Table 3. Secondary Outcomes Between PPI vs No PPI Treated Within Trial Study Arm.
Secondary End Point | No. (%) | P Value | ||||
---|---|---|---|---|---|---|
Control Arm (CapeOx + Placebo) | P Value | Lapatinib Arm (CapeOx + Lapatinib) | ||||
No PPI (155) | PPI (119) | No PPI (161) | PPI (110) | |||
Objective response rate | 65 (42) | 43 (36) | .33 | 84 (52) | 60 (54) | .70 |
Disease control rate | 128 (83) | 84 (71) | .02 | 128 (80) | 92 (84) | .24 |
Capecitabine reductions | 47 (30) | 42 (36) | .38 | 72 (45) | 54 (49) | .48 |
Lapatinib reductions | NA | NA | NA | 39 (24) | 39 (35) | .06 |
Hand-foot syndrome | 22 (14) | 12 (10) | .32 | 33 (21) | 20 (18) | .43 |
Rash | 9 (6) | 7 (6) | .99 | 29 (18) | 16 (14) | .42 |
Diarrhea | 4 (3) | 5 (4) | .46 | 20 (12) | 13 (12) | .88 |
Abbreviations: CapeOx, capecitabine and oxaliplatin; NA, not applicable; PPI, proton pump inhibitors.