Table 3.
Adverse events
| Adverse Event | PLD N = 98 | Capecitabine N = 102 | P a | ||
|---|---|---|---|---|---|
| All grades No. (%) | Grade 3–4 No. (%) | All grades No. (%) | Grade 3–4 No. (%) | ||
| Hematologic Toxicity | |||||
| Leukopenia | 37 (38) | 4 (4) | 17 (17) | 1 (1) | .002 |
| Anemia | 25 (26) | 1 (1) | 21 (20) | 5 (5) | .10 |
| Neutropenia | 18 (18) | 3 (3) | 10 (10) | 2 (2) | .19 |
| Thrombocytopenia | 6 (6) | 1 (1) | 6 (6) | 1 (1) | 1.0 |
| Non-hematologic toxicity occurring in ≥20 % of patients in either arm | |||||
| Hand-foot syndrome | 65 (66) | 38 (39) | 69 (67) | 27 (26) | .08 |
| Stomatitis | 39 (40) | 6 (6) | 18 (17) | 0 | .0007 |
| Fatigue | 53 (54) | 4 (4) | 55 (54) | 7 (7) | .71 |
| Ear, nose, throat abnormality | 42 (43) | 6 (6) | 17 (17) | 0 | <.0001 |
| Nausea | 41 (42) | 0 | 42 (41) | 2 (2) | .59 |
| Alopecia | 27 (28) | – | 10 (10) | – | .002 |
| Constipation | 25 (26) | 0 | 10 (10) | 0 | .005 |
| Vomiting | 18 (18) | 0 | 30 (30) | 2 (2) | .09 |
| Peripheral sensory neuropathy | 17 (17) | 1 (1) | 25 (24) | 0 | .19 |
| Diarrhea | 16 (16) | 0 | 44 (43) | 13 (13) | <.0001 |
| Dyspnea | 14 (14) | 3 (3) | 24 (24) | 7 (7) | .23 |
| Cardiac events | |||||
| Total events | 9 (9) | 1 (1) | 13 (13) | 0 | .50 |
| Without anthracycline pretreatment | |||||
| Total no. of patients | 61 | 64 | |||
| Patients with cardiac events, no. (%) | 6 (10) | 1 (2) | 6 (9) | 0 (0) | 1.0b |
| With anthracycline pretreatment | |||||
| Total no. of patients | 37 | 38 | |||
| Patients with cardiac events, no. (%) | 3 (8) | 0 | 7 (18) | 0 | 0.31b |
a Fisher’s exact test for grade 0 versus 1–2 versus 3–5
b Fisher’s exact test