Table 3.
Breakthrough Cancer Pain Characteristics and Use of FPNS During Radiotherapy
| Initial Assessmenta | W1 | W2 | W3 | W4 | W5 | W6 | End of Radiotherapy | |
|---|---|---|---|---|---|---|---|---|
| Investigator Assessments of BTcP (N=83) | N=83 | N=74 | N=55 | N=38 | N=22 | N=10 | N=1 | N=79 |
| Type of pain, n (%) | N=83 | N=74 | N=54 | N=38 | N=22 | N=10 | N=1 | N=78 |
| No pain | 1 (1.4) | 1 (1.9) | 1 (2.6) | 0 | 0 | 0 | 7 (9.0) | |
| Nociceptive | 36 (43.4) | 29 (39.2) | 18 (33.3) | 9 (23.7) | 2 (9.1) | 1 (10.0) | 0 | 25 (32.1) |
| Neuropathic | 0 | 0 | 0 | 1 (2.6) | 1 (4.5) | 0 | 0 | 1 (1.3) |
| Mixed | 47 (56.6) | 44 (59.5) | 35 (64.8) | 27 (71.1) | 19 (86.4) | 9 (90.0) | 1 (100.0) | 45 (57.7) |
| Causes of BTcP, n (%)b | N=83 | N=73 | N=53 | N=37 | N=22 | N=10 | N=1 | N=71 |
| Procedural pain | 6 (7.2) | 3 (4.1) | 1 (1.9) | 2 (5.4) | 2 (9.1) | 0 | 0 | 2 (2.8) |
| Predictable pain | 75 (90.4) | 63 (86.3) | 49 (92.5) | 33 (89.2 | 19 (86.4) | 10 (100.0) | 1 (100.0) | 64 (90.1) |
| Spontaneous pain | 23 (27.7) | 23 (31.5) | 10 (18.9) | 8 (21.6) | 6 (27.3) | 1 (10.0) | 0 | 19 (26.8) |
| Patient assessments of BTcP (at least one completed, N=58) |
N=50 | N=52 | N=41 | N=29 | N=15 | N=9 | N=3 | N=15 |
| Intensity of BTcP episodesd | N=48 | N=52 | N=40 | N=29 | N=15 | N=8 | N=3 | N=15 |
| Mean (SD) | 5.1 (2.3) | 4.9 (2.1) | 5.1 (1.8) | 5.2 (1.9) | 5.0 (1.7) | 3.4 (2.2) | 4.1 (3.4) | 4.4 (2.0) |
| Median (range) | 5.0 (0.0–10.0) |
5.1 (1.0–9.1) |
5.0 (0.0–8.1) |
5.4 (1.0–8.3) |
5.0 (1.6–8.5) |
3.6 (0.6–6.5) |
5.3 (0.3–6.8) |
4.0 (0.0–8.0) |
| BTcP intensity by classd, n (%) | ||||||||
| ≤4 | 19 39.6%) | 17 (32.7%) | 9 (22.5%) | 11 (37.9%) | 4 (26.7%) | 6 (75.0%) | 1 (33.3%) | 9 (60.0%) |
| [4–6] | 11 (22.9%) | 18 (34.6%) | 19 (47.5%) | 10 (34.5%) | 8 (53.3%) | 0 | 1 (33.3%) | 3 (20.0%) |
| >7 | 18 (37.5%) | 17 (32.7%) | 12 (30.0%) | 8 (27.6%) | 3 (20.0%) | 2 (25.0%) | 1 (33.3%) | 3 (20.0%) |
| Number of BTcP episodesd | N=48 | N=52 | N=40 | N=29 | N=15 | N=8 | N=3 | N=15 |
| Mean (SD) | 3.3 (2.9) | 3.3 (2.3) | 3.2 (1.9) | 3.4 (2.1) | 3.6 (1.9) | 2.2 (1.8) | 2.5 (0.9) | 2.2 (1.1) |
| Median (range) | 3.0 (0.0–15.0) |
3.0 (0.0–11.1) |
3.1 (0.0–7.5) |
3.3 (0.0–8.3) |
3.3 (0.3–6.0) |
2.0 (0.1–5.7) |
3.0 (1.5–3) |
2.0 (0.0–4.0) |
| Number of BTcP episodes by classd, n (%) | ||||||||
| ≤4 | 34 (85.0) | 33 (73.3) | 24 (66.7) | 17 (70.8) | 8 (61.5) | 6 (85.7) | 3 (100.0) | 14 (100.0) |
| >4 | 6 (15.0) | 12 (26.7) | 12 (33.3) | 7 (29.2) | 5 (38.5) | 1 (14.3) | 0 | 0 |
| Use of FPNS, n (%) | N=74 | N=55 | N=38 | N=22 | N=10 | N=1 | N=79 | |
| Yes | 70 (94.6) | 50 (90.9) | 31 (81.6) | 20 (90.9) | 9 (90.0) | 1 (100.0) | 60 (75.9) | |
| Not applicablec | 0 | 1 (1.8) | 3 (7.9) | 2 (9.1) | 1 (10.0) | 0 | 9 (11.4) | |
| Dose of FPNS/BTcP episode, µg | N=70 | N=50 | N=31 | N=20 | N=9 | N=1 | N=59 | |
| Median (range) | 100 (100–400) |
100 (100–400) |
100 (100–400) |
100 (100–400) |
100 (100–400) |
100 (100–800) |
Notes: Missing data: type of pain (W2, n=1; end of radiotherapy, n=1), causes of BTcP (W2, n=1), average duration of BTcP episodes (W2, n=1), intensity of BTcP episodes (Day 1, n=2; W2, n=1; W5, n=1); number of BTcP episodes (Day 1, n=10; W1, n=7; W2, n=5; W3, n=5; W5, n=2; W5, n=2; end of radiotherapy, n=1), dose of FPNS per BTcP episode (end of radiotherapy, n=1).aInvestigator initial assessment: enrollment visit; patient initial assessment: at first FPNS intake; bMultiple answers possible per patient; cTreatment discontinued since last visit; dBTcP episodes (treated or not with FPNS) within the last 24 hours.
Abbreviations: BTcP, breakthrough cancer pain; FPNS, fentanyl pectin nasal spray; SD, standard deviation; W, week.