Table 3.

Analysis of BRCA1/BRCA2 mutational frequency and HRD in the olaparib arm, including total BRCA1/2 mutations and stratification by somatic mutations—Study 19

Number of patients with each mutation shownLT respondersN = 32ST respondersN = 21P value (Fisher exact test)
BRCA status availableN = 32N = 19
BRCA mutation22a (69%)10 (53%)0.2179b
  BRCA1 mutation10 (45%)7 (70%)1.0000b
  BRCA2 mutation13 (59%)3 (30%)0.0631b
BRCA WT10 (31%)9 (47%)
 Unknown/missing (excluded from analysis)2 missing
Somatic BRCA mutations availableN = 32N = 19
 Olaparib treated (n = 53)63
BRCA mutation6a (20%)3 (16%)1.0000
  BRCA1 mutation211.0000
  BRCA2 mutation520.6909
 Placebo treated (n = 45)13
BRCA1 methylation status availableN = 23N = 14
 Methylated02 (14%)
 Unmethylated23 (100%)12 (86%)
 Unknown/missing (excluded from analysis)9 missing7 missing
HRD score availableN = 24N = 13
 HRD score (≥42)21 (88%)9 (69%)0.2128
 HRD score (<42)3 (12%)4 (31%)
HRD status availableN = 26N = 17
 HR deficient25 (96%)13 (76%)0.0707
 HR nondeficient1 (4%)4 (24%)
  • NOTE: HRD scores are given for LT responders and ST responders, and HRD status is defined as a high HRD score and/or presence of a BRCA1/2 mutation.

  • aOne LT responder had both BRCA1 and BRCA2 mutations.

  • bP value between groups compared with WT.