Table 1.
Baseline tumor CXCR4 expression by IHC and CTC counts and CXCR4 expression in CTCs (%CXCR4+ CTC) at baseline and post-treatment by treatment arm or overall study population
| Biomarker | LY2510924 + CE (N = 47) |
CE (N = 42) |
Total (N = 89) |
|---|---|---|---|
| CXCR4+ Tumor Tissue | |||
| Baseline | |||
| Patients with evaluable results, n | 36 | 33 | 69 |
| Mean H-score (SD) | 205.8 (80.4) | 199.8 (85.2) | 203.0 (82.2) |
| Median H-score (range) | 200.0 (20, 300) | 200.0 (5, 300) | 200.0 (5, 300) |
| P-value* | 0.808 | ||
| CTC Count | |||
| Baseline | |||
| Patients with evaluable results, n | 42 | 36 | 78 |
| Mean (SD) | 615.5 (1419.4) | 1125.7 (3865.7) | 851.0 (2816.2) |
| Median (range) | 20.5 (0, 7153) | 98.5 (0, 21,428) | 51.0 (0, 21,428) |
| P-value* | 0.262 | ||
| Patients with CTC, n/N (%) | 33/42 (78.6) | 32/36 (88.9) | 65/78 (83.3) |
| Cycle 1, day 7 | |||
| Patients with evaluable results, n | 32 | 30 | 62 |
| Mean (SD) | 118.2 (461.3) | 57.4 (156.1) | 88.8 (347.3) |
| Median (range) | 4.0 (0, 2624) | 2.5 (0, 594) | 2.5 (0, 2624) |
| Patients with CTC, n/N (%) | 23/32 (71.9) | 19/30 (63.3) | 42/62 (67.7) |
| Cycle 2, day 1 | |||
| Patients with evaluable results, n | 34 | 27 | 61 |
| Mean (SD) | 70.6 (209.3) | 25.1 (79.9) | 50.5 (165.5) |
| Median (range) | 1.5 (0, 875) | 0.0 (0, 406) | 0.0 (0, 875) |
| Patients with CTC, n/N (%) | 18/34 (52.9) | 12/27 (44.4) | 30/61 (49.2) |
| 30-day follow-up | |||
| Patients with evaluable results, n | 29 | 25 | 54 |
| Mean (SD) | 128.5 (476.3) | 5.2 (18.1) | 71.4 (351.9) |
| Median (range) | 0.0 (0, 2008) | 0.0 (0, 87) | 0.0 (0, 2008) |
| Patients with CTC, n/N (%) | 14/29 (48.3) | 9/25 (36.0) | 23/54 (42.6) |
| %CXCR4+ CTCs | |||
| Baseline | |||
| Patients with evaluable results, n | 37 | 33 | 70 |
| Mean (SD) | 21.0 (26.3) | 26.6 (24.7) | 23.6 (25.5) |
| Median (range) | 10.9 (0.0, 100.0) | 21.1 (0.0, 100.0) | 17.8 (0.0, 100.0) |
| P-value* | 0.182 | ||
| Cycle 1, day 7 | |||
| Patients with evaluable results, n | 29 | 27 | 56 |
| Mean (SD) | 0.1 (0.2) | 9.2 (17.5) | 4.4 (12.9) |
| Median (range) | 0.0 (0.0, 1.0) | 0.0 (0.0, 58.3) | 0.0 (0.0, 58.3) |
| Cycle 2, day 1 | |||
| Patients with evaluable results, n | 33 | 24 | 57 |
| Mean (SD) | 7.9 (15.0) | 10.6 (19.7) | 9.1 (17.0) |
| Median (range) | 0.0 (0.0, 50.0) | 0.0 (0.0, 66.6) | 0.0 (0.0, 66.7) |
| 30-day follow-up | |||
| Patients with evaluable results, n | 29 | 23 | 52 |
| Mean (SD) | 4.1 (13.2) | 8.7 (28.8) | 6.1 (21.4) |
| Median (range) | 0.0 (0.0, 50.0) | 0.0 (0.0, 100.0) | 0.0 (0.0, 100.0) |
CE Carboplatin-etoposide, CTC Circulating tumor cell, CXCR4 Chemokine (C-X-C motif) receptor 4, IHC Immunohistochemistry, N number of patients, n Number of patients in a category, SD Standard deviation
*P-value from 2-sample, 2-sided Mann-Whitney of null hypothesis that baseline values were same for treatment arms