| |
Day 0 |
Day 10 |
Day 28 |
|
| Weight Changes from Day 0 |
|
|
|
|
| 5-7.5% weight loss |
- |
13.6% (3/22) |
0% (0/21) |
|
| 7.5-10% |
- |
0% (0/22) |
11.1% (2/18) |
|
| > 10% |
- |
0% (0/22) |
5.6% (1/18) |
|
| total |
- |
13.6% (3/22) |
16.7% (3/18) |
- |
| Fever (≥ 103°F) |
0% (0/20) |
5.6% (1/18) |
5.6% (1/18) |
p = 0.26 |
| GI Toxicities |
|
|
|
|
| Anorexia |
17.4% (4/23) |
27.3 % (6/22) |
11.1% (2/18) |
p = 0.30 |
| Grade 1-2 |
3/23 |
4/22 |
0/18 |
|
| Grade 3-4 |
1/23 |
2/22 |
2/18 |
|
| Vomiting |
0% (0/23) |
0% (0/22) |
16.7% (3/18) |
p = 0.07 |
| Grade 1-2 |
0/23 |
0/22 |
3/18 |
|
| Grade 3-4 |
0/23 |
0/22 |
0/18 |
|
| Diarrhea |
8.7% (2/23) |
4.5% (1/22) |
11.1% (2/18) |
p = 0.64 |
| Grade 1-2 |
2/23 |
1/22 |
2/18 |
|
| Grade 3-4 |
0/23 |
0/22 |
0/18 |
|
| Hematologic Toxicities
(all grade ≤ 2) |
|
|
|
|
| Neutropenia |
0% (0/23) |
9.1% (2/22) |
11.8% (2/17) |
p = 0.07 |
| Thrombocytopenia |
0% (0/23) |
4.5% (1/22) |
0% (0/17) |
p = 0.31 |
| Lymphopenia |
0% (0/23) |
13.6% (3/22) |
11.8% (2/17) |
p = 0.07 |
| Renal Toxicity (Creatinine)
(all grade ≤ 2) |
4.3% (1/23) |
4.5% (1/22) |
0% (0/17) |
p = 1.0 |
| Hepatic Toxicity (ALT) |
17.4% (4/23) |
18.2% (4/22) |
17.6% (3/17) |
p = 0.71 |
| Grade 1-2 |
3/23 |
3/22 |
2/17 |
|
| Grade 3-4 |
1/23 |
1/22 |
1/17 |
|
|
