Article Figures & Data
Figures
- Figure 1
Waterfall plot of the best percentage change in target lesion size.
- Figure 2
Kaplan-Meier graph showing progression-free survival. (A) The median progression-free survival (PFS) of all patients (n = 26) was 5.22 months. (B) The median PFS of hormone receptor-positive (n = 16) and hormone receptor-negative (n = 10) patients was 5.88 months and 4.04 months, respectively, HR = 0.62, 95% CI (0.24–1.63), P = 0.32.
- Figure 3
Distribution of the top 25 genomic alterations in the entire population at baseline.
Tables
Characteristics Anlotinib Total (n = 26) Hormone receptor positive (n = 16) Hormone receptor negative (n = 10) Age, median (range) 56 (30–75) 56 (30–75) 50 (32–64) Age (years), n (%) ≥ 65 3 (11.54) 3 (18.75) 0 < 65 23 (88.46) 13 (81.25) 10 (100) ECOG, n (%) 0 7 (26.92) 5 (31.25) 2 (20.00) 1 16 (61.54) 10 (62.50) 6 (60.00) 2 3 (11.54) 1 (6.25) 2 (20.00) Hormone receptor, n (%) Positive 16 (61.54) 16 (100) 0 Negative 10 (38.46) 0 10 (100) Type of metastatic site, n (%) Non-visceral 4 (15.38) 2 (12.50) 2 (20.00) Visceral 22 (84.62) 14 (87.50) 8 (80.00) Number of metastatic sites, n (%) 1 3 (11.54) 2 (12.50) 1 (10.00) 2 12 (46.15) 7 (43.75) 5 (50.00) ≥ 3 11 (42.31) 7 (43.75) 4 (40.00) Metastatic site, n (%) Lymph nodes 13 (50.00) 7 (43.75) 6 (60.00) Liver 9 (34.62) 8 (50.00) 1 (10.00) Lung 17 (65.38) 9 (56.25) 8 (80.00) Pleural effusion 6 (23.08) 3 (18.75) 3 (30.00) Chest wall 2 (7.69) 1 (6.25) 1 (10.00) Pericardial effusion 2 (7.69) 0 2 (20.00) Bone 15 (57.69) 12 (75.00) 3 (30.00) Neoadjuvant, n (%) Yes 3 (11.54) 1 (6.25) 2 (20.00) No 23 (88.46) 15 (93.75) 8 (80.00) Adjuvant chemotherapy, n (%) Yes 23 (88.46) 15 (93.75) 10 (100) No 3 (11.54) 1 (6.25) 0 Adjuvant endocrine therapy, n (%) Yes 16 (61.54) 16 (100) 0 No 10 (38.46) 0 10 (100) Previous lines of systematic treatment, n (%) ≤ 2 14 (53.85) 8 (50.00) 6 (60.00) ≥ 3 12 (46.15) 8 (50.00) 4 (40.00) Type of previous endocrine therapy combined with target therapy, n (%) Both CDK/4/6 inhibitor and mTOR inhibitor 3 (11.54) 3 3 (18.75) 0 Only CDK4/6 inhibitor 2 (7.69) 2 (12.50) 0 Only mTOR inhibitor 2 (7.69) 2 (12.50) 0 Previous chemotherapy after metastasis, n (%) Taxanes 26 (100) 16 (100) 10 (100) Fluorouracil† 22 (84.62) 12 (75.00) 10 (100) Platinum 10 (38.46) 3 (18.75) 7 (70.00) Others‡ 17 (65.38) 10 (62.50) 7 (70.00) ECOG, Eastern Cooperative Oncology Group.†Including capecitabine and S-1. ‡Other drugs, including gemcitabine, vinorelbine, and etoposide.
Total Hormone receptor positive Hormone receptor negative Statistics Numbers 26 16 10 ORR (%) 15.38 18.75 10 95% CI (4.36–34.87) (4.05–45.65) (0.25–44.50) P = 1.00† DCR (%) 80.77 87.5 70 95% CI (60.65–93.45) (61.65–98.45) (34.75–93.33) P = 0.34‡ Numbers censoring, n (%) 8 (30.77) 6 (37.50) 2 (20.00) Median PFS 5.22 5.88 4.04 95% CI (2.86–6.24) (1.94–8.87) (1.87–6.24) HR§ – – – 0.62, χ2 = 0.9595 95% CI§ – – – (0.24–1.63), P = 0.32 PFS, progression-free survival; CI, confidence interval; HR, hazard ratio; ORR, objective response rate; DCR, disease control rate.†The ORR/DCR comparison between groups (positive vs. triple negative) was analyzed with Fisher’s exact test. ‡The 95% CI of the ORR/DCR was calculated with the Clopper-Pearson method. §The comparison of progression-free survival between 2 groups (hormone receptor positive vs. hormone receptor negative) was performed with a log-rank test. The HR and 95% CI (hormone receptor positive vs. hormone receptor negative) were estimated with the Cox proportional-hazards model.
Adverse events All grades, n (%) Grade 1, n (%) Grade 2, n (%) Grades 3–4, n (%) Fatigue 4 (15.38) 3 (11.54) 1 (3.85) 0 (0) Anorexia 2 (7.69) 0 (0) 2 (7.69) 0 (0) Weight loss 1 (3.85) 1 (3.85) 0 (0) 0 (0) Pharyngalgia 3 (11.54) 3 (11.54) 0 (0) 0 (0) Mucositis oral 1 (3.85) 1 (3.85) 0 (0) 0 (0) Cough 2 (7.69) 2 (7.69) 0 (0) 0 (0) Hand-foot syndrome 6 (23.08) 5 (19.23) 0 (0) 1 (3.85) Urinary tract infection 1 (3.85) 0 (0) 1 (3.85) 0 (0) Hematuria 2 (7.69) 2 (7.69) 0 (0) 0 (0) Proteinuria 4 (15.38) 4 (15.38) 0 (0) 0 (0) Hypertension 15 (57.69) 4 (15.38) 4 (15.38) 7 (26.92) TSH elevation 9 (34.62) 9 (34.62) 0 (0) 0 (0) Hypothyroidism 2 (7.69) 2 (7.69) 0 (0) 0 (0) Hypertriglyceridemia 1 (3.85) 1 (3.85) 0 (0) 0 (0) Hypercholesterolemia 1 (3.85) 1 (3.85) 0 (0) 0 (0) LDL elevation 2 (7.69) 2 (7.69) 0 (0) 0 (0) Alanine aminotransferase 2 (7.69) 1 (3.85) 1 (3.85) 0 (0) Aspartate aminotransferase 1 (3.85) 0 (0) 1 (3.85) 0 (0) LDL, low-density lipoprotein; TSH, thyroid-stimulating hormone.
