Table 4.
Toxicity by WHO Criteria in Cancer Trials With LND
| WHO Toxicity Grades (%)* |
||||||
|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | P | |
| Nausea/vomiting | NS | |||||
| EPI | 16 | 24 | 43 | 17 | 0 | |
| EPI + LND | 19 | 21 | 46 | 14 | 0 | |
| Stomatitis | NS | |||||
| EPI | 65 | 18 | 10 | 7 | 0 | |
| EPI + LND | 67 | 18 | 13 | 1 | 1 | |
| Diarrhea | NS | |||||
| EPI | 90 | 3 | 6 | 1 | 0 | |
| EPI + LND | 92 | 2 | 5 | 1 | 0 | |
| Liver | NS | |||||
| EPI | 97 | 1 | 2 | 0 | 0 | |
| EPI + LND | 96 | 2 | 0 | 2 | 0 | |
| Neurotoxicity | NS | |||||
| EPI | 99 | 0 | 0 | 1 | 0 | |
| EPI + LND | 99 | 1 | 0 | 0 | 0 | |
| Fever | NS | |||||
| EPI | 86 | 6 | 8 | 0 | 0 | |
| EPI + LND | 81 | 5 | 11 | 2 | 1 | |
| Cardiac | NS | |||||
| EPI | 97 | 3 | 0 | 0 | 0 | |
| EPI + LND | 98 | 2 | 0 | 0 | 0 | |
| Alopecia | NS | |||||
| EPI | 6 | 5 | 31 | 58 | 0 | |
| EPI + LND | 9 | 4 | 32 | 53 | 2 | |
| Myalgia | <.001 | |||||
| EPI | 86 | 10 | 4 | 0 | 0 | |
| EPI + LND | 58 | 19 | 13 | 8 | 2 | |
| Asthenia | NS | |||||
| EPI | 55 | 25 | 15 | 4 | 1 | |
| EPI + LND | 53 | 24 | 17 | 6 | 0 | |
| WBC | NS | |||||
| EPI | 55 | 25 | 15 | 4 | 1 | |
| EPI + LND | 54 | 23 | 16 | 7 | 0 | |
| Nadir WBC† | NS | |||||
| EPI | 3 | 9 | 33 | 49 | 6 | |
| EPI + LND | 13 | 13 | 24 | 35 | 15 | |
| Platelets | NS | |||||
| EPI | 100 | 0 | 0 | 0 | 0 | |
| EPI + LND | 97 | 1 | 2 | 0 | 0 | |
| Nadir Platelets† | NS | |||||
| EPI | 76 | 12 | 8 | 4 | 0 | |
| EPI + LND | 74 | 11 | 7 | 8 | 0 | |
| Hemoglobin | NS | |||||
| EPI | 43 | 40 | 13 | 4 | 0 | |
| EPI + LND | 42 | 40 | 14 | 4 | 0 | |
*
For each patient, the most severe instance of toxicity is taken into account.
†
Hematologic toxicity at nadir was recorded in 67 EPI patients and in 62 EPI + LND patients. WHO, World Health Organization; NS, not significant; EPI, epirubicin; LND, lonidamine; WBC, white blood cell count. Adapted with permission from Dogliotti et al26