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. Author manuscript; available in PMC: 2022 Apr 1.
Published in final edited form as: Eur Urol. 2020 Oct 1;79(4):442–445. doi: 10.1016/j.eururo.2020.09.024

Table 1 –

Confirmed radiographic responses in the phase 3 PROfound trial

Cohorts A + B Cohort A a Cohort B b
Olaparib arm (n) 138 84 54 *
 With radiographic response, n (%) 30 (22) 28 (33) 2 (4) *
Control arm (n) 67 43 24 *
 With radiographic response, n (%) 3 (4) 1 (2) 2 (8) *
Response to olaparib vs control
 Adjusted OR (95% CI)c 5.93 (2.01–25.4) 20.9 (4.18–379)
 Unadjusted OR (95% CI)c 5.93 (1.72–31.3) * 21.0 (3.15–879)* 0.42 (0.03–6.25) *
 RR (95% CI)c 4.86 (1.54–15.3)* 14.3 (2.02–101) * 0.44 (0.07–2.97) *
 RD in nercentage noints (95% CI) d 17 (9–26) * 31 (20–42) * −5 (−17 to 8) *

CI = confidence interval; OR = odds ratio; RD = risk difference; RR = risk ratio.

*

Not reported by de Bono et al. (2020) [2] but calculable from the data provided.

a

Patients with tumor DNA alterations in the three main homologous recombination repair genes (BRCA2, BRCA1, or ATM).

b

Patients with tumor DNA alterations in 12 additional genes (BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L).

c

OR and RR values >1 favor olaparib. ORs in the main article were adjusted for stratification factors; however, differences between adjusted and unadjusted point estimates are negligible. RRs are also presented here because ORs always exaggerate results when an outcome is common [8]: compare the OR of 21.0 to the RR of 14.3 for cohort A.

d

RD values >0 percentage points favor olaparib.