EXTREME study: Most common adverse reactions1
- EXTREME trial: Observed toxicities were consistent with individual agent safety profiles2
- For cardiac disorders, approximately 9% of patients in both treatment arms in EXTREME experienced a cardiac event. The majority of these events occurred in patients who received cisplatin and fluorouracil, with or without cetuximab. Cardiac disorders were as follows: 11% and 12% of patients who received cisplatin and fluorouracil, with or without cetuximab, respectively, and 6% or 4% in patients who received carboplatin and fluorouracil, with or without cetuximab, respectively. In both arms, the incidence of cardiovascular events was higher in the cisplatin and fluorouracil containing subgroup. Death attributed to cardiovascular events or sudden death was reported in 3% of the patients in the cetuximab with platinum-based therapy and fluorouracil arm and in 2% of the patients in the platinum-based therapy and fluorouracil-alone arm
- Because ERBITUX provides approximately 22% higher exposure relative to the cetuximab product used in the study, the data provided may underestimate the incidence and severity of adverse reactions anticipated with ERBITUX for this indication; however, the tolerability of the recommended dose is supported by safety data from additional studies of ERBITUX
¶Adverse reactions occurring in ≥10% of patients in the cetuximab combination arm and at a higher incidence (≥5%) compared to the platinum-based therapy and fluorouracil-alone arm.
#Adverse reactions were graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0.
**Infusion reaction defined as “anaphylactic reaction,” “hypersensitivity,” “fever and/or chills,” “dyspnea,” or “pyrexia” on the first day of dosing.
††Infection excludes sepsis-related reactions which are presented separately.
‡‡Acneiform rash defined as “acne,” “dermatitis acneiform,” “dry skin,” “exfoliative rash,” “rash,” “rash erythematous,” “rash macular,” “rash papular,” or “rash pustular.”