1Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
2Seoul National University Cancer Research Institute, Seoul, Korea
3Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
4Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
5Hanmi Pharm. Co., Ltd., Seoul, Korea
6Department of Pathology, Seoul National University College of Medicine, Seoul, Korea
Copyright © 2018 by the Korean Cancer Association
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Characteristic | Intermittent dosing schedule (n=55) | Continuous dosing schedule (n=20) |
---|---|---|
Sex | ||
Male | 31 (56) | 13 (65) |
Female | 24 (44) | 7 (35) |
Age (yr) | 55 (25-83) | 55 (32-77) |
ECOG PS | ||
0 | 30 (55) | 8 (40) |
1 | 22 (40) | 12 (60) |
2 | 2 (4) | 0 |
3 | 1 (2) | 0 |
Cancer | ||
NSCLC | 22 (40) | 5 (25) |
Stomach | 10 (18) | 3 (15) |
Breast | 8 (15) | 2 (10) |
Colorectal | 9 (16) | 6 (30) |
Others | 6 (11) | 4 (20) |
Prior regimen | ||
1-2 | 9 (16) | 3 (15) |
3 | 9 (16) | 5 (25) |
≥ 4 | 37 (67) | 12 (60) |
TEAEs, preferred terms | Intermittent dosing schedule (n=55) |
Continuous dosing schedule (n=20) |
||
---|---|---|---|---|
Grade 1-4 | ≥ Grade 3 | Grade 1-4 | ≥ Grade 3 | |
Diarrhea | 48 (87) | 8 (15) | 20 (100) | 3 (15) |
Rash | 46 (84) | 1 (2) | 13 (65) | - |
Stomatitis | 40 (73) | - | 16 (80) | 1 (5) |
Pruritus | 33 (60) | - | 11 (55) | 1 (5) |
Decreased appetite | 20 (36) | 1 (2) | 11 (55) | 2 (10) |
Acne | 17 (31) | - | - | - |
Dermatitis acneiform | 2 (4) | - | 6 (30) | 2 (10) |
Palmar-plantar erythrodysaesthesia syndrome | 18 (33) | - | 3 (15) | - |
Rhinorrhea | 14 (26) | - | 6 (30) | - |
Paronychia | 13 (24) | - | 13 (65) | - |
Mucosal inflammation | 13 (24) | 1 (2) | 6 (30) | - |
Nausea | 11 (20) | 1 (2) | 4 (20) | - |
Vomiting | 10 (18) | 1 (2) | 4 (20) | - |
Fatigue | 8 (15) | - | 3 (15) | - |
Skin exfoliation | 8 (15) | - | - | - |
Dry skin | 6 (11) | - | 6 (30) | 2 (10) |
Weight decreased | 6 (11) | - | - | - |
Dose (mg) | Intermittent dosing schedule |
Continuous dosing schedule |
||||
---|---|---|---|---|---|---|
No. of patients | No. of DLTs | DLT details | No. of patients | No. of DLTs | DLT details | |
0.5 | 3 | - | - | - | - | - |
1 | 3 | - | - | - | - | - |
2 | 3 | - | - | - | - | - |
4 | 3 | - | - | - | - | - |
8 | 3 | - | - | - | - | - |
12 | 6 | 1 | Diarrhea | 3 | - | - |
16 | 6 | 1 | Diarrhea | - | - | - |
18 | - | - | - | 6 | 1 | Decreased appetite |
20 | 3 | - | - | - | - | - |
24 | 6 | 1 | Diarrhea | 3 | 1 | Diarrhea |
Drug compliance < 80% | ||||||
32 | 7 | 2 | Diarrhea | - | - | - |
24 Extension | 12 | 5 | 3 Diarrhea, 1 nausea, 1 mucosal inflammation | - | - | - |
Values are presented as number (%) or median (range). ECOG PS, Eastern Cooperative Oncology Group performance status; NSCLC, non-small cell lung cancer.
Values are presented as number (%). TEAEs, treatment-emergent adverse events.
DLT, dose-limiting toxicity.