Table 1.

Baseline demographics and patient characteristics by PIK3CA mutation status

CharacteristicPIK3CA-mutated (n = 20)PIK3CA-MND (n = 27)PIK3CA mutation status unknown (n = 13)All patients (N = 60)
Median age, years (range)61.0 (41–78)57.0 (31–82)63.0 (44–75)61.5 (31–82)
ECOG PS, n (%)
 09 (45.0)15 (55.6)10 (76.9)34 (56.7)
 111 (55.0)12 (44.4)3 (23.1)26 (43.3)
Median time from primary diagnosis, months (range)n = 17; 65.3 (6.7–183.1)n = 23; 56.7 (11.6–315.3)n = 12; 81.7 (16.0–167.7)n = 52; 64.2 (6.7–315.3)
Bone-only disease, n (%)
 Yes1 (5.0)4 (14.8)2 (15.4)7 (11.7)
 No19 (95.0)23 (85.2)11 (84.6)53 (88.3)
Visceral disease, n (%)
 Yes14 (70.0)17 (63.0)8 (61.5)39 (65.0)
 No6 (30.0)10 (37.0)5 (38.5)21 (35.0)
Endocrine sensitivity, n (%)a
 Yes7 (35.0)9 (33.3)1 (7.7)17 (28.3)
 No13 (65.0)18 (66.7)12 (92.3)43 (71.7)
Median number of prior hormonal therapies, (range)n = 20; 2.0 (1.0–5.0)n = 26; 2.0 (1.0–4.0)n = 13; 2.0 (1.0–5.0)n = 59; 2.0 (1.0–5.0)
Prior treatment, n (%)b
 Aromatase inhibitor18 (90.0)21 (77.8)13 (100.0)52 (86.7)
 Everolimus4 (20.0)3 (11.1)3 (23.1)10 (16.7)
 Letrozole13 (65.0)14 (51.9)8 (61.5)35 (58.3)
 Anastrozole6 (30.0)7 (25.9)6 (46.2)19 (31.7)
 Exemestane10 (50.0)6 (22.2)8 (61.5)24 (40.0)
 Tamoxifen10 (50.0)19 (70.4)7 (53.8)36 (60.0)
Prior chemotherapy, n (%)
 Adjuvant setting8 (40.0)15 (55.6)6 (46.2)29 (48.3)
 Metastatic setting4 (20.0)8 (29.6)4 (30.8)16 (26.7)
Prior hormonal therapy, n (%)
 Adjuvant setting12 (60.0)21 (77.8)9 (69.2)42 (70.0)
 Metastatic setting14 (70.0)12 (44.4)11 (84.6)37 (61.7)
  • Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; MND, mutation-not-detected; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit-alpha.

  • aEndocrine sensitivity was defined based on a positive response to either of the following: (i) In patients with at least one hormonal treatment in the metastatic setting: treatment duration was ≥24 weeks from the most recent hormonal therapy in the metastatic setting, if the best response was missing. Documented complete/partial response or stable disease ≥24 weeks from the most recent hormonal therapy in the metastatic setting, if the best response was available. (ii) In patients without hormonal therapy in the metastatic setting, but who received hormonal treatment in the adjuvant setting: treatment duration of the most recent hormonal treatment in the adjuvant setting was ≥24 months.

  • bPatients received prior treatment in the adjuvant or metastatic setting. For the “median time from primary diagnosis” and “median number of prior hormonal therapies” categories, the number of patients for whom data were available is presented.