TABLE A2.
rPFS and OS by Each Single HRR Gene Mutation (without comutation with the other five genes)
| Gene Mutation | End Point | Arm | No. | No. of Events | Median Survival, Months | HRa (95% CI) | HRb (95% CI) |
|---|---|---|---|---|---|---|---|
| ATMm | rPFS BICR | PARP + ARPI | 111 | 52 | 19 (17-NE) | 0.96 (0.65 to 1.42) | 0.93 (0.62 to 1.39) |
| Placebo + ARPI | 112 | 49 | 19 (14-NE) | ||||
| OS | PARP + ARPI | 111 | 46 | 37 (29-NE) | 0.95 (0.63 to 1.43) | 0.89 (0.59 to 1.36) | |
| Placebo + ARPI | 112 | 48 | 33 (28-NE) | ||||
| BRCA1m | rPFS BICR | PARP + ARPI | 28 | 9 | NE (16-NE) | 0.44 (0.17 to 1.12) | 0.23 (0.06 to 0.91) |
| Placebo + ARPI | 18 | 10 | 12 (4-NE) | ||||
| OS | PARP + ARPI | 28 | 10 | NE (24-NE) | 0.63 (0.24 to 1.68) | 0.46 (0.12 to 1.69) | |
| Placebo + ARPI | 18 | 8 | 26 (15-NE) | ||||
| BRCA2m | rPFS BICR | PARP + ARPI | 178 | 54 | NE (22-NE) | 0.29 (0.21 to 0.4) | 0.26 (0.18 to 0.36) |
| Placebo + ARPI | 183 | 121 | 10 (8-11) | ||||
| OS | PARP + ARPI | 178 | 69 | 33 (28-NE) | 0.66 (0.48 to 0.9) | 0.63 (0.46 to 0.88) | |
| Placebo + ARPI | 183 | 96 | 24 (21-28) | ||||
| CDK12m | rPFS BICR | PARP + ARPI | 55 | 24 | 22 (16-NE) | 0.53 (0.31 to 0.89) | 0.54 (0.31 to 0.93) |
| Placebo + ARPI | 61 | 33 | 16 (11-19) | ||||
| OS | PARP + ARPI | 55 | 20 | NE (29-NE) | 0.47 (0.27 to 0.83) | 0.49 (0.28 to 0.88) | |
| Placebo + ARPI | 61 | 36 | 29 (20-34) | ||||
| CHEK2m | rPFS BICR | PARP + ARPI | 58 | 21 | NE (14-NE) | 0.84 (0.47 to 1.5) | 0.8 (0.44 to 1.44) |
| Placebo + ARPI | 64 | 31 | 18 (11-NE) | ||||
| OS | PARP + ARPI | 58 | 21 | NE (25-NE) | 0.97 (0.54 to 1.74) | 0.96 (0.53 to 1.75) | |
| Placebo + ARPI | 64 | 26 | 34 (24-NE) | ||||
| PALB2m | rPFS BICR | PARP + ARPI | 19 | 10 | 29 (8-NE) | 0.41 (0.16 to 1.04) | 0.27 (0.07 to 0.98) |
| Placebo + ARPI | 13 | 10 | 11 (2-14) | ||||
| OS | PARP + ARPI | 19 | 9 | 29 (15-NE) | 0.63 (0.24 to 1.65) | 0.49 (0.14 to 1.73) | |
| Placebo + ARPI | 13 | 9 | 20 (11-38) |
Abbreviations: ARPI, androgen receptor pathway inhibitor; BICR, blinded independent central review; HR, hazard ratio; HRR, homologous recombination repair; NE, not estimable; OS, overall survival; PARP, poly(ADP-ribose) polymerase; rPFS, radiographic progression-free survival.
HR estimated from a Cox proportional hazards model stratified by trial (HR <1 favors the treatment group).
HR estimated from a Cox proportional hazards model stratified by trial and adjusted by baseline Eastern Cooperative Oncology Group performance status, metastasis site (bone only v visceral disease v others) and Gleason score (≤7 v >7; HR < 1 favors the PARPi group).