Table 2.
WAI Regimen (n = 98)† |
CIM Regimen (n = 99)† |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Grade | Grade | |||||||||
Adverse Event | 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 |
Anemia | 88 | 5 | 4 | 1 | 0 | 41 | 12 | 35 | 10 | 1 |
Gastrointestinal | 33 | 33 | 21 | 8 | 3 | 37 | 33 | 19 | 8 | 2 |
Genitourinary | 82 | 13 | 3 | 0 | 0 | 77 | 12 | 10 | 0 | 0 |
Renal | 98 | 0 | 0 | 0 | 0 | 97 | 1 | 1 | 0 | 0 |
Hepatic | 94 | 2 | 0 | 1 | 1 | 94 | 4 | 1 | 0 | 0 |
Fever | 97 | 1 | 0 | 0 | 0 | 87 | 3 | 9 | 0 | 0 |
Infection | 97 | 0 | 0 | 1 | 0 | 98 | 0 | 0 | 0 | 1* |
Fatigue | 92 | 5 | 0 | 1 | 0 | 77 | 13 | 6 | 2 | 1 |
Alopecia | 98 | 0 | 0 | 0 | 0 | 54 | 12 | 33 | 0 | 0 |
Peripheral Neuropathy | 97 | 1 | 0 | 0 | 0 | 87 | 6 | 4 | 2 | 0 |
Central Neuropathy | 96 | 2 | 0 | 0 | 0 | 79 | 9 | 4 | 7 | 0 |
Allergy | 98 | 0 | 0 | 0 | 0 | 95 | 2 | 2 | 0 | 0 |
Cutaneous | 89 | 4 | 5 | 0 | 0 | 96 | 3 | 0 | 0 | 0 |
Cardiovascular | 97 | 0 | 0 | 0 | 1 | 92 | 2 | 1 | 2 | 2 |
Pulmonary | 97 | 0 | 1 | 0 | 0 | 93 | 3 | 3 | 0 | 0 |
Pain | 94 | 2 | 2 | 0 | 0 | 86 | 9 | 3 | 1 | 0 |
Metabolic | 97 | 1 | 0 | 0 | 0 | 90 | 2 | 2 | 3 | 2 |
Abbreviations: WAI, whole abdominal irradiation; CIM, cisplatin, ifosfamide with mesna chemotherapy.
Adverse events summarized for those who initiated study treatment.
One patient died of a systemic infection complicated by neutropenia which was attributed to CIM treatment.