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Nine patients (18 %) achieved an at best response of partial response (PR), 6 (12%%) of which had responses confirmed 4 weeks after their initial responses were observed.
These data indicated that improvement in PFS was not derived solely from the subset of patients with a best response of partial response.
However, the percentage of patients with a week 4 Cτ above 20.5 μg ml−1 who had a best response of partial or complete response was more than double that of patients with a week 4 Cτ ⩽20.5 μg ml−1 (45 and 19%, respectively).
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EQ-5D individual domains, disease control (defined as best response of complete response, partial response or stable disease as evaluated by physician), body weight, concomitant medications and toxicities were analyzed by descriptive statistics.
The overall disease control rate, with disease control defined as physician-evaluated best response of complete or partial response or stable disease, was 60.3% (314 patients; 95% CI 55.9%; 64.5%).
To assess whether the treatment differences in PFS were due to patients with an objective response, a post-hoc sensitivity analysis of PFS that removed responding patients in the panitumumab group (i.e., patients with a best response of at least partial response) was conducted to evaluate the contribution of non-responding patients on the treatment effect with panitumumab.
The disease control rate (DCR) was defined as the percentage of patients with a best response of a complete or partial response, or stable disease.
Eleven patients had a best response of stable disease and one patient achieved partial response.
No patients had a partial or complete response to therapy, and only two patients had a best response of stable disease.
ASA404 produced two unconfirmed partial responses at 1100 and 1300 mg m−2, and 28 patients had a best response of stable disease.
Of four patients with best tumour response of partial response, all four patients had received PR-104 at dose-levels of 770 mg/m or higher; two had partial responses confirmed on a subsequent scan (one each with nasopharyngeal carcinoma and non-small cell lung cancer), two had unconfirmed partial responses (one each with squamous cell of the tongue and nasopharyngeal carcinoma).
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