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Table 2 Five-year iDFS events in patients treated with neratinib and placebo relative to PIK3CA status

From: PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial

Population

Neratinib

Placebo

  

n

iDFS events, n

n

iDFS events, n

HR (95% CI)

Two-sided P valuea

ITT

1420

116

1420

163

0.73 (0.57–0.92)b

0.008b

Correlative cohort

593

45

608

70

0.67 (0.45–0.96)

0.032

PIK3CA mutation positive

104

7

106

17

0.43 (0.17–1.01)

0.056

PIK3CA mutation negative

385

27

396

42

0.66 (0.40–1.06)

0.089

PIK3CA amplified

33

1

28

4

0.20 (0.01–1.33)

0.106

PIK3CA non-amplified

316

29

325

36

0.85 (0.52–1.39)

0.521

PIK3CA alteredc

130

8

132

20

0.41 (0.17–0.90)

0.028

  1. A total of nine patients (seven patients in the neratinib arm and two patients in the placebo arm) had tumors harboring both a mutation and amplification
  2. aLog-rank test
  3. bStratified analysis
  4. cTumors harboring either a PIK3CA mutation or PIK3CA amplification
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Breast Cancer Research

ISSN: 1465-542X

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