Side effects after treatment with FCM and R-FCM
. | FCM . | . | R-FCM . | . | ||
|---|---|---|---|---|---|---|
| Side effect . | Grades 1 + 2, % . | Grades 3 + 4, % . | Grades 1 + 2, % . | Grades 3 + 4, % . | ||
| Allergy | 0.8 | 0.0 | 3.5 | 0.3 | ||
| Chill | 0.5 | 0.0 | 5.7 | 0.0 | ||
| Exantheme | 3.5 | 0.0 | 2.8 | 0.0 | ||
| Headache | 2.2 | 0.0 | 5.3 | 0.3 | ||
| Granulocytes | 14.3 | 40.6 | 18.7 | 39.6 | ||
| Hemoglobin | 44.4 | 5.3 | 44.7 | 5.9 | ||
| Lymphocytes | 3.9 | 39.4 | 10.3 | 51.2 | ||
| Thrombocytes | 33.3 | 11.3 | 30.8 | 11.7 | ||
| Leukocytes | 16.9 | 55.6 | 23.5 | 53.6 | ||
| Infection | 6.6 | 1.8 | 6.3 | 1.4 | ||
| Fever | 2.3 | 0.5 | 1.1 | 1.1 | ||
| Neusea/vomiting | 22.1 | 0.0 | 17.8 | 1.1 | ||
| Mucositis | 3.4 | 0.0 | 4.5 | 0.3 | ||
| Diarrhea | 0.5 | 0.5 | 3.9 | 0.6 | ||
| Cardiac dysfunction | 0.0 | 0.9 | 0.3 | 0.0 | ||
| Neurotoxicity | 1.1 | 0.1 | 0.8 | 0.2 | ||
| Liver | 3.1 | 0.0 | 5.2 | 0.0 | ||
| Lactate dehydrogenase | 6.2 | 0.0 | 6.3 | 0.3 | ||
| Alopecia | 10.7 | 7.1 | 10.5 | 3.7 | ||
. | FCM . | . | R-FCM . | . | ||
|---|---|---|---|---|---|---|
| Side effect . | Grades 1 + 2, % . | Grades 3 + 4, % . | Grades 1 + 2, % . | Grades 3 + 4, % . | ||
| Allergy | 0.8 | 0.0 | 3.5 | 0.3 | ||
| Chill | 0.5 | 0.0 | 5.7 | 0.0 | ||
| Exantheme | 3.5 | 0.0 | 2.8 | 0.0 | ||
| Headache | 2.2 | 0.0 | 5.3 | 0.3 | ||
| Granulocytes | 14.3 | 40.6 | 18.7 | 39.6 | ||
| Hemoglobin | 44.4 | 5.3 | 44.7 | 5.9 | ||
| Lymphocytes | 3.9 | 39.4 | 10.3 | 51.2 | ||
| Thrombocytes | 33.3 | 11.3 | 30.8 | 11.7 | ||
| Leukocytes | 16.9 | 55.6 | 23.5 | 53.6 | ||
| Infection | 6.6 | 1.8 | 6.3 | 1.4 | ||
| Fever | 2.3 | 0.5 | 1.1 | 1.1 | ||
| Neusea/vomiting | 22.1 | 0.0 | 17.8 | 1.1 | ||
| Mucositis | 3.4 | 0.0 | 4.5 | 0.3 | ||
| Diarrhea | 0.5 | 0.5 | 3.9 | 0.6 | ||
| Cardiac dysfunction | 0.0 | 0.9 | 0.3 | 0.0 | ||
| Neurotoxicity | 1.1 | 0.1 | 0.8 | 0.2 | ||
| Liver | 3.1 | 0.0 | 5.2 | 0.0 | ||
| Lactate dehydrogenase | 6.2 | 0.0 | 6.3 | 0.3 | ||
| Alopecia | 10.7 | 7.1 | 10.5 | 3.7 | ||
Side effects were comparable between both treatment arms with the exception of a higher frequency of lymphocytopenia after treatment with R-FCM (P = .006). The difference was clinically irrelevant, however, because no increase in infectious complications was observed.