TABLE 3.
Adverse Events in the Capecitabine, XELOX, and PF Arms During the Total Therapy
| Characteristic | Any Grade | Grade ≥3 | ||||
|---|---|---|---|---|---|---|
| Capecitabine (n = 80), No. (%) | XELOX (n = 85), No. (%) | PF (n = 81), No. (%) | Capecitabine (n = 80), No. (%) | XELOX (n = 85), No. (%) | PF (n = 81), No. (%) | |
| Any | 74 (92.5) | 85 (100) | 81 (100) | 23 (28.8) | 31 (36.5) | 37 (45.7) |
| GI | ||||||
| Nausea | 63 (78.8) | 72 (84.7) | 73 (90.1) | 3 (3.8) | 1 (1.2) | 4 (4.9) |
| Abdominal distension | 12 (15) | 22 (25.9) | 27 (33.3) | 1 (1.3) | 0 | 0 |
| Anorexia | 7 (8.8) | 13 (15.3) | 14 (17.3) | 0 | 1 (1.2) | 2 (2.5) |
| Diarrhea | 3 (3.8) | 6 (7.1) | 6 (7.4) | 0 | 1 (1.2) | 0 |
| Hematologic | ||||||
| Leukopenia | 44 (55) | 61 (71.8) | 64 (79) | 2 (2.5) | 6 (7.1) | 17 (21) |
| Anemia | 11 (13.8) | 12 (14.1) | 21 (25.9) | 0 | 1 (1.2) | 2 (2.5) |
| Thrombocytopenia | 9 (11.3) | 16 (18.8) | 19 (23.5) | 2 (2.5) | 4 (4.7) | 6 (7.4) |
| Bone marrow inhibition | 0 | 0 | 3 (3.7) | 0 | 0 | 2 (2.5) |
| Radiation induced | ||||||
| Esophageal pain | 36 (45) | 40 (47.1) | 27 (33.3) | 6 (7.5) | 2 (2.4) | 4 (4.9) |
| Esophagitis | 32 (40) | 26 (30.6) | 35 (43.2) | 2 (2.5) | 1 (1.2) | 1 (1.2) |
| Pneumonitis | 8 (10) | 4 (4.7) | 5 (6.2) | 6 (7.5) | 3 (3.5) | 5 (6.2) |
| Dermatitis | 1 (1.3) | 0 | 2 (2.5) | 0 | 0 | 1 (1.2) |
| Esophagotracheal fistula | 1 (1.3) | 3 (3.5) | 0 | 1 (1.3) | 3 (3.5) | 0 |
| Neurologic | ||||||
| Peripheral neuropathy | 6 (7.5) | 43 (50.6) | 35 (43.2) | 0 | 3 (3.5) | 1 (1.2) |
| Constitutional symptoms | ||||||
| Pneumonitis | 19 (23.8) | 26 (30.6) | 17 (21) | 12 (15) | 11 (12.9) | 12 (14.8) |
| Fever | 10 (12.5) | 13 (15.3) | 10 (12.3) | 0 | 1 (1.2) | 0 |
| Fatigue | 6 (7.5) | 5 (5.9) | 3 (3.7) | 0 | 0 | 0 |
| Skin and mucosa | ||||||
| Hand-foot syndrome | 20 (25) | 22 (25.9) | 4 (4.9) | 0 | 1 (1.2) | 0 |
| Mucositis | 7 (8.8) | 11 (12.9) | 26 (32.1) | 1 (1.3) | 2 (2.4) | 7 (8.6) |
Abbreviations: PF regimen, fluorouracil plus cisplatin; XELOX regimen, capecitabine plus oxaliplatin.