Table 1. Baseline Patient Characteristics.
| Dexamethasone n=20 n (%)a |
Placebo n=21 n (%)a |
Total N=41 n (%)a |
|
|---|---|---|---|
| Average age (range) | 62 (49-71) | 64 (48-78) | 63 (48-78) |
| Female sex | 11 (55) | 14 (67) | 25 (61) |
| Race | |||
| Caucasian | 14 (70) | 13 (62) | 27 (66) |
| Black | 5 (25) | 6 (29) | 11 (27) |
| Hispanic | 1 (5) | 1 (5) | 2 (5) |
| Asian | 0 | 1 (5) | 1 (2) |
| Education | |||
| High school or less | 16 (80) | 18 (86) | 34 (83) |
| Some college | 1 (5) | 3 (14) | 4 (10) |
| Completed college | 3 (15) | 0 | 3 (7) |
| Cancer type | |||
| Mesothelioma | 1 (5) | 3 (14) | 4 (10) |
| Non-small cell lung cancer | 14 (70) | 17 (81) | 31 (76) |
| Small cell lung cancer | 2 (10) | 0 | 2 (5) |
| Other | 3 (15) | 1 (5) | 4 (10) |
| Cancer stage | |||
| Localized | 4 (20) | 1 (5) | 5 (12) |
| Locally advanced | 3 (15) | 4 (19) | 7 (17) |
| Metastatic/recurrent | 13 (65) | 16 (76) | 29 (71) |
| Comorbidities | |||
| COPD | 2 (10) | 7 (33) | 9 (22) |
| Asthma | 1 (5) | 2 (10) | 3 (7) |
| Concurrent therapies | |||
| Opioids, regular b | 6 (30) | 9 (43) | 15 (37) |
| Opioids, as needed | 9 (45) | 11 (52) | 20 (49) |
| Bronchodilators, regular | 1 (5) | 3 (14) | 4 (10) |
| Bronchodilators, as needed | 4 (20) | 4 (19) | 8 (20) |
| Supplemental oxygen, regular | 0 | 3 (14) | 3 (7) |
| Supplemental oxygen, as needed | 0 | 1 (5) | 1 (2) |
| Reasons for dyspnea c | |||
| Lung parenchymal lesions | 12 (60) | 11 (52) | 23 (56) |
| Post-radiation changes | 8 (40) | 6 (29) | 14 (34) |
| Pleural effusion | 4 (20) | 8 (38) | 12 (29) |
| Obstructive intrinsic lung disease | 5 (25) | 6 (29) | 11 (27) |
| Post-surgical changes | 4 (20) | 1 (5) | 5 (13) |
| Pleural lesions | 1 (5) | 5 (24) | 6 (15) |
| Other | 0 | 2 (10) | 2 (5) |
| Karnofsky Performance Status, mean (SD) | 74 (11) | 71 (11) | 72 (11) |
| Bedside spirometry measures | |||
| FEV1 | 1.7 (0.5) | 1.4 (0.6) | 1.6 (0.6) |
| FEV1 % predicted | 58.7 (17.1) | 55.1 (18.1) | 56.9 (17.5) |
| FVC | 2.4 (0.8) | 1.9 (0.7) | 2.2 (0.8) |
| FVC % predicted | 62.8 (15) | 55.4 (19) | 59.2 (17.2) |
| FEV1/FVC ratio (%) | 73.6 (13) | 75.6 (16.1) | 74.5 (14.4) |
COPD = chronic obstructive pulmonary disease; ECOG = Eastern Oncology Cooperative Group; NRS = numeric rating scale; SD = standard deviation
a
Unless otherwise specified
b
Only one patient in the placebo group had an increase in opioid during the first seven days of the study.
c
Some patients have more than one reason for dyspnea. If patients had a clinical diagnosis of radiation-induced fibrosis requiring systemic steroids, they were not eligible for this study.
However, some patients without this clinical diagnosis had variable degrees of fibrotic change in the lungs labeled as post-radiation changes, which may be contributing to dyspnea.