Table 2:
Comparison of gemcitabine arm of RTOG 97-04 trial and gemcitabine arm of CONKO-1 trial.
| RTOG 97-0424 | CONKO-11 | |
|---|---|---|
| Treatment | 1 cycle gemcitabine
→ 5-FU/RT → 4 cycles gemcitabine |
6 cycles gemcitabine |
|
Patient characteristics | ||
| Positive margins | 34% | 19% |
| CA 19-9 >90 U/mL | 79% | 100% |
| Node-positive | 66% | 71% |
| T3/4 | 75% | 86% |
|
Disease control | ||
| 3-year OS, all patients | 33% | 30%a |
| 3-year OS in patients with CA 19-9 <90 U/mL | 31% | 30%a |
| Median survival, all patients | 20.5 mo | 22.1 mo |
| Median survival in patients with CA 19-9 <90 U/mL | 22.8 mo | 22.1 mo |
| Local recurrence rate | 23% | 25% |
| Distant metastasis rate | 75% | 67% |
|
Toxicity | ||
| Any grade 3 or higher | 79% | 14.5%b |
| Hematologic grade 3 or higher | 58% | 4% |
| Nonhematologic grade 3 or higher | 58% | 3.5% |
Abbreviations: mo = month; OS = overall survival.
a
Estimated survival.
b
Serious adverse event, grade not specified.