Events | Standard regimen | Modified regimen | |||
---|---|---|---|---|---|
Conroy et al. [5] | Yoshida et al. [11] | Stein et al. [14] | Li et al. [15] | Present study | |
Patients (n) | 171 | 31 | 68 | 62 | 65 |
Disease (n) | |||||
Locally advanced | 0 | 0 | 31 | 0 | 0 |
Metastatic | 171 | 31 | 37 | 62 | 65 |
ECOG performance score (n) | |||||
0 | 64 | 25 | 17 | 38 | 21 |
1 | 106 | 6 | 20 | 24 | 38 |
2 | 1 | 0 | 0 | 0 | 6 |
Dose (mg/m2) | |||||
Oxaliplatin | 85 | 85 | 85 | 68 | 65 |
Irinotecan | 180 | 150 | 135 | 135 | 150 |
5-Fluorouracil | 2400 | 2400 | 2400 | 2400 | 2400 |
Survival (months) | |||||
Median OS | 11.1 | 14.9 | 10.2 | 10.3 | 10.9 |
Median PFS | 6.4 | 7 | 6.1 | 7 | 6.7 |
Response (n) | |||||
Complete response | 1 | 0 | 0 | 0 | 0 |
Partial response | 53 | 12 | 13 | 13 | 21 |
Stable disease | 66 | 11 | 19 | 11 | 27 |
Progressive disease | 26 | 8 | 5 | 16 | 16 |
Objective response rate (%) | 31.6 | 38.7 | 35.1 | 32.5 | 32.3 |
Disease control rate (%) | 70.2 | 74.2 | 86.5 | 60 | 73.8 |
Adverse event (%) | |||||
Neutropenia (grade 3/4) | 45.7 | 83.9 | 12.2 | 29 | 12.4 |
Fatigue (grade 3/4) | 23.6 | NE | 12.2 | 0 | 0 |
Diarrhea (grade 3/4) | 12.7 | 6.5 | 16.2 | 0 | 6.2 |
Vomiting (grade 3/4) | 14.5 | 3.2 | 2.7 | 0 | 1.5 |
Sensory neuropathy (grade 3/4) | 9 | 9.7 | 2.7 | 0 | 0 |
Sensory neuropathy (grade 1/2) | NE | 58.1 | NE | 0 | 32.3 |