Table 4.
Selected toxicity during PE-based chemotherapy.
| Number of patients, (%) | ||
|---|---|---|
| Any Grade | Grade 3/4 | |
| Hematological toxicity | ||
| Leukopenia | 21 (35.6) | 7 (11.7) |
| Neutropenia | 16 (27.1) | 5 (6.9) |
| Febrile neutropenia | 0 (0) | 0 (0) |
| Anemia | 16 (27.1) | 3 (5.1) |
| Thrombocytopenia | 7 (11.9) | 0 (0) |
| Non-hematological toxicity | ||
| AST elevation | 13 (22) | 0 (0) |
| ALT elevation | 9 (15.3) | 0 (0) |
| Enterocolitis | 3 (5.1) | 1 (1.7) |
| Diarrhea | 3 (5.1) | 0 (0) |
| Mucositis | 15 (25.4) | 4 (6.8) |
| Nausea | 6 (10.2) | 0 (0) |
| Fatigue | 21 (35.6) | 1 (1.7) |
| Skin reactions* | 45 (76.3) | 3 (5.1) |
| Peripheral neuropathy | 15 (25.4) | 0 (0) |
| Pneumonia | 6 (10.2) | 4 (6.8) |
| Hypomagnesemia | 5 (8.5) | 1 (1.7) |
| Hypokalemia | 2 (3.4) | 1 (1.7) |
| Infusion reaction/anaphylaxis | 6 (10.2) | 2 (3.4) |
| Total | 58 (98.3) | 24 (40.7) |
ALT, alanine aminotransferase; AST, aspartate amino transferase. *Skin reactions were coded with the use of preferred terms from the Medical Dictionary for Regulatory Activities. These terms include acne pustular, acne, cellulitis, dermatitis acneiform, dry skin, erythema, nail-bed infection, nail-bed inflammation, nail disorder, nail infection, paronychia, pruritus, and rash. Graded according to common toxicity criteria for adverse events version 5.0.