Table 2.
Patient Characteristics and Provider Assessment of Acute Mucositis in Patients who Completed the Baseline QoL Questionnaire, Stratified by Treatment Arm
| GM-CSF (n=53) |
Placebo (n=50) |
|||
|---|---|---|---|---|
| Patient Clinical Characteristics | ||||
| Primary Disease Site, no., % | n=53 | n=50 | ||
| Oral cavity | 10 | 18.9% | 14 | 28.0% |
| Nasopharynx | 2 | 3.8% | 1 | 2.0% |
| Oropharynx | 27 | 50.9% | 20 | 40.0% |
| Hypopharynx | 1 | 1.9% | 3 | 6.0% |
| Supraglottic larynx | 8 | 15.1% | 5 | 10.0% |
| Glottic larynx | 2 | 3.8% | 1 | 2.0% |
| Not specified | 3 | 5.7% | 6 | 12.0% |
| KPS, no., % | n=53 | n=50 | ||
| 60 | 1 | 1.9% | 0 | 0.0% |
| 70 | 5 | 9.4% | 5 | 10.0% |
| 80 | 6 | 11.3% | 9 | 18.0% |
| 90 | 30 | 56.5% | 18 | 36.0% |
| 100 | 11 | 20.8% | 18 | 36.0% |
| Tumor (T) stage, no., % | n=53 | n=50 | ||
| T0 | 0 | 0.0% | 2 | 4.0% |
| T1 | 7 | 13.2% | 9 | 18.0% |
| T2 | 20 | 37.7% | 13 | 26.0% |
| T3 | 16 | 30.2% | 10 | 20.0% |
| T4 | 7 | 13.2% | 11 | 22.0% |
| TX | 2 | 3.8% | 5 | 10.0% |
| Not applicable | 1 | 1.9% | 0 | 0.0% |
| Nodal (N) stage, no., % | n=53 | n=50 | ||
| N0 | 17 | 32.1% | 13 | 26.0% |
| N1 | 8 | 15.1% | 7 | 14.0% |
| N2A | 6 | 11.3% | 5 | 10.0% |
| N2B | 14 | 26.4% | 15 | 30.0% |
| N2C | 5 | 9.4% | 7 | 14.0% |
| N3 | 2 | 3.8% | 3 | 6.0% |
| Not applicable | 1 | 1.9% | 0 | 0.0% |
| Concurrent Cisplatin, no., % | n=52 | n=49 | ||
| No | 44 | 84.6% | 45 | 91.8% |
| Yes | 8 | 15.4% | 4 | 8.2% |
| Oral Supplements at Study Entry, no., % | n=53 | n=50 | ||
| No | 45 | 84.9% | 44 | 88.0% |
| Yes | 7 | 13.2% | 6 | 12.0% |
| Unknown | 1 | 1.9% | 0 | 0.0% |
| Feeding Tube at Study Entry, no., % | n=53 | n=50 | ||
| No | 45 | 84.9% | 38 | 76.0% |
| Yes | 8 | 15.1% | 12 | 24.0% |
| Patient Demographics | ||||
| Age, years | n=53 | n=50 | ||
| Mean | 58.6 | 59.8 | ||
| Standard Deviation | 11.7 | 10.6 | ||
| Gender, no., % | n=53 | n=50 | ||
| Male | 41 | 77.4% | 33 | 66.0% |
| Female | 12 | 22.6% | 17 | 34.0% |
| Race/Ethnicity, no., % | n=53 | n=50 | ||
| White, non-Hispanic | 45 | 84.9% | 42 | 84.0% |
| Other | 8 | 15.1% | 8 | 16.0% |
| Country of Residence, no., % | n=53 | n=50 | ||
| USA | 46 | 86.8% | 42 | 84.0% |
| Canada | 7 | 13.2% | 8 | 16.0% |
| Partner Status, no., % | n=49 | n=48 | ||
| Single/Widowed/Divorced | 26 | 53.1% | 20 | 41.7% |
| Married/Live-in Partner | 23 | 46.9% | 28 | 58.3% |
| Highest Education Completed, no., % | n=46 | n=46 | ||
| No HS | 7 | 15.2% | 4 | 8.7% |
| Some HS | 10 | 21.7% | 13 | 28.3% |
| HS/GED/VocTech | 16 | 34.8% | 18 | 39.1% |
| At least some college | 13 | 28.3% | 11 | 23.9% |
| Smoking History, no., % | n=46 | n=46 | ||
| Never | 10 | 21.7% | 5 | 10.9% |
| Quit >1 yr ago | 11 | 23.9% | 15 | 32.6% |
| Quit <=1 yr ago | 13 | 28.3% | 14 | 30.4% |
| Current | 12 | 26.1% | 12 | 26.1% |
| Provider Assessment of Worst Acute Mucositis During Radiation Treatment | ||||
| Worst acute mucositis (Mucosal injury tool) | n=50 | n=50 | ||
| Median | 1.11 | 1.5 | ||
| Min – Max | 0.00 – 4.00 | 0.00 – 5.44 | ||
| Worst acute mucositis (NIH-CTC v2.0), no., % | n=49 | n=50 | ||
| Grade 0 | 1 | 2.0% | 3 | 6.0% |
| Grade 1 | 7 | 14.3% | 7 | 14.0% |
| Grade 2 | 18 | 36.7% | 16 | 32.0% |
| Grade 3 | 22 | 44.9% | 21 | 42.0% |
| Grade 4 | 1 | 2.0% | 3 | 6.0% |
Patients completed baseline and at least 1 follow-up questionnaire
No significant between-arm differences