Table 2.
Phase III randomized trials of CDK4/6 inhibitors in postmenopausal women with early-stage breast cancer.
| Reference | Trial | Treatment arms | Study sample | Median age | Median follow-up (month) | iDFS | OS | Arthralgia (%) | Myalgia (%) | Bone pain (%) | Back pain (%) | Arthritis (%) | Osteoporosis (%) | Fracture (%) | Carpal tunnel syndrome |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Johnston et al. [35, 38] | MonarchE | Abemaciclib plus endocrine therapy (ET) vs. ET (AIs, tamoxifen) | 5637 (2808/2829) | 51/51 | 15.5 | 2-year: 92.2% vs. 88.7% e (P=0.01; HR: 0.75) | — | 20.5%/31.3% | 5.98%/5.92% | 2.22%/3.32% | 8%/9.7% | 0.32%/1.04% | 1.61%/2.54% | NR | NR |
|
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| Mayer et al. [37] | PALLAS | Palbociclib plus endocrine therapy (ET) vs. ET (AIs, tamoxifen) | 5760 (2883/2877) | 52/52 | 23.7 | 3-year: 88.2% vs. 88.5% (p=0.51; HR: 0.93) | — | 34.9%/41.6% | NR | NR | NR | NR | NR | NR | NR |
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| Loibl et al. [44] | PENELOPE-B | Palbociclib plus endocrine therapy (ET) vs. ET (AIs, tamoxifen) after taxane-containing NACT | 1250 (631/619) | 49/48 | 42.8 | 3-year: 81.2% vs. 77.7% (HR: 0.93; P=0.525) | 3-year: 93.6%/90.5% (HR: 0.87; P=0.420) | 41.2%/46.8% | 20.2%/18.5% | 17.2%/19.1% | 11.2%/13.3% | NR | NR | NR | NR |
NR = not reported; iDFS: invasive disease-free survival; NACT: neoadjuvant chemotherapy.