TABLE 2.
Clinical outcome | No of patients (N = 26) | |
---|---|---|
Response rate (CR + PR) (%) [90% CI] | 30.8% | [18.3‐46.9] |
Disease control rate (CR + PR+SD) (%) [90% CI] | 80.8% | [65.4‐90.3] |
Median response duration, months [95% CI] | 4.3 mo | [2.3‐10.3] |
Median overall survival, months [95% CI] | 27.4 mo | [16.6‐34.3] |
1‐y survival rate, % | 76.9% |
Safety profile | |||||
---|---|---|---|---|---|
All grades (%) |
Grade 1 (%) |
Grade 2 (%) |
Grade 3 (%) |
Grade 4 (%) |
|
Hematological adverse events | |||||
White blood cell decreased | 8 (30.8) | 3 (11.5) | 2 (7.7) | 3 (11.5) | 0 (0) |
Neutrophil count decreased | 10 (38.4) | 4 (15.4) | 5 (19.2) | 1 (3.8) | 0 (0) |
Anemia | 4 (15.4) | 3 (11.5) | 1 (3.8) | 0 (0) | 0 (0) |
Platelet count decreased | 5 (19.2) | 5 (19.2) | 0 (0) | 0 (0) | 0 (0) |
Nonhematological adverse events | |||||
Diarrhea | 11 (42.3) | 10 (38.5) | 1 (3.8) | 0 (0) | 0 (0) |
Nausea | 8 (30.8) | 4 (15.4) | 4 (15.4) | 0 (0) | 0 (0) |
Aspartate aminotransferase increased | 8 (30.8) | 7 (26.9) | 1 (3.8) | 0 (0) | 0 (0) |
Skin rash | 8 (30.8) | 3 (11.5) | 2 (7.7) | 3 (11.5) | 0 (0) |
Fatigue | 6 (23.1) | 4 (15.4) | 1 (3.8) | 1 (3.8) | 0 (0) |
Anorexia | 6 (23.1) | 4 (15.4) | 2 (7.7) | 0 (0) | 0 (0) |
Alanine aminotransferase increased | 4 (15.4) | 3 (11.5) | 0 (0) | 1 (3.8) | 0 (0) |
Corneal ulcer | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
Febrile neutropenia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Abbreviation: CI, confidence interval.