Introduction
Methods
Study protocol
Procedures
Outcome measurement
Statistical analysis
Results
Patient characteristics
No. of patients | Group A (FUL monotherapy) | Group B (combination therapy) | |
---|---|---|---|
158 | 72 | ||
Age (years) | Median (range) | 67 (44–80) | 67 (44–80) |
BMI (kg/m2) | Mean (SD) | 23.9 (4.0) | 23.6 (3.9) |
Previous treatment, n (%) | |||
Endocrine treatment | None | 59 (37.3) | 20 (27.8) |
≤ 1 | 99 (62.7) | 52 (72.2) | |
Chemotherapy | None | 142 (89.9) | 65 (90.3) |
≤ 1 | 16 (10.1) | 7 (9.7) | |
Distant metastasis, n (%) | |||
De novo | 46 (29.1) | 18 (25.0) | |
Metastatic | 112 (70.9) | 54 (75.0) | |
Nuclear grade, n (%) | I | 42 (26.6) | 18 (25.0) |
II | 42 (26.6) | 15 (20.8) | |
III | 15 (9.5) | 8 (11.1) | |
Unknown | 59 (37.3) | 31 (43.1) | |
Status of hormone receptor, n (%) | |||
ER | Positive | 158 (100.0) | 72 (100.0) |
Negative | 0 (0.0) | 0 (0.0) | |
PgR | Positive | 126 (79.7) | 58 (80.6) |
Negative | 32 (20.3) | 14 (19.4) | |
HER2 | Positive | 0 (0.0) | 0 (0.0) |
Negative | 158 (100.0) | 72 (100.0) | |
Visceral metastasis, n (%) | Yes | 82 (51.9) | 38 (52.8) |
No | 76 (48.1) | 34 (47.2) | |
Adjuvant chemotherapy, n (%) | Yes | 66 (41.8) | 33 (45.8) |
No | 41 (25.9) | 18 (25.0) | |
Adjuvant endocrine therapy, n (%) | Yes | 91 (57.6) | 41 (56.9) |
No | 16 (10.1) | 10 (13.9) | |
Radiation therapy for the metastatic site, n (%) | Yes | 31 (19.6) | 11 (15.3) |
No | 127 (80.4) | 61 (84.7) |
Clinical outcomes in group B
No. of patients | Group A (FUL monotherapy) | Group B (combination therapy) | |
---|---|---|---|
158 | 72 | ||
Best overall response, n (%) | CR | 5 (3.2) | 1 (1.4) |
PR | 30 (19.0) | 5 (6.9) | |
SD or non-CR/non-PD | 92 (58.2) | 54 (75.0) | |
PD | 28 (17.7) | 6 (8.3) | |
NE | 1 (0.6) | 6 (8.3) | |
Loss | 2 (1.3) | – | |
Overall response ratea, n (%) [95% CI] | 35 (22.4) [17.1, 28.6] | 6 (8.3) [3.7, 15.8] | |
CR + PR + SD for more than 6 monthsa, n (%) [95% CI] | 92 (59.0) [52.1, 65.6] | 27 (37.5) [28.0, 47.8] |
Clinical outcomes in group A
Safety
N (%) | Group A (FUL monotherapy) | Group B (combination therapy) |
---|---|---|
No. of patients | 158 | 72 |
All AEs | 78 (49.4) | 65 (90.3) |
Treatment-related AEsa | 73 (46.2) | 65 (90.3) |
Grade 3 or 4 AEs | 71 (44.9) | 64 (88.9) |
Treatment-related grade 3 or 4 AEs | 66 (41.8) | 64 (88.9) |
All-cause death related to AEsb | 0 (0.0) | 0 (0.0) |
Treatment-related deathsb | 0 (0.0) | 0 (0.0) |
Serious AEs | 14 (8.9) | 9 (12.5) |
AEs leading to withdrawal from treatmentd | 5 (3.2) | 5 (6.9) |
N (%) | Total | Grade 1a | Grade 2a | Grade 3a | Grade 4a | Grade 5a |
---|---|---|---|---|---|---|
No. of patients | 72 | – | – | – | – | – |
All AEs | 65 (90.3) | 24 (33.3) | 27 (37.5) | 63 (87.5) | 17 (23.6) | 0 (0.0) |
Decreased neutrophil count | 62 (86.1) | 0 (0.0) | 2 (2.8) | 43 (59.7) | 17 (23.6) | 0 (0.0) |
Decreased white blood cell | 50 (69.4) | 0 (0.0) | 13 (18.1) | 36 (50.0) | 1 (1.4) | 0 (0.0) |
Decreased hemoglobin | 25 (34.7) | 12 (16.7) | 10 (13.9) | 3 (4.2) | 0 (0.0) | 0 (0.0) |
Decreased platelet count | 21 (29.2) | 15 (20.8) | 4 (5.6) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Mucositis oral | 14 (19.4) | 7 (9.7) | 5 (6.9) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Alopecia | 6 (8.3) | 5 (6.9) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Infection | 4 (5.6) | 0 (0.0) | 0 (0.0) | 4 (5.6) | 0 (0.0) | 0 (0.0) |
Osteonecrosis of jaw | 3 (4.2) | 0 (0.0) | 0 (0.0) | 3 (4.2) | 0 (0.0) | 0 (0.0) |
Anorexia | 2 (2.8) | 0 (0.0) | 0 (0.0) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Febrile neutropenia | 2 (2.8) | 0 (0.0) | 0 (0.0) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Pain | 2 (2.8) | 0 (0.0) | 0 (0.0) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Pneumonitis | 1 (1.4) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Increased alanine aminotransferase | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Dizziness | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Lower gastrointestinal hemorrhage | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Hepatobiliary disorders and liver dysfunction | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Pleural effusion | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Thromboembolic event | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Malaise | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Respiratory, thoracic, and mediastinal disorders and interstitial pneumonia | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Periodontal disease | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Bullous dermatitis | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |
Vomiting | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) |