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%).
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.
A second patient with oesophageal cancer completed 21 cycles of the antibody (including 10 with the combination) with a best response of SD, and complete resolution of tumour-associated dysphagia.
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).
The secondary endpoints are the following: Disease Control Rate (DCR), Disease Control Rate is defined as the proportion of patients who have a best response rating of complete response (CR), partial response (PR) or stable disease (SD) according to RECIST guidelines 1.1 that is achieved during treatment or within 30 days after termination of study medication.
Toxicity Toxicity will be evaluated according to NCI-CTC AE V4.0 Disease Control Rate (DCR), Disease Control Rate is defined as the proportion of patients who have a best response rating of complete response (CR), partial response (PR) or stable disease (SD) according to RECIST guidelines 1.1 that is achieved during treatment or within 30 days after termination of study medication.
Disease control was defined as the best response out of complete response, partial response, or stable disease, which was confirmed and sustained for 4 weeks or longer.
Overall tophus CR was the proportion of patients achieving a best response of CR (without any new/enlarging tophi) and target tophus complete response (TT-CR) was the proportion of all tophi with CR.
No patients had a partial or complete response to therapy, and only two patients had a best response of stable disease.
Efficacy end points included best overall clinical response, PFS, ORR, disease control rate and prolonged disease control (PDC, defined as a best overall response of complete response, partial response or stable disease of at least 120 days) rate, duration of response and duration of disease control.
