Table 2.
Disease and health-related quality of life characteristics at baseline, start of second-line therapy, and change from baseline
| Treatment sequence |
|||||||
|---|---|---|---|---|---|---|---|
| ABI-DOCE (n = 178) | ABI-ENZA (n = 99) | ABI-RAD (n = 27) | DOCE-ABI (n = 191) | DOCE-CABA (n = 74) | DOCE-ENZA (n = 116) | ENZA-DOCE (n = 42) | |
| ECOG performance status, n (%) | |||||||
| At baseline | |||||||
| N | 170 | 93 | 27 | 182 | 67 | 98 | 34 |
| 0 | 88 (51.8) | 49 (52.7) | 16 (59.3) | 68 (37.4) | 30 (44.8) | 50 (51.0) | 21 (61.8) |
| 1 | 71 (41.8) | 35 (37.6) | 10 (37.0) | 103 (56.6) | 28 (41.8) | 43 (43.9) | 13 (38.2) |
| ≥2 | 11 (6.5) | 9 (9.7) | 1 (3.7) | 11 (6.0) | 9 (13.4) | 5 (5.1) | 0 |
| At start of second-line therapy | |||||||
| N | 151 | 87 | 23 | 169 | 64 | 87 | 24 |
| 0 | 38 (25.2) | 30 (34.5) | 6 (26.1) | 36 (21.3) | 13 (20.3) | 23 (26.4) | 6 (25.0) |
| 1 | 88 (58.3) | 39 (44.8) | 11 (47.8) | 113 (66.9) | 29 (45.3) | 39 (44.8) | 13 (54.2) |
| ≥2 | 25 (16.6) | 18 (20.6) | 6 (26.1) | 20 (11.8) | 22 (34.4) | 25 (28.7) | 5 (20.8) |
| Change from baseline | |||||||
| N | 146 | 83 | 23 | 167 | 61 | 83 | 22 |
| Improved | 12 (8.2) | 5 (6.0) | 1 (4.3) | 14 (8.4) | 1 (1.6) | 4 (4.8) | 1 (4.5) |
| No change | 66 (45.2) | 48 (57.8) | 9 (39.1) | 110 (65.9) | 23 (37.7) | 38 (45.8) | 8 (36.4) |
| Worsened | 68 (46.6) | 30 (36.1) | 13 (56.5) | 43 (25.7) | 37 (60.7) | 41 (49.4) | 13 (59.1) |
| Prostate-specific antigen (ng/ml) | |||||||
| At baseline | |||||||
| N | 173 | 96 | 27 | 189 | 70 | 115 | 41 |
| Median (range) | 41.3 (1.5–5000.0) | 33.8 (0.1–829.0) | 21.9 (1.9–173.0) | 42.4 (0.9–2108.0) | 46.2 (1.0–2559.6) | 34.9 (0.4–1900.0) | 32.0 (2.5–1452.6) |
| At start of second-line therapy | |||||||
| N | 157 | 87 | 24 | 175 | 67 | 110 | 39 |
| Median (range) | 86.7 (0.2–5000.0) | 52.5 (0.5–7000.0) | 108.2 (6.2–853.0) | 68.9 (0.1–2197.0) | 81.0 (0.0–2887.5) | 46.5 (0.4–3088.0) | 59.5 (0.2–545.0) |
| Change from baseline | |||||||
| N | 149 | 82 | 24 | 165 | 61 | 109 | 39 |
| Median (range) | 33.2 (−149.1 to 1715.1) | 15.1 (−653.4 to 6846.8) | 49.8 (−77.0 to 595.0) | 8.5 (−1874.9 to 1612.5) | 1.1 (−842.8 to 971.0) | 7.7 (−1864.6 to 2018.0) | 10.0 (−907.6 to 332.0) |
| Lactate dehydrogenase (U/l) | |||||||
| At baseline | |||||||
| N | 76 | 44 | 11 | 87 | 34 | 35 | 7 |
| Median (range) | 316.5 (134–1200) | 209.0 (3–680) | 301.0 (164–1207) | 288.0 (5–1096) | 328.0 (4–3232) | 302.0 (177–815) | 236.0 (183–371) |
| At start of second-line therapy | |||||||
| N | 78 | 44 | 10 | 62 | 35 | 40 | 10 |
| Median (range) | 323.5 (4–1947) | 258.0 (156–1323) | 342.0 (160–994) | 287.5 (5–1346) | 413.0 (3–6251) | 287.0 (158–3460) | 268.0 (179.0–452.0) |
| Change from baseline | |||||||
| N | 49 | 26 | 10 | 37 | 25 | 21 | 5 |
| Median (range) | 47.0 (−191 to 1332) | 22.0 (−417 to 134) | 16.0 (−461.0 to 551) | 24.0 (−397 to 355) | 134.0 (−2787 to 5557) | 37.0 (−300 to 356) | −22.0 (−90.0 to 36.0) |
| Haemoglobin (g/dl) | |||||||
| At baseline | |||||||
| N | 155 | 83 | 24 | 175 | 67 | 106 | 38 |
| Median (range) | 13.0 (7.5–15.9) | 13.2 (9.1–16.9) | 13.4 (9.1–15.9) | 13.0 (7.4–16.1) | 12.9 (7.3–16.3) | 13.1 (7.4–15.5) | 13.1 (9.8–15.8) |
| At start of second-line therapy | |||||||
| N | 152 | 74 | 24 | 165 | 63 | 105 | 38 |
| Median (range) | 12.0 (6.3–15.6) | 12.2 (7.7–17.6) | 12.4 (9.9–15.0) | 12.0 (7.9–16.3) | 11.8 (7.8–15.0) | 12.0 (6.8–15.5) | 12.2 (7.7–15.3) |
| Change from baseline | |||||||
| N | 137 | 64 | 23 | 148 | 60 | 96 | 35 |
| Median (range) | −0.8 (−5.1 to 5.0) | −0.5 (−4.5 to 3.7) | −0.7 (−2.9 to 1.5) | −0.7 (−4.4 to 5.5) | −0.7 (−4.7 to 3.6) | −0.6 (−5.4 to 3.5) | −0.6 (−3.6 to 2.5) |
| Alkaline phosphatase (U/l) | |||||||
| At baseline | |||||||
| N | 136 | 73 | 25 | 128 | 56 | 90 | 35 |
| Median (range) | 117.5 (1–1520) | 93.0 (2–2337) | 122.0 (42–1687) | 104.5 (3–1850) | 129.0 (1–3092) | 119.5 (6–1429) | 88.0 (22–5785) |
| At start of second-line therapy | |||||||
| N | 133 | 64 | 21 | 115 | 48 | 96 | 35 |
| Median (range) | 173.0 (44–2016) | 104.0 (32–1659) | 178.0 (37–1587) | 135.0 (2–3728) | 155.0 (1–1985) | 130.5 (11–3510) | 101.0 (17–3756) |
| Change from baseline | |||||||
| N | 113 | 52 | 21 | 84 | 39 | 81 | 34 |
| Median (range) | 27.0 (−414 to 1465) | 10.7 (−159 to 1546) | 30.0 (−941 to 1000) | 3.0 (−1130 to 1878) | 0.6 (−621 to 1774) | 2.0 (−1548 to 3440) | 0.0 (−2029 to 1253) |
| EQ-5D-5L, pain/discomfort dimension, n (%) | |||||||
| At baseline | |||||||
| N | 126 | 72 | 22 | 144 | 58 | 80 | 35 |
| 1: No pain | 46 (36.5) | 32 (44.4) | 5 (22.7) | 35 (24.3) | 14 (24.1) | 21 (26.3) | 9 (25.7) |
| 2: Slight pain | 48 (38.1) | 24 (33.3) | 12 (54.5) | 50 (34.7) | 23 (39.7) | 33 (41.3) | 17 (48.6) |
| 3: Moderate pain | 24 (19.0) | 12 (16.7) | 4 (18.2) | 44 (30.6) | 15 (25.9) | 21 (26.3) | 9 (25.7) |
| 4: Severe pain | 8 (6.3) | 4 (5.6) | 1 (4.5) | 15 (10.4) | 6 (10.3) | 3 (3.8) | 0 |
| 5: Extreme pain | 0 | 0 | 0 | 0 | 0 | 2 (2.5) | 0 |
| At start of second-line therapy | |||||||
| N | 80 | 43 | 11 | 69 | 38 | 60 | 15 |
| 1: No pain or discomfort | 22 (27.5) | 12 (27.9) | 0 | 13 (18.8) | 5 (13.2) | 15 (25.0) | 3 (20.0) |
| 2: Slight pain or discomfort | 22 (27.5) | 12 (27.9) | 6 (54.5) | 28 (40.6) | 14 (36.8) | 22 (36.7) | 3 (20.0) |
| 3: Moderate pain or discomfort | 27 (33.8) | 13 (30.2) | 5 (45.5) | 21 (30.4) | 13 (34.2) | 21 (35.0) | 7 (46.7) |
| 4: Severe pain or discomfort | 9 (11.3) | 5 (11.6) | 0 | 6 (8.7) | 4 (10.5) | 2 (3.3) | 1 (6.7) |
| 5: Extreme pain or discomfort | 0 | 1 (2.3) | 0 | 1 (1.4) | 2 (5.3) | 0 | 1 (6.7) |
| Change from baseline | |||||||
| N | 69 | 36 | 8 | 57 | 33 | 38 | 9 |
| Improved | 16 (23.2) | 2 (5.6) | 0 | 17 (29.8) | 6 (18.2) | 11 (28.9) | 2 (22.2) |
| No change | 27 (39.1) | 20 (55.6) | 4 (50.0) | 25 (43.9) | 13 (39.4) | 19 (50.0) | 3 (33.3) |
| Worsened | 26 (37.7) | 14 (38.9) | 4 (50.0) | 15 (26.3) | 14 (42.4) | 8 (21.1) | 4 (44.4) |
| EQ-5D-5L, VAS | |||||||
| At baseline | |||||||
| N | 124 | 70 | 19 | 144 | 56 | 80 | 34 |
| Median (range) | 75.0 (20–100) | 70.0 (25–95) | 75.0 (30–100) | 67.5 (0–100) | 70.0 (30–100) | 75.0 (10–98) | 75.0 (40–100) |
| At start of second-line therapy | |||||||
| N | 78 | 43 | 10 | 67 | 38 | 60 | 15 |
| Median (range) | 70.0 (0–99) | 60.0 (18–90) | 72.5 (50–90) | 65.0 (10–95) | 60.0 (20–95) | 70.0 (15–99) | 55.0 (20–90) |
| Change from baseline | |||||||
| N | 68 | 38 | 7 | 56 | 33 | 39 | 10 |
| Median (range) | 0.0 (−65 to 40) | −10.0 (−52 to 15) | −5.0 (−10 to 10) | 0.0 (−50 to 38) | −5.0 (−50 to 30) | −10.0 (−60 to 30) | −15.0 (−70 to 15) |
ABI = abiraterone acetate plus prednisone/prednisolone; CABA = cabazitaxel; DOCE = docetaxel; ECOG = Eastern Cooperative Oncology Group; ENZA = enzalutamide; EQ-5D-5L = EuroQol 5-dimension 5-level questionnaire; RAD = radium-223; VAS = visual analogue scale.