Incidence of hypertension and clinical correlates
hypertension, proteinuria
HYPERTENSION
Table Incidence of each grade of hypertension in each treatment arm over the first 12 weeks of treatment.Clinical characteristics of patients with and without treatment‐related hypertension, in each treatment arm.
Statistically significant difference in proteinuria levels between patients in cetuximab+placebo arm who developed hypertension compared to those that did not (Pre‐existing hypertension was apparent in one patient (0.3%) in the cetuximab+brivanib arm; their grade remained stable throughout treatment. There were five patients (1.3%) in the cetuximab only arm who demonstrated pre‐existing hypertension; in two patients with Grade 1 hypertension, their condition became worse (becoming Grade 2) during treatment. Incidence and severity of hypertension during treatment is summarized for each treatment arm in Table Sodium, potassium, calcium, and magnesium levels did not differ as a function of hypertension or treatment group. Creatinine levels in all patients was seen to decrease shortly after treatment was initiated. In patients with brivanib‐associated Grade 2 or 3 hypertension, creatinine levels significantly increased by 12 weeks (Figure (A) Time‐related changes in serum creatinine levels in patients who received cetusimab + placebo, and in the brivanib + cetuximab arm who did and did not have treatment‐related hypertension. (B) Stacked bar graph comparing response categories in brivanib group. (C) Kaplan–Meier curve comparing progression‐free survival (PFS) in patients treated with brivanib + cetuximab (as a function of treatment‐related hypertension) and cetuximab + placebo controls. (D) OS as a function of treatment‐related hypertension in the brivanib + cetuximab arm, as well as controls.In the brivanib‐treated arm, response rate based on RECIST 1.0