Table 2.

HR-QoL outcomes in randomized/multi-arm clinical trials testing CDK4/6i in BC patients

Trial name	Population	Questionnaires compliance rate	Outcomes better in CDK4/6i arm	Outcomes comparable in CDK4/6i and control arm	Outcomes better in control arm	Ref
MONARCH-3	Total population	≥ 96% At baseline, ≥88% during treatment, ≥ 70% at follow-up		GHS	Diarrhea scores Nausea/vomiting Appetite loss	18
	Japanese subpopulation	NR	Financial difficulties	GHS	Diarrhea	21
MONARCH-2	Total population	≥ 95% At baseline, ≥85% during treatment, ≥ 77% at follow-up	TTD of pain scores	GHS	Diarrhea scores Nausea/vomiting Appetite loss	19
	Japanese subpopulation	NR	Role functioning	GHS	Diarrhea	22
monarcHER	Total population	100% At baseline, ≥90% during treatment, ≥ 70% at follow-up	TTD in physical and emotional functioning	GHS	Diarrhea	17
monarchE	Total population	≥90% Both arms		GHS/QoL		23
PALOMA-1	Total population	95%		BPI GHS/QoL		29
PALOMA-2	Total population	96%-100% both arms	Pain scores; TTD of GHS	GHS/QoL		25,26
	Asian subpopulation	90%-100% both arms		FACT-B/FACT-G total scores EQ-5D GHS/QoL		27
PALOMA-3	Total population	>96.9 Exp arm >95.8 control arm	Pain scores GHS/QoL TTD		Hair loss	32
	Asian subpopulation	>90% Both arms	Dyspnea	GHS/QoL		33
PALOMA-2, 3	Pooled ≥65 years subpopulation	NR	Pain scores	GHS/QoL		28
PEARL	Total population	>82% Both arms	TTD	GHS/QoL		36
YOUNG PEARL	Total population	NR	Appetite loss	EORTC QLQ-C30 global health status/QoL	Insomnia	37
PALLAS	Total population	NR		GHS/QoL		40
PENELOPE-B	Total population	73.9%		Physical, cognitive and emotional fatigue GHS/QoL		41
MONALEESA-2	Total population	97.0% Exp arm 97.9% control arm	Pain scores	EORTC QLQ-C30 GHS/QoL TTD by ≥10% in overall HR-QoL		46,47
	US subpopulation	99% Exp arm 98% control arm	Pain scores	EORTC QLQ-C30 GHS/QoL TTD by ≥10% in overall HR-QoL		49
	≥65 Years subpopulation	NR	Pain scores	EORTC QLQ-C30 GHS/QoL TTD by ≥10% in overall HR-QoL		48
MONALEESA-3	Total population	92.1% Exp arm 93.4% control arm	TTD ≥10% in overall HR-QoL TTD ≥10% in EORTC QLQ-C30 functioning scores	EORTC QLQ-C30 GHS/QoL		54
MONALEESA-7	Total population	>90% Exp arm >83% control arm	TTD ≥10% in overall HR-QoL EORTC QLQ-C30 subdomains (pain fatigue, physical, emotional, social functioning)	Work productivity		50,52,53
	NSAI subpopulation	NR	TTD ≥10% in overall HR-QoL EORTC QLQ-C30 subdomains (pain fatigue, physical, emotional, social functioning)	Work productivity		51
MONALEESA-3, 7	Pooleda	NR	GHS (greater benefit in patients living longer)			55
MONALEESA-2, 3, 7	Pooledb	NR	TTD ≥10% in GHS, pain, emotional functioning scores	GHS/QoL		56
CORALLEEN	Total population	100% Ribociclib 98% chemotherapy	EORTC QLQ-C30 GHS			57

BC, breast cancer; BPI, Brief Pain Inventory; C, cycle; CDK4/6i, cyclin-dependent kinase 4/6 inhibitors; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EQ-5D, EuroQoL five dimensional; FACT-B, Functional Assessment of Cancer Therapy-Breast; FACT-G, Functional Assessment of Cancer Therapy-General; GHS, global health status; HR, Health Related; NR, not reported; NSAI, non-steroidal aromatase inhibitor; QoL, quality of life; TTD, time to deterioration; US, United States.

^aPooled analysis included overall population of the MONALEESA-3 trial and patients treated with ribociclib/placebo plus an NSAI in the MONALEESA-7.

^bPooled analysis included overall population of the MONALEESA-2 study, in patients receiving ribociclib or placebo plus fulvestrant as first-line treatment in the MONALEESA-3 trial and in patients treated with ribociclib/placebo plus an NSAI in the MONALEESA-7 trial.