Column No. | Total | Q2W | Q2W, male | MM | MM, Q2W | MM, Q2W, male | |
---|---|---|---|---|---|---|---|
Cases of analysis for SD or PFS Outcome | 23 cases (SD/PFS) | 17 Cases (SD) 18 Cases (PFS) | Male 14 Cases (SD / PFS) | Malignant Mesothelioma 17 Cases (SD) 18Cases (PFS) | Malignant Mesothelioma 11 Cases (SD) 12 Cases (PFS) | Malignant Mesothelioma Male 9 Cases (SD/PFS) | |
Cases with Administration Frequency | Cases with Q2W | 17 | 17 or 18 | 14 | 11 or 12 | 11 or 12 | 9 |
Cases with Q1W | 6 | 0 | 0 | 6 | 0 | 0 | |
Outcome: SD Index: Cut-off titer with variation of serum sCD26(%) titer from baseline | sCD26 measured point | Day29 Pre | Day29 Pre | Day29 Pre | Day29 Post | Day29 Post | Day29 Pre |
Index: Cut-off values | 46.4 | 46.4 | 37.7 | 18.2 | 18.2 | 37.7 | |
AUC | 0.795 | 0.888 | 1.000 | 0.736 | 0.733 | 1.000 | |
Sensitivity(%) | 91.7 (11/12) | 87.5 (7/8) | 100.0 (5/5) | 55.6 (5/9) | 60.0 (3/5) | 100.0 (3/3) | |
1-Specificity(%) | 27.3 (3/11) | 11.1 (1/9) | 0.0 (0/9) | 0.0 (0/8) | 0.0 (0/6) | 0.0 (0/6) | |
Fisher’s Exact Test | P = 0.003 ** | P = 0.003 ** | P < 0.001 ** | P = 0.029 * | P = 0.061 † | P = 0.012 * | |
PPV | 0.786 | 0.875 | 1.000 | 1.000 | 1.000 | 1.000 | |
NPV | 0.889 | 0.889 | 1.000 | 0.667 | 0.750 | 1.000 | |
Outcome: PFS > 90 Index: Cut-off titer with variation of serum sCD26(%) titer from baseline | sCD26 measured point | Day29 Post | Day29 Pre | Day29 Pre | Day29 Post | Day29 Post | Day29 Pre |
Index: Cut-off values | 18.2 | 46.4 | 37.7 | 18.2 | 18.2 | 37.7 | |
AUC | 0.692 | 0.917 | 0.950 | 0.708 | 0.812 | 1.000 | |
Sensitivity(%) | 62.5 (5/8) | 100.0 (6/6) | 100.0 (4/4) | 66.7 (4/6) | 75.0 (3/4) | 100.0 (3/3) | |
1-Specificity(%) | 6.7 (1/15) | 16.7 (2/12) | 10.0 (1/10) | 8.3 (1/12) | 0.0 (0/8) | 0.0 (0/6) | |
Fisher’s Exact Test | P = 0.009 ** | P = 0.002 ** | P < 0.001 ** | P = 0.022 * | P = 0.018 * | P = 0.012 * | |
PPV | 0.833 | 0.750 | 0.800 | 0.800 | 1.000 | 1.000 | |
NPV | 0.824 | 1.000 | 1.000 | 0.846 | 0.889 | 1.000 | |
Outcome: PFS > 180 Index: Cut-off titer with variation of serum sCD26(%) titer from baseline | sCD26 measured point | Day29 Post | Day29 Pre | Day29 Pre | Day29 Post | Day29 Post | Day29 Pre |
Index: Cut-off values | 18.2 | 46.4 | 37.7 | 18.2 | 18.2 | 37.7 | |
AUC | 0.759 | 0.846 | 0.879 | 0.815 | 1.000 | 0.929 | |
Sensitivity(%) | 71.4 (5/7) | 100.0 (5/5) | 100.0 (3/3) | 80.0 (4/5) | 100.0 (3/3) | 100.0 (2/2) | |
1-Specificity(%) | 6.3 (1/16) | 23.1 (3/13) | 18.2 (2/11) | 7.7 (1/13) | 0.0 (0/9) | 14.3 (1/7) | |
Fisher’s Exact Test | P = 0.003 ** | P = 0.007 ** | P = 0.027 * | P = 0.008 ** | P = 0.005 ** | P = 0.083 † | |
PPV | 0.833 | 0.625 | 0.600 | 0.800 | 1.000 | 0.667 | |
NPV | 0.882 | 1.000 | 1.000 | 0.923 | 1.000 | 1.000 |