Table 3.
Select Adverse Events Possibly, Probably, or Definitely Attributed to Bevacizumab Over 202 Cycles in 19 Patients
| Toxicity | Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
||||
|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | |
| Proteinuria | ||||||||
| Events | 32 | 16 | 12 | 6 | ||||
| Patients | 12 | 63 | 3 | 16 | ||||
| Hypertension* | ||||||||
| Events | 12 | 6 | 7 | 3 | ||||
| Patients | 1 | 5 | 6 | 32 | ||||
| LV dysfunction | ||||||||
| Events | 1 | < 1 | ||||||
| Patients | 1 | 5 | ||||||
| Thrombosis† | ||||||||
| Events | 1 | < 1 | ||||||
| Patients | 1 | 5 | ||||||
| Neutropenia‡ | ||||||||
| Events | 3 | 1 | 8 | 2 | 5 | 1 | ||
| Patients | 3 | 16 | 2 | 11 | ||||
| Anemia | ||||||||
| Events | 1 | < 1 | ||||||
| Patients | 1 | 5 | ||||||
| Thrombocytopenia | ||||||||
| Events | 10 | 5 | ||||||
| Patients | 5 | 26 | ||||||
| Epistaxis | ||||||||
| Events | 11 | 5 | ||||||
| Patients | 8 | 42 | ||||||
| Infection§ | ||||||||
| Events | 4 | 2 | 5 | 2 | 2 | 1 | 1 | < 1 |
| Patients | 2 | 11 | 2 | 11 | 2 | 11 | 1 | 5 |
| Headache | ||||||||
| Events | 12 | 6 | 3 | 1 | 2 | 1 | ||
| Patients | 3 | 16 | 3 | 16 | 2 | 11 | ||
| Vomit | ||||||||
| Events | 1 | < 1 | 1 | < 1 | ||||
| Patients | 1 | 5 | 1 | 5 | ||||
NOTE. All 19 patients are included in the toxicity evaluation. The median number of cycles is nine (range, one to 37 cycles). Number of events includes adverse events over 202 cycles. Number of patients includes worst grade for each adverse event per patient over 19 patients.
Abbreviation: LV, left ventricular.
Grade 3 hypertension was defined as addition of antihypertensive agent, with management of hypertension based on protocol guidelines. Five patients initiated antihypertensive therapy, and two of these patients needed a second antihypertensive agent added later in the protocol.
Basilic vein intravenous line–associated thrombosis managed by pulling line.
Four of five instances of grade 3 neutropenia occurred in a patient with benign ethnic neutropenia43 whose baseline absolute neutrophil count would be categorized by Common Terminology Criteria for Adverse Events 0 as a grade 2 adverse event (absolute neutrophil count, 1,000 to 1,500 cells/μL).
Infections included soft tissue infection (n = 5), gingival infections (n = 4), mild upper respiratory tract infections (n = 2), or oral herpes (n = 1). Soft tissue infections were related to underlying Kaposi's sarcoma or poor dentition.