Introduction
Methods
Study design
Assessments
Statistical analysis
Results
Patients
With on-study SRE
N = 1925 | Without on-study SRE
N = 3618 | |
---|---|---|
Baseline characteristic | ||
Female, n (%) | 863 (44.8) | 1733 (47.9) |
Ethnic group, n (%) | ||
White or Caucasian | 1658 (86.1) | 3014 (83.3) |
Black or African American | 61 (3.2) | 102 (2.8) |
Hispanic/Latino | 92 (4.8) | 202 (5.6) |
Japanese/Asian | 87 (4.5) | 241 (6.7) |
Othera
| 27 (1.4) | 59 (1.6) |
Age (years), mean (SD) | 62.4 (11.9) | 62.3 (12.3) |
Tumor type, n (%) | ||
Breast cancer | 687 (35.7) | 1359 (37.6) |
Prostate cancer | 727 (37.8) | 1174 (32.4) |
Other solid tumors | 511 (26.5) | 1085 (30.0) |
Previous SREs, n (%) | 867 (45.0) | 1284 (35.5) |
uNTX/creatinine (nmol/mmol), mean (SD)b
| 87.6 (191.7) | 84.4 (175.3) |
BPI-SF pain severity score, mean (SD)c
| 4.7 (2.9) | 4.1 (2.9) |
No/mild pain, n (%) | 828 (43.0) | 1855 (51.3) |
Moderate/severe pain, n (%) | 1000 (51.9) | 1514 (41.8) |
BPI-SF pain interference score, mean (SD)d
| ||
Overall | 3.6 (2.6) | 3.1 (2.7) |
Emotional well-being | 3.2 (2.7) | 2.8 (2.7) |
Physical activity | 4.1 (3.0) | 3.4 (3.0) |
AQA score, mean (SD) | 1.5 (1.8) | 1.2 (1.7) |
FACT-G score, mean (SD)e
| 71.9 (16.1) | 72.6 (16.5) |
On-study characteristic | ||
First SREs, n (%) | ||
Pathological fracture | 923 (47.9) | − |
Radiation to bone | 829 (43.1) | − |
Spinal cord compression | 119 (6.2) | − |
Surgery to bone | 54 (2.8) | − |
Breast cancer | Prostate cancer | Other solid tumors | ||||
---|---|---|---|---|---|---|
With on-study SRE N = 687 | Without on-study SRE
N = 1359 | With on-study SRE
N = 727 | Without on-study SRE
N = 1174 | With on-study SRE
N = 511 | Without on-study SRE
N = 1085 | |
Baseline characteristic | ||||||
Female, n (%) | 683 (99.4) | 1346 (99.0) | 0 (0.0) | 0 (0.0) | 180 (35.2) | 387 (35.7) |
Male, n (%) | 4 (0.6) | 13 (1.0) | 727 (100.0) | 1174 (100.0) | 331 (64.8) | 698 (64.3) |
Age, (years), mean (SD) | 56.6 (11.6) | 56.7 (11.5) | 69.7 (8.7) | 71.5 (8.4) | 59.9 (11.0) | 59.6 (11.2) |
BPI-SF pain severity score, mean (SD) | 4.8 (2.7) | 3.9 (2.9) | 4.2 (3.0) | 3.7 (3.0) | 5.4 (2.8) | 4.9 (2.8) |
No/mild pain, n (%) | 292 (42.5) | 750 (55.2) | 369 (50.8) | 676 (57.6) | 167 (32.7) | 429 (39.5) |
Moderate/severe pain, n (%) | 364 (53.0) | 520 (38.3) | 314 (43.2) | 418 (35.6) | 322 (63.0) | 576 (53.1) |
AQA score, mean (SD) | 1.3 (1.7) | 0.9 (1.4) | 1.2 (1.5) | 1.0 (1.4) | 2.2 (2.1) | 1.9 (2.0) |
On-study characteristic | ||||||
First SRE, n (%) | ||||||
Pathological fracture | 450 (65.5) | – | 280 (38.5) | – | 193 (37.8) | – |
Radiation to bone | 201 (29.3) | – | 380 (52.3) | – | 248 (48.5) | – |
Surgery to bone | 20 (2.9) | – | 5 (0.7) | – | 29 (5.7) | – |
Spinal cord compression | 16 (2.3) | – | 62 (8.5) | – | 41 (8.0) | – |
Burden of SREs: worst pain and analgesic use
Overalla
| Breast cancer | Prostate cancer | |||||
---|---|---|---|---|---|---|---|
HR (95 % CI) |
P value | HR (95 % CI) |
P value | HR (95 % CI) |
P value | ||
Moderate/severe pain (patients with no/mild pain at baseline) | N1 = 2683 | N1 = 1042 | N1 = 1045 | ||||
PF | 1.29 (1.07–1.57)
n = 418 | 0.0087 | 1.05 (0.77–1.42)
n = 197 | 0.7649 | 1.53 (1.13–2.08)
n = 149 | 0.0058 | |
RB | 2.51 (2.03–3.10)
n = 349 | <0.0001 | 1.45 (0.89–2.36)
n = 84 | 0.1374 | 2.96 (2.19–3.99)
n = 187 | <0.0001 | |
SCC | 3.07 (1.83–5.13)
n = 48 | <0.0001 | 14.65 (2.32–92.47)
n = 6 | 0.0043 | 2.34 (1.19–4.60)
n = 32 | 0.0132 | |
SB | 2.75 (1.19–6.33)
n = 13 | 0.0177 | 1.95 (0.26, 14.54)
n = 5 | 0.5145 | 3.04 (0.42–22.25)
n = 1 | 0.2731 | |
Strong opioid use (patients with no/low analgesic use at baseline) | N2 = 4340 | N2 = 1711 | N2 = 1631 | ||||
PF | 1.72 (1.46–2.02)
n = 728 | <0.0001 | 1.55 (1.20–1.99)
n = 362 | 0.0008 | 1.73 (1.33–2.25)
n = 238 | <0.0001 | |
RB | 3.31 (2.85–3.86)
n = 609 | <0.0001 | 2.21 (1.56–3.14)
n = 152 | <0.0001 | 3.98 (3.24–4.90)
n = 316 | <0.0001 | |
SCC | 4.81 (3.37–6.87)
n = 80 | <0.0001 | 12.29 (4.91–30.75)
n = 12 | <0.0001 | 4.46 (2.76–7.19)
n = 50 | <0.0001 | |
SB | 2.84 (1.51–5.35)
n = 33 | 0.0012 | 5.40 (2.41–12.14)
n = 15 | <0.0001 | 0.0 (–, –)
n = 3 | 0.9650 |
Burden of SREs: pain interference
Pain interference construct | Median months for patients with on-study SRE | Median months for patients without on-study SRE | Hazard ratio (95 % CI) |
P value |
---|---|---|---|---|
Overall | 9.5 N1 = 1715 | 10.4 N2 = 3196 | 1.19 (1.09–1.29) | <0.0001 |
Emotional well-being | 6.9 N1 = 1687 | 8.4 N2 = 3132 | 1.16 (1.07–1.25) | 0.0004 |
Physical activity | 7.4 N1 = 1560 | 7.8 N2 = 2975 | 1.21 (1.11–1.32) | <0.0001 |
Overall population | Breast cancer | Prostate cancer | |||||
---|---|---|---|---|---|---|---|
Hazard ratio (95 % CI) |
P value | Hazard ratio (95 % CI) |
P value | Hazard ratio (95 % CI) |
P value | ||
Overall interference (includes sleep) | N1 = 4911 | N1 = 1829 | N1 = 1699 | ||||
PF | 1.30 (1.13–1.51)
n = 822 | 0.0004 | 1.31 (1.05–1.63)
n = 403 | 0.0159 | 1.35 (1.05–1.73)
n = 246 | 0.0175 | |
RB | 2.29 (1.98–2.66)
n = 748 | <0.0001 | 2.41 (1.80–3.23)
n = 183 | <0.0001 | 2.09 (1.66–2.64)
n = 349 | <0.0001 | |
SCC | 2.60 (1.84–3.68)
n = 101 | <0.0001 | 4.26 (1.38–13.19)
n = 15 | 0.0120 | 2.36 (1.45–3.86)
n = 50 | 0.0006 | |
SB | 1.70 (0.97–2.98)
n = 44 | 0.0644 | 1.85 (0.68–5.05)
n = 17 | 0.2322 | 2.35 (0.32–17.04)
n = 3 | 0.3977 | |
Emotional well-being | N2 = 4819 | N2 = 1806 | N2 = 1659 | ||||
PF | 1.27 (1.10–1.46)
n = 802 | 0.0012 | 1.20 (0.97–1.48)
n = 399 | 0.1003 | 1.28 (1.00–1.64)
n = 239 | 0.0544 | |
RB | 2.44 (2.12–2.80)
n = 740 | <0.0001 | 2.25 (1.72–2.95)
n = 183 | <0.0001 | 2.18 (1.75–2.71)
n = 337 | <0.0001 | |
SCC | 2.02 (1.41–2.91)
n = 101 | 0.0001 | 4.74 (2.15–10.44)
n = 14 | 0.0001 | 1.64 (0.93–2.89)
n = 52 | 0.0856 | |
SB | 1.28 (0.73–2.23)
n = 44 | 0.3895 | 1.11 (0.41–3.00)
n = 18 | 0.8432 | 1.54 (0.21–11.19)
n = 3 | 0.6718 | |
Physical activity | N3 = 4535 | N3 = 1690 | N3 = 1613 | ||||
PF | 1.40 (1.21–1.62)
n = 741 | <0.0001 | 1.35 (1.09–1.69)
n = 357 | 0.0070 | 1.44 (1.12–1.84)
n = 238 | 0.0039 | |
RB | 2.29 (1.96–2.67)
n = 686 | <0.0001 | 2.30 (1.70–3.10)
n = 168 | <0.0001 | 2.09 (1.64–2.67)
n = 322 | <0.0001 | |
SCC | 2.42 (1.69–3.46)
n = 95 | <0.0001 | 2.26 (0.45–11.37)
n = 12 | 0.3232 | 1.83 (1.08–3.08)
n = 51 | 0.0239 | |
SB | 2.14 (1.20–3.81)
n = 38 | 0.0095 | 2.86 (1.09–7.47)
n = 15 | 0.0326 | 2.09 (0.29–15.12)
n = 3 | 0.4649 |