Table 4.
Efficacy Results According to Treatment Arm
| Efficacy | Arm A: Gemcitabine/Cisplatin (n = 56) |
Arm B: FDR Gemcitabine (n = 43) |
Arm C: Gemcitabine/Docetaxel (n = 57) |
Arm D: Gemcitabine/Irinotecan (n = 51) |
||||
|---|---|---|---|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | |
| Radiologic response (RECIST) | ||||||||
| Complete response* | 1 | 2 | 0 | 0 | 1 | 2 | ||
| Partial response* | 6 | 11 | 6 | 14 | 7 | 12 | 6 | 12 |
| Stable disease | 30 | 54 | 25 | 58 | 30 | 53 | 28 | 55 |
| Progressive disease | 19 | 34 | 12 | 28 | 20 | 35 | 16 | 31 |
| CA 19-9 response | 15/46† | 33 | 16/38 | 42 | 19/48 | 42 | 16/48 | 33 |
| Time to tumor progression, months | ||||||||
| Median | 4.5 | 3.3 | 4.1 | 4.0 | ||||
| 95% CI | 2.6 to 5.5 | 2.7 to 4.6 | 2.4 to 4.9 | 2.5 to 5.2 | ||||
| Patients alive at 6 months | 33 | 53 | 33 | 57 | 35 | 54 | 34 | 57 |
| Overall survival, months | ||||||||
| Median | 6.7 | 6.4 | 6.4 | 7.1 | ||||
| 95% CI | 5.0 to 7.8 | 4.4 to 9.9 | 5.1 to 7.9 | 5.4 to 8.8 | ||||
Abbreviations: FDR, fixed dose rate; RECIST, Response Evaluation Criteria in Solid Tumors.
*
Confirmed.
†
No. of patients/total No. of patients.