Table 4.
Current study | INT-0116 | |
---|---|---|
Patient population | ||
Median age, yrs | 63 | 60 |
Male, % | 60 | 72 |
T3-T4, % | 77 | 68 |
N+, % | 85 | 85 |
Toxicity | ||
Most common toxicities | Hem. + GI | Hem. + GI |
Grade 3 toxicity | 35% | 41% |
Grade 4 toxicity | 22% | 32% |
Hospitalizations | 32% | NA |
Toxic deaths | 1.8% | 1% |
Discontinuation due to toxicity | 36% | 31% |
efficacy1 | ||
3-year-DFS | 60% | 48% |
3-year-OS | 61% | 50% |
Proportion of distant relapses2 | 60% | 65% |
Hem. = hematological, GI = gastrointestinal, DFS = disease free survival, OS = overall survival.
1Efficacy data from the current study is limited only to patients undergoing R0 resection.
2Proportion of distant relapses out of all relapses, including those combined with locoregional relapses.