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. 2022 Nov 16;7(6):100629. doi: 10.1016/j.esmoop.2022.100629

Table 3.

HR-QoL from CDK4/6 inhibitors real-world experiences in BC patients

Author (year) Intervention Setting N Evaluation tools Evaluation timepoints HR-QoL outcomes Ref
Loi (2021) Palbociclib + letrozole Advanced 252 EQ-5D Baseline, every cycle, EoT No significant changes in GHS from baseline 59
Rahman (2022) Palbociclib + letrozole Advanced 88 FACIT-F Screening, baseline, third week for 6 cycles 24% New-onset fatigue during treatment; 15% severe fatigue 63
Richardson (2021) Palbociclib + ET Advanced 139 SF-12,
CES-D-10, targeted questions
Baseline, different evaluations on daily, weekly and monthly base for 6 months No significant changes in GHS from baseline; low depression incidence 62
Rocque (2020) Palbociclib + ET Advanced 522 EORTC QLQ-C30 Baseline, q3 months, EoT No significant changes in GHS status from baseline; trend towards pain improvement 60
Rocque (2021)a Palbociclib + ET Advanced 233 EORTC QLQ-C30 Baseline, q3 months, EoT No significant changes in GHS from baseline 61
Stearns (2018) Palbociclib + letrozole Advanced 334 EQ-5D Baseline, every cycle, EoT No significant changes in GHS from baseline 58
Oswald (2021) CDK4/6 inhibitor + ET Advanced 20 FACT-B,
FACT-G,
FACIT-F,
BCPT,
NEQ
1-Time evaluation HR-QoL scores 104.8 (SD 18.4) with the FACT-B and 80.3 (SD 12.5) with the FACT-G; mean fatigue score 33.8 (SD 12.1);
patients slightly to moderately bothered at the BCPT symptoms scale;
2.8 average unmet needs at the NEQ
64

BC, breast cancer; BCPT, Breast Cancer Prevention Trial; BPI-sf, Brief Pain Inventory-short form; CDK4/6, cyclin-dependent kinase 4/6; CES-D-10, Center for Epidemiological Studies Depression Scale; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EoT, end of treatment; EQ-5D, EuroQoL five dimensional; ET, endocrine treatment; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FACT-B, Functional Assessment of Cancer Therapy-Breast; FACT-G, Functional Assessment of Cancer Therapy-General; HR-QoL, health-related quality of life; GHS, global health status; NEQ, Needs Evaluation Questionnaire; SD, standard deviation; SF-12, Short Form-12.

a

Black, indigenous and people of color subpopulation of the POLARIS study (interim analysis of total population reported by Rocque et al.60 in 2020).