reference baseline values for general female population normative data, aged 18 to ≥70, for 11 European Union countries weighted by age, sex, and country, according to the United Nations Department of Economic and Social Affair population distribution statistics for the year 2015 [26].
Reference baseline values for general population (male and female) normative data, aged 18 to ≥70, for the U.S. weighted by individual country weights and sex and age distributions, according to the United Nations Department of Economic and Social Affair population distribution statistics for the year 2015 [26].
For symptoms, higher scores indicate greater symptom burden. For functioning, higher scores indicate better function.
Sexual enjoyment (functional scale) and upset by hair loss (symptom scale) were not analyzed because of small sample size.