Table 2. HRQoL best response for the overall population and by BRCA status.
Overall population,
n
(%) |
BRCAm,
n
(%) |
gBRCAm,
n
(%) |
||||
---|---|---|---|---|---|---|
Olaparib | Placebo | Olaparib | Placebo | Olaparib | Placebo | |
TOI | n=115 | n=111 | n=64 | n=53 | n=45 | n=37 |
Baseline score, mean (s.d.) | 81.7 (11.8) | 81.5 (11.6) | 79.9 (12.1) | 79.5 (12.1) | 79.5 (12.3) | 81.0 (11.0) |
Improved | 23 (20.0) | 20 (18.0) | 16 (25.0) | 10 (18.9) | 12 (26.7) | 3 (8.1) |
No change | 72 (62.6) | 67 (60.4) | 38 (59.4) | 30 (56.6) | 27 (60.0) | 22 (59.5) |
Worsened | 16 (13.9) | 20 (18.0) | 7 (10.9) | 10 (18.9) | 4 (8.9) | 9 (24.3) |
Non-evaluable | 4 (3.5) | 4 (3.6) | 3 (4.7) | 3 (5.7) | 2 (4.4) | 3 (8.1) |
FOSI | n=117 | n=115 | n=66 | n=56 | n=46 | n=39 |
Baseline score, mean (s.d.) | 26.1 (3.4) | 25.4 (3.8) | 25.9 (3.4) | 24.8 (4.1) | 25.8 (3.3) | 25.1 (4.1) |
Improved | 20 (17.1) | 17 (14.8) | 14 (21.2) | 9 (16.1) | 12 (26.1) | 5 (12.8) |
No change | 74 (63.2) | 74 (64.3) | 39 (59.1) | 36 (64.3) | 26 (56.5) | 23 (59.0) |
Worsened | 20 (17.1) | 21 (18.3) | 11 (16.7) | 9 (16.1) | 6 (13.0) | 9 (23.1) |
Non-evaluable | 3 (2.6) | 3 (2.6) | 2 (3.0) | 2 (3.6) | 2 (4.3) | 2 (5.1) |
FACT-O | n=114 | n=111 | n=63 | n=53 | n=45 | n=37 |
Baseline score, mean (s.d.) | 121.9 (17.3) | 119.7 (17.4) | 118.9 (18.1) | 115.9 (18.9) | 119.5 (18.5) | 118.6 (17.2) |
Improved | 24 (21.1) | 21 (18.9) | 17 (27.0) | 11 (20.8) | 13 (28.9) | 4 (10.8) |
No change | 68 (59.6) | 63 (56.8) | 35 (55.6) | 26 (49.1) | 25 (55.6) | 19 (51.4) |
Worsened | 20 (17.5) | 24 (21.6) | 10 (15.9) | 14 (26.4) | 6 (13.3) | 12 (32.4) |
Non-evaluable | 2 (1.8) | 3 (2.7) | 1 (1.6) | 2 (3.8) | 1 (2.2) | 2 (5.4) |
Nausea | n=115 | n=113 | n=64 | n=54 | n=44 | n=37 |
Improved | 5 (4.3) | 11 (9.7) | 0 (0) | 6 (11.1) | 0 (0) | 4 (10.8) |
No change | 69 (60.0) | 77 (68.1) | 43 (67.2) | 38 (70.4) | 31 (70.5) | 24 (64.9) |
Worsened | 37 (32.2) | 19 (16.8) | 18 (28.1) | 5 (9.3) | 12 (27.3) | 4 (10.8) |
Non-evaluable | 4 (3.5) | 6 (5.3) | 3 (4.7) | 5 (9.3) | 1 (2.3) | 5 (13.5) |
Vomiting | n=115 | n=111 | n=65 | n=54 | n=46 | n=38 |
Improved | 6 (5.2) | 5 (4.5) | 2 (3.1) | 2 (3.7) | 2 (4.3) | 1 (2.6) |
No change | 95 (82.6) | 94 (84.7) | 54 (83.1) | 45 (83.3) | 38 (82.6) | 31 (81.6) |
Worsened | 7 (6.1) | 6 (5.4) | 3 (4.6) | 3 (5.6) | 3 (6.5) | 2 (5.3) |
Non-evaluable | 7 (6.1) | 6 (5.4) | 6 (9.2) | 4 (7.4) | 3 (6.5) | 4 (10.5) |