Tumor assessment criteria in this study were adapted from the WHO criteria for use with MRI scans in brain cancer and incorporated corticosteroid dose and clinical deterioration attributable to progressive tumor burden (Macdonald et al.1990):
• Index lesions are contrast-enhancing lesions with clear borders that are ≥ 10 mm at baseline. These lesions were measured bi-dimensionally at each scan using the outer diameter of the contrast-enhancing component, and the sum of the product of diameters (SPD) of index lesions was calculated at each visit.
• Non-index lesions are enhancing lesions that are small or with unclear borders, as well as non-contrast-enhancing lesions (such as hyper-intensity on FLAIR sequences) or leptomeningeal disease.
• A complete response required disappearance of all index and non-index lesions; in addition, the patient could not be taking corticosteroids above the physiologic level (i.e., equivalent of 20 mg of hydrocortisone per day) and could have no observed clinical deterioration by investigator assessment.
• A partial response required a ≥ 50% decrease in the SPD of index lesions; in addition, the corticosteroid dose at the time of the MRI scan could be no greater than the maximum dose used in the first 6 weeks after initiation of therapy. The patient could have no observed clinical deterioration by investigator assessment.
• Both complete and partial responses had to be confirmed at a second scan at least 4 weeks later.
• Progressive disease was defined by any of the following: appearance of a new lesion, ≥ 25% increase in the SPD of index lesions compared with the nadir, unequivocal progression of non-index lesions, including non-contrast-enhancing lesions, or clear clinical deterioration by investigator assessment in the absence of radiologic worsening.
................................................. Notice requirement for confirmation of Complete Response and Partial Response, but not progressive disease.
Also notice, this trial used Macdonald + FLAIR. Just like the DCVax P3 trial uses.
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