A total of of 14 patients were nonevaluable for response; they either received chemotherapy with concurrent radiotherapy or in the adjuvant setting.
In all, 12 patients were nonevaluable for response in that, although their markers had returned to normal with chemotherapy, there was a residual mass observed at CT scanning that was not amenable to surgical evaluation.
Two patients in Manchester and four patients in Aarhus were nonevaluable for response as they stopped treatment within the first treatment cycle due to toxicity without signs of PD.
Seven patients were nonevaluable for response according to CA125 criteria, five due to less than three samples being available for analysis and two in whom all CA 125 values were <40 U ml−1.
Nine patients were ineligible due to major protocol violations (>1 line of palliative chemotherapy, and past or concurrent history of neoplasm other than colorectal adenocarcinoma in one patient) and 12 patients (not mutually exclusive) were nonevaluable for response.
Assuming that 10% of patients would be nonevaluable and approximately 20% would not be randomised, it was calculated that 105 patients should be enrolled.
Two patients assessed as CR by the investigator (one in each arm) were considered as nonevaluable for response (according to the protocol) by the IDMC because only one or two cycles of chemotherapy were administered.
The median time to disease progression was 15.1 months for patients with either a complete or partial response, 5.9 months for patients with stable disease, and 1.9 months for patients who had disease progression as the best response or who were nonevaluable.
Two of the screened patients were screening failures and 33 were nonevaluable as a result of insufficient data available for the study.
There was no therapeutic effect in other solid tumours treated, although three out of six patients were nonevaluable due to withdrawal or disease progression.
