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. 2021 Jan 18;13(2):332. doi: 10.3390/cancers13020332

Table 1.

CDK4/6 inhibitors phase 3 trials according to endocrine sensitivity/resistance patients representation and outcome results.

Drug Trial Setting Endocrine Sensitivity/Resistance (%) Efficacy Adverse Events of Interest
De Novo Late Relapse Early Relapse Second Line PFS (Months) OS (Months)
Ribociclib MONALEESA-2 [17] First line 34 64.7 — — RIBO + LET: 25.3
PBO + LET: 16.0
(HR, 0.56; 95% CI, 0.43–0.72; p < 0.001)		 Immature

  • G ¾ neutropenia: 62%

  • Diarrhea: 2.4%;

  • TE: 0.6%;

  • QTcF prolongation: 3.6%
MONALEESA-7 [18] First and second line 40 52.5 — 14 (after CT) RIBO + TAM/NSAI: 23.8 months
PBO + TAM/NSAI: 13.0 months
(HR, 0.55; 95% CI, 0.44–0.69; p < 0.0001)		 HR, 0.712; 95% CI, 0.535–0.948; p = 0.00973

  • G 3/4 neutropenia: 60.6%

  • Diarrhea: 1%

  • TE: NR

  • QTc prolongation: 7%
MONALEESA-3 [19] First and second line 20 29 28 20 RIB + FUL: 20.5 (33.6 in first line)
PBO + FUL: 12.8 (19.2 in first line)
(HR, 0.593; 95% CI, 0.480–0.732; p < 0.001)		 HR, 0.724; 95% CI, 0.568– 0.924; p = 0.00455

  • G 3/4 neutropenia: 53.4%

  • Diarrhea: 0.6%

  • TE: NR

  • QTcF prolongation: 5.6%
Abemaciclib MONARCH-3 [20] First line 41.2 58.8 — — ABE + NSAI: 28.18 months
PBO + NSAI: 14.76 months
(HR, 0.540; 95% CI, 0.418–0.698; p = 0.000002)		 Immature

  • G 3/4 neutropenia: 23.9%

  • Diarrhea: 82.3%

  • TE: 4.9%

  • QTcF prolongation: 0.3%
MONARCH-2 [21] Second line — — 60 38 ABE + FUL: 16.4
PBO + FUL: 9.3
(HR, 0.553; 95% CI, 0.449–0.681; p < 0.001)		 HR, 0.757; 95% CI, 0.606–0.945; p = 0.0137

  • G 3/4 neutropenia: 23.9%

  • Diarrhea: 82.3%

  • TE: 0.9%

  • QTcF prolongation: 0.3%
Palbociclib PALOMA-2 [22] First line 37.6 40.01 — — PAL + LET: 24.8
PBO + LET: 14.5
(HR, 0.58; 95% CI, 0.46–0.72; p <0.001)		 Immature

  • G 3/4 neutropenia: 66.4%

  • Diarrhea: 1.4%

  • TE: 0.9%

  • QTcF prolongation: 0%
PALOMA-3 [23,24,25] Second line — — 21 79 PAL + FUL: 9.5
PBO + FUL: 4.6
(HR, 0.46; 95% CI, 0.36–0.59; p < 0.0001)		 HR, 0.81; 95% CI, 0.64–1.03; p = 0.09

  • G 3/4 neutropenia: 62%

  • Diarrhea: 0%

  • TE: 1.7%

  • QTcF prolongation: <1%

Abbreviations: AE, adverse event; PFS, progression-free survival; HR, hazard ratio; RIBO, ribociclib; LET, letrozole; PBO, placebo; FUL, fulvestrant; PAL, palbociclib; TAM, tamoxifen; NSAI, nonsteroidal aromatase inhibitor; TE, thromboembolic event.