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Table 2 Aggregated trial characteristicsa,b

From: PIK3CA mutation status, progression and survival in advanced HR + /HER2- breast cancer: a meta-analysis of published clinical trials

  

Study cohorts, stratified by PIK3CA mutation status

Full Sample

Mutated

Wild

N = 33

N = 17

N = 16

Study and Patient characteristics

 Total number of patients

3,219

1,386

1,833

PIK3CA Mutation Testing Methodology, N (%)

 ctDNA testing

18 (54.5%)

9 (52.9%)

9 (56.3%)

 Tissue testing

13 (39.4%)

7 (41.2%)

6 (37.5%)

 Missing

2 (6.1%)

1 (5.9%)

1 (6.3%)

Percentage of Patients with Prior Chemotherapy, median (range)

 Overallc

67.0 (27.4, 95.4)

64.6 (27.4, 92.0)

72.0 (29.8, 95.4)

 For metastatic diseasec

27.8 (0.0, 35.0)

27.4 (0.0, 34.0)

29.9 (0.0, 35.0)

Median Follow-up Time (Months)

 Overall

14.6 (7.4, 45.1)

14.6 (8.9, 45.1)

14.5 (7.4, 45.1)

Study treatment

 Any Fulvestrant

23 (69.7%)

12 (70.6%)

11 (68.8%)

 Abemaciclib + Fulvestrant

2 (6.1%)

1 (5.9%)

1 (6.3%)

 Placebo + Fulvestrant

19 (57.6%)

10 (58.8%)

9 (56.3%)

 Palbociclib + Fulvestrant

2 (6.1%)

1 (5.9%)

1 (6.3%)

 Everolimus + Exemestane

4 (12.1%)

2 (11.8%)

2 (12.5%)

 Placebo + Exemestane

4 (12.1%)

2 (11.8%)

2 (12.5%)

 Other

2 (6.1%)

1 (5.9%)

1 (6.3%)

Survival outcomes

 Median progression-free survival (months)

5.6 (1.4, 23.4)

5.4 (1.4, 19.0)

6.2 (1.7, 23.4)

 6 Month Survival Rate (%)e

46.2 (10.8, 93.4)

43.0 (10.8, 91.0)

53.5 (19.8, 93.4)

 12 Month Survival Rate (%)e

31.7 (5.8, 76.4)

29.2 (18.8, 66.7)

32.6 (5.8, 76.4)

 18 Month Survival Rate (%)e

22.7 (3.2, 64.8)

20.0 (18.4, 51.3)

26.4 (3.2, 64.8)

 Median overall survival (months)d

32.2 (19.6, 55.5)

26.9 (19.6, 44.5)

37.8 (23.5, 55.5)

  1. Abbreviations: ctDNA, circulating tumor deoxyribose nucleic acid, PIK3CA Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha
  2. Notes: aMedians and ranges are shown for continuous characteristics, counts and percentages are shown for categorical characteristics. Percentages may not total 100 because of rounding
  3. bUnit of observation is study cohort, which refers to subpopulation of study arms based on PIK3CA mutation status
  4. cMedians and ranges calculated from available data. Overall percentages of patients with prior chemotherapy were available for 11 study cohorts (mutated (MT): 6, wild (WT): 5), percentages for metastatic disease were available for 9 study cohorts (MT: 5, WT: 4)
  5. dMedians and ranges calculated from available data. Median OS were available for 14 study cohorts (MT: 8, WT: 6)
  6. eMedians and ranges calculated from available data. PFS rates at 6 months were available for 31 study cohorts (MT: 16, WT: 15), at 12 months for 22 study cohorts (MT: 10, WT: 12), at 18 months for 14 study cohorts (MT: 7, WT: 7)