Table 3.
Patient outcome (N=35)
| Outcome | Estimate |
|---|---|
| Best objective response | |
| Evaluablea | 27 (77%) |
| CR | 0 |
| PR | 1 (4%) |
| STAB | 9 (33%) |
| PROG | 17 (63%) |
| Confirmed CR/PR | 1 (4%) |
| Time to Progression | |
| Progressions | 27 |
| Medianb (95% CI) | 1.6 mos (1.4–2.2) |
| % Progression-Free | |
| 6 mos | 10% (3–32%) |
| 12 mos | 5% (1–30%) |
| Survival | |
| Deaths | 31 |
| Medianb (95%CI) | 6.0 mos (3.9–7.8) |
| % Alive | |
| 6 mos | 47% (33–67%) |
| 12 mos | 29% (17–50%) |
| 18 mos | 16% (7–36%) |
a
Patients having completed 6-week restaging or having disease progression prior to their initial 6-week restaging. Confidence intervals are based on all evaluable patients, while the final decision to discontinue the study was based on the first 20 evaluable patients and according to the study design
b
Kaplan-Meier method