For patients with measurable disease at entry (at least one lesion that has a shortest diameter

≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:

1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.
2. The patient has died from any cause.
3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

Number of months from randomisation to the date of death from any cause

An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.

An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan.

Patients are only included in the analysis if they have measurable disease at baseline based on central.

Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.

The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.

Number of days known not to have used any steroids prior to progression