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Anaphylactoid reactions associated with bisantrene infusions
Investigational New Drugs
|January 1, 1983
Summary
Bisantrene administration every three weeks can cause anaphylactoid reactions in some patients. Most reactions occurred after multiple exposures, highlighting a potential life-threatening toxicity risk for ongoing clinical trials.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Bisantrene is an antineoplastic agent used in cancer treatment.
- Adverse drug reactions require careful monitoring in clinical trials.
Purpose of the Study:
- To report the incidence and characteristics of anaphylactoid reactions associated with Bisantrene treatment.
- To alert investigators to a potentially life-threatening toxicity of Bisantrene.
Main Methods:
- Observational analysis of patients receiving Bisantrene on an every three-week schedule.
- Documentation of adverse events, specifically anaphylactoid reactions.
Main Results:
- Nine out of ninety-three patients (9.7%) developed anaphylactoid reactions.
- Reactions were more frequent in patients with multiple Bisantrene exposures.
- Symptoms varied, indicating a range of hypersensitivity responses.
Conclusions:
- Anaphylactoid reactions are a significant toxicity of Bisantrene, occurring in approximately 10% of patients.
- Increased exposure to Bisantrene may heighten the risk of these reactions.
- Awareness of this adverse event is crucial for clinicians and researchers conducting Bisantrene trials.