Table 2.
Toxicities in patients receiving any protocol therapy (N=14)
| Grade toxicity | Number of patients with Grade 1 toxicities |
Number of patients with Grade 2 toxicities |
Number of patients with Grade ≥3 toxicities |
|---|---|---|---|
| Injection site erythema | 5 | 0 | |
| Fatigue | 3 | 0 | |
| Flu-like symptoms | 1 | 0 | |
| Pain | 1* | ||
| Myalgias | 1 | 0 | |
| Anorexia | 2 | 0 | |
| Nausea | 2 | 0 | |
| Leukocytosis | 2 | 2 | |
| Neutrophilia | 1 | ||
| Eosinophilia | 1 | 1 | |
| Dyspnea | 1 | ||
| Tachycardia | 1 | ||
| Chest pain | 1 | ||
| Myocardial infarction | 1* |
9 patients received all 6 doses without GM-CSF, 3 patients received GM-CSF with 0,2 and 5 doses of vaccine, 2 patients received 1–2 doses of vaccine without GM-CSF;
1 death from myocardial infarction occurred following GM-CSF and was considered possibly from therapy (the patient did not receive the peptide); this patient also had generalized pain and myalgias after GM-CSF injection