Table 2. Response rates according to RECIST criteria (ITT and PP populations).
ITT population
|
PP population
|
|||||||
---|---|---|---|---|---|---|---|---|
Capecitabine (N=46)
|
S-1 (N=45)
|
Capecitabine (N=44)
|
S-1 (N=45)
|
|||||
INV | EIR | INV | EIR | INV | EIR | INV | EIR | |
Response, n | ||||||||
CR | 2 | 0 | 1 | 1 | 2 | 0 | 1 | 1 |
PR | 11 | 12 | 11 | 12 | 11 | 12 | 11 | 12 |
SD | 19 | 18 | 20 | 18 | 19 | 18 | 20 | 18 |
PD | 8 | 10 | 9 | 10 | 8 | 10 | 9 | 10 |
NA | 6 | 6 | 4 | 4 | 4 | 4 | 4 | 4 |
ORR, n (%) | 12 (26.1) | 13 (28.9) | 12 (27.2) | 13 (28.9) | ||||
95% CI | 13.4–38.8 | 15.6–42.1 | 14.1–40.4 | 15.6–42.1 |
INV=investigator assessment; EIR=external independent review; ORR=overall response rate; CR=complete response; PR=partial response; SD=stable disease; PD=progressive disease; NA=not assessable; CI=confidence interval.