Comment: Overall the two arms were reasonably balanced – the control arm had more patients with the poorer outlook due to having more liver metastases, and fewer with the better prognosis associated with de novo presentation but had more patients with a better ECOG PS 0.
Table 16 in the CSR includes data about the recurrence type. This includes ‘newly diagnosed’ as a significant category (17.7% of total population) amongst breakdown by anatomical site which makes it difficult to establish how many in the each arm of the study had locoregional disease only. The sponsor is requested to provide this information as this is a population identified in the indication. (Clinical Question)
Table 13: Study A5481023 Summary of demographic and baseline characteristics by treatment (ITT population).
Prior treatments presented in the Table 14 and in more detail in Table 15.