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These grades of reactions do not usually lead to treatment interruptions.
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The grades of ocular reaction were recorded at 1, 24, 48 and 72 hours after treatment.
Patients who achieved a CR or PR as best response showed in 90.8% of the cases any grade of skin reaction, compared with only 76.2% who did not respond (sum of the pts with stable disease or progressive disease) (P<0.0001, χ-test).
The dose of the irinotecan did not correlate with the grade of the reaction or the size of the depot on CT imaging.
Figure 2 shows the number of patients with a volume receiving more than V > 107% by grade of skin reaction: hot spots are more represented among G2 – G3 patients.
A slight to moderate grade of inflammatory reaction was observed in the area surrounding the implant particles and was accompanied by the presence of a vascularized fibroconnective inflammatory tissue, macrophages and multinucleated giant cells.
Patients with on-trial HSR were further subdivided based on the grade of their reaction, which still showed a statistically significantly higher proportion of patients with HSR of any grade having a BRCA mutation compared with those without a reaction (P=0.027).
A correlation was found between the amount of wear and the grade of histiocytic reaction (p = 0.02), but there were no statistically significant effects (Fisher's exact test) induced by the presence of tissue wear particles and histocytic reaction on the osteolysis process (p = 0.2 and p = 0.3, respectively).
Symptom intensity of redness, swelling and fever was graded by millimeter of reaction and degrees Celsius of fever, respectively, and all other symptoms were graded by the subject using a pre-defined scale.
The severity of reactions was usually mild to moderate (grade 1 or 2); grade 3 to 4 reactions were rare and dose-dependent.
Actuarial incidence of grade 2 4 reactions was analysed in relation to clinical, anatomical and dosimetric/geometric variables using univariate and multivariate analyses.
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