Table 3.
Disease Response and Duration of Treatment
| Characteristic | Overall (n = 35) n (%) | Arm A (n = 17) n (%) | Arm B (n = 18) n (%) |
| Tumor Response | |||
| Evaluable | |||
| Partial Response | 2 (6) | 0 | 2 (11) |
| Stable Disease | 13 (37) | 5 (29) | 8 (44) |
| Progressive Disease | 17 (49) | 11 (65) | 6 (33) |
| Not Evaluable – Off too early | 3 (9) | 1 (6) | 2 (11) |
| Observed Response Rate | |||
| % (95% CI) | 6% (1–19%) | 0% (0–20%) | 11% (1–35%) |
| Cycles Received | |||
| Median | 2 | 2 | 3 |
| Rangea | 1–25 | 1–25 | 1–8 |
| Number≥4 Cycles | 14 (40) | 5 (29) | 9 (50) |
| Reason Off Treatment | |||
| Progression | 26 (74) | 14 (82) | 12 (67) |
| Early Death | 1 (3) | 0 | 1 (6) |
| Toxicity | 1 (3) | 1 (6) | 0 |
| Patient Decision | 5 (14) | 2 (12) | 3 (17) |
| Intercurrent Illness | 1 (3)b | 0 | 1 (6) |
| Still Ona | 1 (3) | 0 | 1 (6) |
| Progression-Free Survival (months) | |||
| Median (95% confidence interval) | 2.9 (2.6–8.4) | 2.7 (2.3–4.7) | 5.2 (2.7–10.8) |
a1 patient on Arm B (on for 21 cycles) is still on treatment and is not included in these ranges. bPatient’s renal function declined unrelated to treatment, required dialysis and became ineligible for further treatment.