Table 1.
Sociodemographic / clinical characteristics of Part A and Part B patients of JAVELIN Merkel 200 trial, FACT-M PRO analysis set (n = 172)*
| Sociodemographic / clinical characteristics | Study part | p-value** | ||
|---|---|---|---|---|
| Part A (n = 70) |
Part B (n = 102) |
Total (n = 172) |
||
| Gender n (%) | ||||
| Male | 52 (74.3%) | 69 (67.6%) | 121 (70.3%) | 0.3490 |
| Female | 18 (25.7%) | 33 (32.4%) | 51 (29.7%) | |
| Age (years) | ||||
| Mean (SD) | 70.20 (11.19) | 72.53 (9.81) | 71.58 (10.42) | 0.1505 |
| Median | 73.00 | 73.50 | 73.00 | |
| Range | 33.00–88.00 | 45.00–93.00 | 33.00–93.00 | |
| Pooled geographic region n (%) | ||||
| North America | 40 (57.1%) | 27 (26.5%) | 67 (39.0%) | 0.0001 |
| Europe | 22 (31.4%) | 63 (61.8%) | 85 (49.4%) | |
| Rest of the World | 8 (11.4%) | 12 (11.8%) | 20 (11.6%) | |
| ECOG PS at baseline, n (%) | ||||
| ECOG PS 0 | 38 (54.3%) | 66 (64.7%) | 104 (60.5%) | 0.1697 |
| ECOG PS 1 | 32 (45.7%) | 36 (35.3%) | 68 (39.5%) | |
| Site of primary tumor, n (%) | ||||
| Non-skin | 9 (12.9%) | 7 (6.9%) | 16 (9.3%) | 0.1097 |
| Skin | 55 (78.6%) | 91 (89.2%) | 146 (84.9%) | |
| Not applicable | 0 (0.0%) | 4 (3.9%) | 4 (2.3%) | |
| Missing | 6 (8.6%) | 0 (0.0%) | 6 (3.5%) | |
| Tumor size at baseline (mm) | ||||
| n (missing) | 61 (9) | 100 (2) | 161 (11) | |
| Mean (SD) | 103.69 (79.68) | 79.46 (58.48) | 88.64 (68.09) | 0.0280 |
| Median | 83.00 | 64.00 | 66.00 | |
| Range | 16.00–404.00 | 0.00–288.00 | 0.00–404.00 | |
| Time since initial diagnosis (years) | ||||
| Mean (SD) | 2.19 (0.80) | 2.27 (0.76) | 2.24 (0.78) | 0.4631 |
| Median | 2.00 | 2.00 | 2.00 | |
| Min - Max | 1.00–3.00 | 1.00–3.00 | 1.00–3.00 | |
| Time since first metastatic disease (months) | ||||
| Mean (SD) | 16.94 (23.44) | 5.46 (7.66) | 10.13 (16.98) | <.0001 |
| Median | 9.49 | 2.33 | 5.73 | |
| Min - Max | 1.51–156.75 | 0.36–49.58 | 0.36–156.75 | |
ECOG PS = Eastern Cooperative Oncology Group Performance Status (0 = fully active; 1 = restricted in physically strenuous activity); SD = standard deviation;
*Of note, in the process of data cleaning of a subsequent Part B data cut, baseline data of four patients were set to missing as their assessment had taken place after treatment initiation. For the present analysis, however, it was deemed irrelevant that treatment had already started, as the psychometric properties of the FACT-M should not be influenced by assessment time point. Hence, these patients are included in the psychometric analyses, explaining discrepancies between the sample size reported herein and the sample size used for the analyses of HRQoL outcomes over time where n = 98 patients (instead of n = 102) are included in PAS of the FACT-M
** P-value for between-group comparisons: T-test for continuous variables, Chi2 or Fisher’s exact for categorical variables