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The second disease assessment may be done at any time.
Response or progression must be confirmed by a second disease assessment prior to the institution of any new therapy.
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Forty-two patients were evaluable for clinical activity, and 11 patients discontinued treatment before first disease assessment (Table 5).
The primary endpoint of overall response rate was 53% (95% confidence interval [CI] 44 62) and responses were again rapid, with less than 15% of patients demonstrating disease progression at their first disease assessment.
Of the 14 patients who received at least 8 weeks of therapy, stable disease was achieved in five patients at the first disease assessment, with documented disease progression in six patients, and clinical deterioration in keeping with disease progression in the remaining three patients.
However, cetuximab resistance remains common, with 35% of patients progressing at the first disease response assessment (Karapetis et al, 2008).
Additional sampling was performed before dosing, immediately post-dosing and 24 h post-dosing after the second administration, and before dosing and day 17 (day of disease assessment) for the third and sixth administration.
Marked and meaningful improvement was observed in mean change from baseline in VAS scores of patient disease assessment from the first time point after the first dose and was generally maintained throughout the dosing period.
This revised cognitive parameter was named ADAS-1 corresponding to the first subtest of the Alzheimer's disease assessment scale.
If a patient received more than six cycles of mapatumumab therapy, a specimen was collected at the time of disease assessment in every third treatment cycle (i.e., cycles 9, 12, etc).. Blood samples were centrifuged at 1.500 g for 10 min immediately after collection, and plasma was stored frozen at −70°C until assayed.
Scans for disease assessment were performed after the first two cycles.
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