Table 5 Comparison between the current Japanese study and CONKO-001
Current study (JSAP-02) | CONKO-001 a | |||||
|---|---|---|---|---|---|---|
Gemcitabine | Surgery-only | Gemcitabine | Surgery-only | |||
Study design | ||||||
Planned sample size | 116 | 368 | ||||
Planned number of gemcitabine cycles | 3 | — | 6 | — | ||
Planned weeks from surgery to randomisation | ⩽10 | ⩽6 | ||||
Selection based on postoperative tumour markers | No requirement | ⩽2.5 times the upper limit of normal | ||||
Baseline patient characteristics | ||||||
No. of patients | 58 | 60 | 179 | 175 | ||
Median age (years) | 65 | 64 | 62 | 61 | ||
Sex: men | 69% | 57% | 59% | 56% | ||
Median Karnofsky PS | 90 | 90 | 80 | 80 | ||
Resection status: R0 | 81% | 87% | 81% | 85% | ||
Nodal status: N0 | 33% | 30% | 29% | 27% | ||
Median days from surgery to randomisation | 44 | 47 | 22 | 24 | ||
Results | ||||||
Median DFS (months) | 11.4 | 5.0 | 13.4 | 6.9 | ||
1-year DFS rate | 49% | 27% | 58% | 31% | ||
2-year DFS rate | 27% | 17% | 31% | 15% | ||
P-value | 0.01 | <0.01 | ||||
Median OS (months) | 22.3 | 18.4 | 22.1 | 20.2 | ||
1-year OS rate | 78% | 75% | 73% | 73% | ||
2-year OS rate | 48% | 40% | 48% | 42% | ||
5-year OS rate | 24% | 11% | 23% | 12% | ||
P-value | 0.19 | 0.06 | ||||
