Baseline documentation of Target and Non Target lesions

♦ All measurable lesions up to a maximum of five lesions per organ and ten lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.

♦ Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).

♦ A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumour response.

♦ All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.

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