Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Data Source
2.2. Regimens and Line of Therapy
2.3. Outcomes
2.3.1. Clinical Characteristics
2.3.2. Treatment Patterns
2.3.3. Effectiveness Outcomes
2.4. Statistical Analyses
3. Results
3.1. Patients
3.2. Treatment Patterns
3.3. Clinical Effectiveness
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | n (%) |
---|---|
Sex | |
Female | 238 (98.3) |
Male | 4 (1.7) |
Race | |
White | 196 (81.0) |
Black or African American | 29 (12.0) |
Asian | 10 (4.1) |
Other or not provided | 7 (2.9) |
Ethnicity | |
Hispanic-Latino | 15 (6.2) |
Non-Hispanic/Non-Latino | 225 (93.0) |
Unknown | 2 (0.8) |
Region of residence | |
Midwest | 230 (95.0) |
South | 10 (4.1) |
Other | 2 (0.8) |
Age at A/MBC diagnosis, y | |
Median (min, max) | 66.0 (31.0–93.0) |
50 | 25 (10.3) |
50–64 | 86 (35.5) |
65–74 | 80 (33.1) |
75 | 51 (21.1) |
Menopausal status at A/MBC diagnosis | |
Postmenopausal | 207 (85.5) |
Pre/perimenopausal | 26 (10.7) |
Unknown/not applicable * | 9 (3.7) |
Insurance carrier | |
Medicare/Medicaid | 149 (61.6) |
Commercial | 69 (28.5) |
None/Not stated | 24 (9.9) |
Characteristic | n (%) |
---|---|
A/MBC at diagnosis | 137 (56.6) |
Early stage at diagnosis | 105 (43.4) |
Setting where first-line palbociclib plus AI was received | |
Advanced Setting | 6 (2.5) |
Metastatic Setting | 236 (97.5) |
ECOG PS | |
0 | 57 (23.6) |
1 | 58 (24.0) |
≥2 | 29 (12.0) |
Unknown | 98 (40.5) |
CCI Score | |
0 | 158 (65.3) |
1 | 47 (19.4) |
2 | 22 (9.1) |
3 | 9 (3.7) |
≥4 | 6 (2.5) |
Specific comorbidities | |
Hypertension | 118 (48.8) |
Diabetes | 53 (21.9) |
Renal disease | 22 (9.1) |
Chronic pulmonary disease | 14 (5.8) |
None | 89 (36.8) |
DFI * in patients with early stage disease at diagnosis, mo (n = 105) | |
12 | 14 (13.3) |
13–24 | 12 (11.4) |
25–36 | 10 (9.5) |
36 | 69 (65.7) |
Number of metastatic sites † | |
0 | 1 (0.4) ‡ |
1 | 147 (60.7) |
2 | 45 (18.6) |
≥3 | 49 (20.2) |
Sites of distant metastases § | |
Bone (bone only or in addition to other sites) | 201 (83.1) |
Bone only | 123 (50.8) |
Visceral || | 78 (32.2) |
Lung | 52 (21.5) |
Brain | 6 (2.5) |
Distant lymph nodes | 45 (18.6) |
Liver | 24 (9.9) |
Malignant pleural effusion | 25 (10.3) |
BRCA 1/2 tested | |
Yes | 46 (19.0) |
No | 196 (81.0) |
Dosing Information | n (%) |
---|---|
Starting dose, mg | |
125 | 217 (89.7) |
100 | 18 (7.4) |
75 | 3 (1.7) |
Unknown | 4 (1.2) |
End dose, mg | |
125 | 147 (60.7) |
100 | 67 (27.7) |
75 | 24 (9.9) |
Unknown | 4 (1.7) |
Dose adjustment | |
None | 162 (66.9) |
Decrease | 75 (31.0) |
Increase | 1 (0.4) |
Unknown | 4 (1.7) |
Treatment ongoing | |
Yes | 106 (43.8) |
No | 136 (56.2) |
Discontinuation reason | |
Progression | 64 (26.4) |
Intolerance/toxicity | 36 (14.9) |
Other * | 36 (14.9) |
Subgroup | n | Median rwPFS (95% CI) |
---|---|---|
Metastatic disease sites | ||
Bone only | 123 | 44.9 (39.4–NE) |
Visceral | 78 | 27.9 (13.8–NE) |
Stage at breast cancer diagnosis | ||
Advanced or metastatic (stages IIIb, IIIc, IV) | 137 | 38.8 (26.5–NE) |
Metastatic (stage IV) | 134 | 38.8 (24.4-NE) |
Early stage (stages 0, I, II, IIIa) | 89 | 30.5 (17.4–NE) |
Unknown | 16 | 29.8 (23.9–NE) |
Age at A/MBC diagnosis, y | ||
50 | 25 | NR (13.3–NE) |
50–64 | 86 | 26.5 (17.4–NE) |
65–74 | 80 | 41.9 (29.8–NE) |
≥75 | 51 | 35.8 (21.2–NE) |
ECOG PS | ||
0 | 57 | 29.8 (27.9–NE) |
1 | 58 | 31.7 (19.4–NE) |
2+ | 29 | 13.8 (5.7–NE) |
Unknown | 98 | 38.8 (30.5–NE) |
CCI score | ||
0 | 158 | 44.9 (28.0–NE) |
1 | 47 | 26.5 (13.3–NE) |
2+ | 37 | 29.8 (21.2–NE) |
DFI among patients with early stage disease at diagnosis, mo | ||
≤12 | 14 | 13.3 (3.7–NE) |
12 | 91 | 31.6 (23.9–NE) |
Race | ||
White | 196 | 35.8 (24.4–NE) |
Black or African American | 29 | 18.5 (13.8–NE) |
Number of metastatic sites * | ||
1 | 147 | 44.9 (29.6–NE) |
2 | 45 | 31.6 (14.0–NE) |
≥3 | 49 | 14.7 (12.3–NE) |
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Law, J.W.; Mitra, D.; Kaplan, H.G.; Alfred, T.; Brufsky, A.M.; Emir, B.; McCracken, H.; Liu, X.; Broome, R.G.; Zhang, C.; et al. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Curr. Oncol. 2022, 29, 1047-1061. https://doi.org/10.3390/curroncol29020089
Law JW, Mitra D, Kaplan HG, Alfred T, Brufsky AM, Emir B, McCracken H, Liu X, Broome RG, Zhang C, et al. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Current Oncology. 2022; 29(2):1047-1061. https://doi.org/10.3390/curroncol29020089
Chicago/Turabian StyleLaw, Jeanna Wallenta, Debanjali Mitra, Henry G. Kaplan, Tamuno Alfred, Adam M. Brufsky, Birol Emir, Haley McCracken, Xianchen Liu, Ronda G. Broome, Chenan Zhang, and et al. 2022. "Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network" Current Oncology 29, no. 2: 1047-1061. https://doi.org/10.3390/curroncol29020089