Table 1.
Baseline patient characteristics
| FPNS N=12 (%)a |
Placebo N=12 (%)a |
All patients N=24 (%)a |
|
|---|---|---|---|
| Average age (range) | 51.5 (44.7, 58.3) | 53.3 (45.0, 61.6) | 52.4 (47.5, 57.4) |
| Female sex | 9 (75.0) | 4 (33.3) | 13 (54.2) |
| Race | |||
| Caucasian | 8 (66.7) | 8 (66.7) | 16 (66.7) |
| Black | 3 (25) | 2 (16.7) | 5 (20.8) |
| Hispanic | 1 (8.3) | 2 (16.7) | 3 (12.5) |
| Education | |||
| High school or less | 4 (33.3) | 2 (16.7) | 6 (25.0) |
| College | 8 (66.7) | 7 (58.3) | 15 (62.5) |
| Advanced degree | 0 | 3 (25.0) | 3 (12.5) |
| Cancer type | |||
| Breast | 3 (25.0) | 2 (16.7) | 5 (20.8) |
| Gastrointestinal | 2 (16.7) | 4 (33.3) | 6 (25.0) |
| Genitourinary | 2 (16.7) | 0 | 2 (8.3) |
| Gynecologic | 2 (16.7) | 0 | 2 (8.3) |
| Lung | 1 (8.3) | 2 (16.7) | 3 (12.5) |
| Hematologic | 0 | 2 (16.7) | 2 (8.3) |
| Others | 2 (16.7) | 2 (16.7) | 4 (16.7) |
| Cancer stage | |||
| Metastatic/refractory | 8 (66.7) | 10 (83.4) | 18 (75.0) |
| Localized/Locally advanced | 4 (33.3) | 2 (16.6) | 6 (25.0) |
| *Cancer Dyspnea Scale, mean (SD) | |||
| Effort | 6.3 (3.7) | 4.6 (2.7) | 5.5 (3.3) |
| Anxiety | 3.6 (3.0) | 2.3 (3.7) | 3.0 (3.4) |
| Discomfort | 2.8 (1.5) | 2.4 (1.4) | 2.6 (1.4) |
| Total | 12.8 (7.1) | 9.3 (5.8) | 11.1 (6.6) |
| Average dyspnea NRS during breakthrough episodes over the last week, mean (SD) |
4.4 (1.4) | 4 (1.0) | 4.2 (1.2) |
| Co-morbidities | |||
| COPD | 2 (16.7) | 2 (16.7) | 4 (16.7) |
| Heart failure | 1 (8.3) | 0 | 1 (4.2) |
| Asthma | 5 (41.7) | 0 | 5 (20.8) |
| Bronchiectasis | 0 | 0 | 0 |
| Concurrent therapies | |||
| Opioids | 12 (100.0) | 12 (100.0) | 24 (100.0) |
| Bronchodilators | 6 (50.0) | 5 (41.7) | 11 (45.8) |
| Steroids | 0 | 0 | 0 |
| Supplemental oxygen | 1 (8.3) | 1 (8.3) | 2 (8.3) |
| Morphine equivalent daily doses, median (interquartile range) in mg |
137.5 (125, 200) | 175 (135, 325) | 158 (133, 235) |
| Karnofsky performance status, mean (SD) |
75.8 (9.0) | 75.8 (10.8) | 75.8 (9.7) |
Abbreviations: COPD, chronic obstructive pulmonary disease; NRS, numeric rating scale; SD, standard deviation
a
unless otherwise specified