Table 3.
Effectiveness outcomes reported with individual CDK4/6 inhibitors in full-text publications
| References | Region | Patient population | Treatment | Subgroup | Median PFS (95% CI), months | Median OS (95% CI), months | ORR, % |
|---|---|---|---|---|---|---|---|
| 1st line | |||||||
| Agrawal (2021) [62] | Emerging Asia | Pre- and postmenopausal women | P + AI | 1st line (n = 115) | 20.2 (NS) | – | 80.0 |
| Ganguly (2022) [63] | Emerging Asia | Pre- and postmenopausal women | P + AI | NA (n = NS) | 26.0 (16.5–35.0) | 39.9 (23.2–NR) | – |
| R + AI | NA (n = NS) | 12.2 (8.6–22.0) | NR (20.6–NR) | – | |||
| Kahraman (2023) [66] | Turkey | Pre- and postmenopausal women; men | P + L | Women (n = 267) | 21.4 (9.0–33.7) | – | 73.9 |
| R + L | Women (n = 327) | 28.0 (14.5–41. 5) | – | 69.8 | |||
| Lakkavalli (2021) [75] | Emerging Asia | NS | P + ET | NA (n = 26) | NR | – | 57.9 |
| Low (2022) [76] | Emerging Asia | Postmenopausal women | CDK4/6i + ET | 1st line (n = 122) | 28.2 (NS) | – | – |
| Petracci (2020) [53] | Latin America | Pre- and postmenopausal women; men | P + ET | 1st line (n = 63) | 36.7 (18.1–42.6) | NR | 45.3 |
| Queiroz (2023) [68] | Latin America | NS | P + ET | 1st line (n = 37) | 24.0 (8.0–40.0) | – | – |
| R + ET | 1st line (n = 33) | 30.0 (23.5–36.5) | – | – | |||
| A + ET | 1st line (n = 9) | 14.0 (NS) | – | – | |||
| Rath (2021) [77] | Emerging Asia | Premenopausal women; postmenopausal women | CDK4/6i + ET | 1st line (n = 22) | 21.1 (16.3–NR) | NR | – |
| Yıldırım (2022) [78] | Turkey | Men | P + ET | 1st line (n = 9) | NR | – | – |
| R + ET | 1st line (n = 3) | 20.8 (NR) | – | – | |||
| ≥ 2nd line | |||||||
| Agrawal (2021) [62] | Emerging Asia | Pre- and postmenopausal women | P + F | 2nd line (n = 73) | 12.0 (NS) | – | 47.9 |
| Al-Foheidi (2022) [65] | Middle East | Pre- and postmenopausal women | P + ET | Overall (n = 97) | 16.3 (11.4–21.2) | 19.6 (18.1–20.9) | 30.0a |
| Çağlayan (2023) [79] | Turkey | NS | P + ET | Concomitant PPI (n = 29) | 10.6 (7.3–13.8) | – | – |
| P + ET | No PPI (n = 21) | NR | – | – | |||
| R + ET | Concomitant PPI (n = 16) | 13.7 (8.7–18.8) | – | – | |||
| R + ET | No PPI (n = 20) | NR | – | – | |||
| Demir (2020) [64] | Turkey | Pre- and postmenopausal women | P + ET | Overall (n = 43) | 7.0 (4.0–10.0)b | 11.0 (6.0–19.0)b | 13.9 |
| Ganguly (2022) [63] | Emerging Asia | Pre- and postmenopausal women | P + F | NA (n = NS) | 14.2 (3.7–NR) | 16.1 (3.9–NR) | – |
| R + F | NA (n = NS) | 16.5 (3.9–NR) | 18.0 (14.2–NR) | – | |||
| Low (2022) [76] | Emerging Asia | Premenopausal women; postmenopausal women; men | CDK4/6i + ET | 2nd line (n = 119) | 18.4 (NS) | – | – |
| CDK4/6i + ET | 3rd line (n = 70) | 7.7 (NS) | – | – | |||
| CDK4/6i + ET | ≥ 4th line (n = 145) | 9.4 (NS) | – | – | |||
| Petracci (2020) [53] | Latin America | Pre- and postmenopausal women; men | P + ET | ≥ 2nd line (n = 44) | 24.2 (12.0–32.7) | NR | 25.0 |
| Rath (2021) [77] | Emerging Asia | Premenopausal women; postmenopausal women | CDK4/6i + ET | 2nd line (n = 79) | 6.0 (5.0–7. 9) | 20.2 (14.1–NR) | – |
| All lines or line NS | |||||||
| Bruno (2022) [73] | Latin America | Premenopausal women; postmenopausal women | CDK4/6i + ET | BRCA1/2-ATM-CHEK2 mutation (n = 15) | 10.2 (5.7–14.7) | 31.4 (6.6–56.3) | – |
| CDK4/6i + ET | BRCA1/2-ATM-CHEK2 wild type (n = 45) | 15.6 (7.8–23.4) | 49.3 (39.2–59.4) | – | |||
| CDK4/6i + ET | Not tested (n = 157) | 17.6 (12.9–22.2) | – | – | |||
| Dülgar (2022) [56] | Turkey | Premenopausal women; postmenopausal women | CDK4/6i + ET | Overall (n = 80) | – | – | 91.3 |
| CDK4/6i + ET | PSQI score ≤ 5 (n = 25) | – | – | 100.0 | |||
| CDK4/6i + ET | PSQI score > 5 (n = 55) | – | – | 60.0 | |||
| Eser (2022) [80] | Turkey | Pre- and postmenopausal women | P + ET | Concomitant PPI (n = 65) | 13.0c (NS) | – | – |
| P + ET | No PPI (n = 40) | NR | – | – | |||
| R + ET | Concomitant PPI (n = 61) | 12.6c (NS) | – | – | |||
| R + ET | No PPI (n = 51) | NR | – | – | |||
| Ganguly (2022) [63] | Emerging Asia | Pre- and postmenopausal women | CDK4/6i + ET | Overall (n = 144) | 16.5 (11.6–25.5) | 29.7 (21.7–44.6) | 60.0 |
| Keskinkilic (2023) [81] | Turkey | Pre- and postmenopausal women; men | P + ET | Overall (n = 58) | – | – | 47.9 |
| R + ET | Overall (n = 48) | – | – | 37.9 | |||
| Odabas (2023) [82] | Turkey | Postmenopausal women | P + ET | Overall (n = 120) | 15.7 (13.2–18.3) | – | 63.3 |
| R + ET | Overall (n = 100) | 20.3 (16.0–24.2) | – | 69.0 | |||
| Petracci (2020) [53] | Latin America | Pre- and postmenopausal women; men | P + ET | Overall (n = 107) | 29.6 (19.5–38.8) | NR | 45.8 |
| P + AI | NA (n = 68) | 29.6 (18.1–42.6) | NS | – | |||
| P + F | NA (n = 39) | 32.7 (9.3–33.4) | NS | – | |||
| Queiroz (2023) [68] | Latin America | NS | P + ET | NA (n = 79) | 14.0 (4.2–23.8) | – | 62.0 |
| R + ET | NA (n = 42) | 28.0 (13.1–42.9) | – | 76.2 | |||
| A + ET | NA (n = 21) | 6.0 (3.8–8.2) | – | 42.9 | |||
| Rath (2021) [77] | Emerging Asia | Premenopausal women; postmenopausal women | CDK4/6i + ET | Overall (n = 101) | 7.7 (5.52–11.9) | 27.1 (21.9–NR) | 52.5 |
| Yıldırım (2022) [78] | Turkey | Men | CDK4/6i + ET | Overall (n = 25) | – | NR | 60.0 |
| P + ET | NA (n = 9) | 20.6 (13.7–27.5) | – | – | |||
| R + ET | NA (n = 16) | 11.9 (3.9–20.0) | – | – | |||
A abemaciclib, AI aromatase inhibitor, BMI body mass index, CDK4/6i cyclin-dependent kinase 4/6 inhibitor, CI confidence interval, ET endocrine therapy, F fulvestrant, HER2 human epidermal growth factor receptor 2, HR hormone receptor, IHC immunohistochemistry, L letrozole, NA not applicable, NR not reached, NS not specified, OS overall survival, P palbociclib, PFS progression-free survival, PPI proton pump inhibitor, R ribociclib, SD standard deviation
an = 86
bInterquartile range
cThe nature of the central measure was not specified