CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience
Abstract
:1. Introduction
2. Materials and Methods
Statistics
3. Results
3.1. Patients Characteristics
3.2. Survival Analysis
3.3. Association of CDK4/6 Inhibitors with Arthralgia
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A
Clinical Trial | Trial Number | Treatment Arms | Sample Size (Size per Arm) | Median Age | Median Follow-Up | PFS | OS | Arthralgia (%) |
---|---|---|---|---|---|---|---|---|
PALOMA-1 | NCT00721409 | palbociclib plus letrozole vs. letrozole plus placebo | 165 (84/81) | 63/64 | 64.7 | 20.2/10.2 (HR:0.488; p = 0.0004) | 37.5/34.5 (HR: 0.897; p = 0.281) | 27.7/18.2 |
PALOMA-2 | NCT01740427 | palbociclib plus letrozole vs. letrozole plus placebo | 666 (444/222) | 62/61 | 23 | 24.8/14.5 (H: 0.58; p < 0.001) | 42.1/34.7 (p = 0.06) | 33.3/33.8 |
PALOMA-3 | NCT01942135 | palbociclib plus fulvestrant vs. fulvestrant plus placebo | 517 (345/172) | 57/56 | 44.8 | 9.2/3.8 (HR: 0.422; p < 0.0001) | 34.9/28 (HR: 0.81; p = 0.09) | 13/16.3 |
MONALEESA-2 | NCT01958021 | ribociclib plus letrozole vs. placebo plus letrozole | 668 (334/334) | 62/63 | 26.4 | 25.3/16 (HR: 0.568) | 42.5/28.7; H: 0.746 | 27.5/28.8 |
MONALEESA-3 | NCT02422615 | ribociclib plus fulvestrant vs. placebo plus fulvestrant | 726 (484/242) | 63.4/62.8 | 39.4 | 20.5/12.8 (HR: 0.593; p < 0.001) | 57.8%/45.9% at 42 months | 23.8/26.6 |
MONALEESA-7 | NCT02278120 | ribociclib plus tamoxifen/NSAI plus goserelin vs. placebo plus tamoxifen/NSAI plus goserelin | 672 (335/337) | 42.6/43.7 | 19.2 | 23.8 vs. 13 (H: 0·55, p < 0·0001) | NR | 29.85/27.3 |
MONARCHE-2 | NCT02107703 | abemaciclib plus fulvestrant vs. placebo plus fulvestrant | 669 (446/223) | 59.3/61.1 | 19.5 | 16.4/9.3 (HR: 0.553; p < 0.001) | NR | 11.6/14.3 |
MONARCHE-3 | CT02246621 | abemaciclib plus anastrozole or letrozole vs. placebo plus anastrozole or letrozole | 493 (328/165) | 63/63 | 26.8 | 28.2 vs. 14.7; (H: 0.54; p < 0.001) | NR | 17.43/20.5 |
MONARCHE PLUS | NCT02763566 | abemaciclib plus NSAI vs. placebo plus NSAI or abemaciclib plus fulvestrant vs. placebo plus fulvestrant | 463 (207/99/104/53) | 56/59/55/58) | 26 | Not reached vs. 14.7; H: 0.49 | 56/30 (p < 0.0001) | 5.8/13.1 6.7/5.6 |
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Overall Toxicity N (%) | Yes | 29 (61.7) |
---|---|---|
No | 15 (31.9) | |
Not reported | 3 (6.4) | |
Hematological toxicity N (%) | Yes | 24 (51.1) |
No | 20 (42.6) | |
Not reported | 3 (6.4) | |
Type of hematological toxicity N (%) | Neutropenia | 22 (86.8) |
Anemia | 2 (4.3) | |
Neutropenia/thrombocytopenia | 1 (2.1) | |
Neutropenia/leukopenia | 1 (2.1) | |
Arthralgia N (%) | Yes | 3 (6.4) |
No | 42 (89.4) | |
Not reported | 2 (4.3) |
Patient Characteristics | All Patients (47) | |
---|---|---|
Age, median, range | 58 | (29–81) |
Menopausal status, N (%) | Perimenopausal | 6 (12.8) |
Premenopausal | 10 (21.3) | |
Postmenopausal | 31 (66) | |
Stage at initial diagnosis, N (%) | Non-metastatic | 25 (53.2) |
Metastatic | 22 (46.8) | |
Histology, N (%) | IDC | 39 (83) |
ILC | 5 (10.6) | |
Mucinous | 1 (2.1) | |
IDC/ILC | 1 (2.1) | |
Not reported | 1 (2.1) | |
ER status, N (%) | Positive | 45 (95.7) |
Negative | 2 (4.3) | |
PR status, N (%) | Positive | 43 (91.5) |
Negative | 4 (8.5) | |
Grade, N (%) | I | 2 (4.3) |
II | 24 (51.1) | |
III | 18 (38.3) | |
Not reported | 3 (6.4) | |
Adjuvant hormonotherapy, N (%) | Yes | 20 (80) |
No | 4 (16) | |
Not reported | 1 (4) | |
Adjuvant chemotherapy, N (%) | Yes | 23 (92) |
No | 1 (4) | |
Not reported | 1 (4) | |
Adjuvant radiation therapy, N (%) | Yes | 18 (72) |
No | 6 (24) | |
Not reported | 1 (4) | |
Disease progression, N (%) | 20 (42.6) | |
CDK4/6 inhibitor, N (%) | Abemaciclib | 6 (12.7) |
Palbociclib | 30 (63.8) | |
Ribociclib | 11 (23.4) | |
Concomitant treatment, N (%) | Fulvestrant | 16 (34) |
Letrozole | 28 (59.6) | |
Tamoxifen | 3 (6.4) | |
Treatment duration, median, range | 8.76 | 0.47–30.13 |
Dose reduction, N (%) | Yes | 12 (25.5) |
No | 33 (70.2) | |
Not reported | 2 (4.3) | |
Dose interruption, N (%) | Yes | 24 (51.1) |
No | 20 (42.6) | |
Not reported | 3 (6.4) | |
Treatment discontinuation, N (%) | Yes | 18 (38.3) |
No | 27 (57.4) | |
Not reported | 2 (4.3) | |
Reason of discontinuation, N (%) | Hematological toxicity | 2 (4.3) |
Hyperkalemia | 1 (2.1) | |
PD | 16 (34) | |
Disease progression on CDK4/6 inhibitor, N (%) | 16 (34) | |
Progression-free survival (PFS), median, range | 24.3 | 1.71–46.96 |
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Andrikopoulou, A.; Fiste, O.; Apostolidou, K.; Skafida, E.; Markellos, C.; Liontos, M.; Kyriazoglou, A.; Dimopoulos, M.-A.; Zagouri, F. CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience. Med. Sci. 2021, 9, 42. https://doi.org/10.3390/medsci9020042
Andrikopoulou A, Fiste O, Apostolidou K, Skafida E, Markellos C, Liontos M, Kyriazoglou A, Dimopoulos M-A, Zagouri F. CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience. Medical Sciences. 2021; 9(2):42. https://doi.org/10.3390/medsci9020042
Chicago/Turabian StyleAndrikopoulou, Angeliki, Oraianthi Fiste, Kleoniki Apostolidou, Efthymia Skafida, Christos Markellos, Michalis Liontos, Anastasios Kyriazoglou, Meletios-Athanasios Dimopoulos, and Flora Zagouri. 2021. "CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience" Medical Sciences 9, no. 2: 42. https://doi.org/10.3390/medsci9020042