Toxicity and efficacy outcomes of arm A and arm B at interim analysis
| . | Arm A (n = 21) . | Arm B (n = 21) . |
|---|---|---|
| Efficacy | ||
| No. of cycles, median (range) | 2 (1-10) | 1 (1-6) |
| No. (%) of patients receiving second cycle | 14 (67) | 9 (43) |
| Median OS, mo (range) | 12 (0.5-37.4) | 7 (0.6-22.5) |
| OS > 12 mo, no. (%) | 10 (48) | 7 (33) |
| CR, no. (%) | 7 (33) | 6 (29) |
| Median DFS, mo (range) | 11 (6.6-27.1) | 8 (2.2-21.2) |
| OS > 12 mo, no. (%) | 6 (86) | 5 (83) |
| Overall Toxicity Score, no. (%)* | ||
| 0 | 7 (33) | 4 (19) |
| 1 | 6 (29) | 5 (24) |
| 2 | 6 (29) | 5 (24) |
| 3 | 1 (5) | 2 (10) |
| 4 | 1 (5) | 5 (24) |
| No. (%) of Toxicity Score > 3 | 2 (10) | 7 (33) |
| No. (%) > grade 3 nonhematologic toxicities | 4 (19) | 7 (33) |
| No. (%) > grade 3 infection | 5 (24) | 8 (38) |
| Bloodstream | 4 | 1 |
| Lung | 1 | 7 |
| Fatal infection | 1 (5) | 4 (19) |
| . | Arm A (n = 21) . | Arm B (n = 21) . |
|---|---|---|
| Efficacy | ||
| No. of cycles, median (range) | 2 (1-10) | 1 (1-6) |
| No. (%) of patients receiving second cycle | 14 (67) | 9 (43) |
| Median OS, mo (range) | 12 (0.5-37.4) | 7 (0.6-22.5) |
| OS > 12 mo, no. (%) | 10 (48) | 7 (33) |
| CR, no. (%) | 7 (33) | 6 (29) |
| Median DFS, mo (range) | 11 (6.6-27.1) | 8 (2.2-21.2) |
| OS > 12 mo, no. (%) | 6 (86) | 5 (83) |
| Overall Toxicity Score, no. (%)* | ||
| 0 | 7 (33) | 4 (19) |
| 1 | 6 (29) | 5 (24) |
| 2 | 6 (29) | 5 (24) |
| 3 | 1 (5) | 2 (10) |
| 4 | 1 (5) | 5 (24) |
| No. (%) of Toxicity Score > 3 | 2 (10) | 7 (33) |
| No. (%) > grade 3 nonhematologic toxicities | 4 (19) | 7 (33) |
| No. (%) > grade 3 infection | 5 (24) | 8 (38) |
| Bloodstream | 4 | 1 |
| Lung | 1 | 7 |
| Fatal infection | 1 (5) | 4 (19) |
Overall Toxicity Scoring Criteria: 0 indicates no toxicity; 1, any toxicity (hospitalization < 10 days; fever/infection; grade 1 or 2 mucositis, elevated bilirubin, or creatinine; grade 1 neurotoxicity); 2, hospitalization > 10 days; grade 2 neurotoxicity; all other toxicities grade 3; 3, neurotoxicity > grade 3; all other toxicities grade 4; and 4, death.