Table 2. Drug delivery and reasons for treatment discontinuation.
| Treatment group † | ||
|---|---|---|
| D3P | M3P | |
| No. of patients | 113 | 115 |
| No. of patients receiving study medicine | 111 | 109 |
| No. of total cycles received | 786 | 529 |
| Median cycles received by patient | 8 | 4 |
| Median cumulative dose, mg/m2 | 567.18 | 46.58 |
| No. of patients with dose reduction* (n%) | 21(18.92%) | 11(10.09%) |
| One dose reduction | 13(11.71%) | 9(8.26%) |
| Two dose reduction | 8(7.21%) | 2(1.83%) |
| No. of total cycles delayed # (n%) | 181(23.03%) | 126(23.82%) |
| Adverse effect unrelated to study medicine | 14(1.78%) | 4 (0.76%) |
| Hematologic toxicity | 15(1.91%) | 23 (4.35%) |
| Non-hematologic toxicity | 10(1.27%) | 10 (1.89%) |
| Hematologic and non-hematologic toxicity | 1(0.13%) | 3 (0.57%) |
| Others | 141(17.94%) | 86 (16.26%) |
| Reasons for treatment discontinuation (n%) | ||
| Completed treatment | 50(44.25%) | 27(23.48%) |
| Progressive disease or death | 33(29.20%) | 43(37.39%) |
| Adverse event | 9(7.96%) | 19(16.52%) |
| Lost to follow-up | 3(2.65%) | 4(3.48%) |
| Other therapy not permitted | 2(1.77%) | 2(1.74%) |
| Consent withdrawn | 1(0.88%) | 0(0.00%) |
| Decline to continue further treatment | 15(13.27%) | 20(17.39%) |
† Because of rounding, not all percentages total 100.
* No more than 2 dose reductions would be implemented per patient.
# Treatment could be delayed no more than 2 weeks.