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FIGURE 1.

Consort diagram.
Consort diagram.

FIGURE 2.

Kaplan-Meier graph showing association between PIK3CA mutation and overall survival.
Kaplan-Meier graph showing association between PIK3CA mutation and overall survival.

FIGURE 3.

Kaplan-Meier graph showing association between PIK3CA mutation and distant metastasis-free survival
Kaplan-Meier graph showing association between PIK3CA mutation and distant metastasis-free survival

Simple Cox proportional hazards model for DMFS in the PIK3CA mutated patient cohort

Characteristic HR 95% CI Adj p
Age 0.99 0.96–1.02 1.0
Duration of TAM 0.92 0.75–1.14 1.0
Duration of AIs 1.07 0.90–1.28 1.0

Distribution of systemic therapy in all patients and according to PIK3CA mutation status

Systemic therapy All ptsN (%) PIK3CA mutated ptsN (%) PIK3CA non-mutated ptsN (%)
None 12 (3) 5 (3) 7 (3)
ET only 249 (68) 115 (70) 134 (67)
ChT only 13 (4) 5 (3) 8 (4)
ET and ChT 91 (25) 39 (24) 52 (26)
None ET 25 (7) 10 (6) 15 (7)
ET with TAM 106 (29) 45 (27) 61 (30)
ET with AIs 127 (35) 54 (33) 73 (37)
Sequence TAM-AI 107 (29) 55 (34) 52 (26)
Median duration (range) of ET 5 (0.2–16.7) 5 (0.4–16.7) 5 (0.2–11.2)

Advanced Cox proportional hazards model for OS in the PIK3CA mutated patient cohort

Characteristic HR 95% CI Adj p
Age 1.05 1.02–1.08 0.014
Tumor size 1.38 0.90–2.10 0.84
Grade
   G1 Ref
   G2 1.41 0.59–3.38 1.0
   G3 5.52 1.67–18.18 0.04
Ki-67 0.94 0.72–1.22 1.0
PR 1 0.99–1.01 1.0
PIK3CA status
  Other than exon 20 Ref
  Only exon 20 1.32 0.79–2.21 1.0
No. of positive axillary LNs 1.58 1.32–1.88 < 0.001
Duration of TAM 0.68 0.55–0.86 0.01
Duration of AI 0.73 0.60–0.88 0.01

Characteristics of the included patients and their tumors

Characteristic All patients (n = 365; 100%) PIK3CA mutated (n = 164; 45%) PIK3CA non-mutated (n = 201; 55%)
Median age (range) (yrs) 62.8 (33–90) 63.1 62.4
Median tumor size (mm) 21 19 21
Nodal status
   N0 209 (57) 100 (61) 109 (54)
   N1 84 (23) 37 (22) 47 (23)
   N2 26 (7) 1 (7) 15 (8)
   N3 46 (13) 16 (10) 30 (15)
Tumor grade
   G1 52 (14) 20 (12) 32 (16)
   G2 270 (74) 134 (82) 136 (68)
   G3 43 (12) 10 (6) 33 (16)
IHC* subtype
   ER+/PR+/HER2− 299 (82) 136 (46) 159 (54)
   ER+/PR−/HER2− 39 (11) 14 (36) 25 (64)
   HER2 + 20 (6) 9 (45) 11 (55)
   ER−/PR−/HER2− 7 (2) 2 (29) 5 (71)
Median Ki-67 (range) (%) 3 (1–50) 2.5 (1–50) 3 (140)
Mitotic score
   M1 284 (78) 138 (84) 146 (73)
   M2 55 (15) 19 (12) 36 (18)
   M3 26 (7) 7 (4) 19 (9)
Presence of LVI 24 (7) 4 (2) 20 (10)
Median TILs (range) (%) 3 (150) 3 3
Median follow-up time (range) (yrs) 10.8 (0.118.6) 10.8 10.7

Advanced Cox proportional hazards model for DMFS in the PIK3CA mutated patient cohort

Characteristic HR 95% CI Adj p
Age 1.01 0.97–1.05 1.0
Tumor size 0.99 0.57–1.71 1.0
Grade
   G1 Ref
   G2 0.91 0.26–3.22 1.0
   G3 1.03 0.16–6.83 1.0
Ki-67 1.35 0.93–1.95 1.0
PR 1 0.99–1.02 1.0
PIK3CA status
   Other than exon 20 Ref
   Only exon 20 2.19 1.01–4.80 0.582
No. of positive axillary LNs 1.64 1.30–2.06 < 0.001
Duration of TAM 1.02 0.81–1.29 1.0
Duration of AIs 1.06 0.87–1.28 1.0

Simple Cox proportional hazards model for OS in the PIK3CA mutated patient cohort

Characteristic HR 95% CI Adj p
Age 1.05 1.02–1.07 < 0.001
Duration of TAM 0.73 0.61–0.88 0.002
Duration of AIs 0.79 0.67–0.93 0.005
eISSN:
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Language:
English
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Journal Subjects:
Medicine, Clinical Medicine, Internal Medicine, Haematology, Oncology, Radiology