Figure 1.
Consort diagram describing the main characteristics of the present clinical study.
Table 1.
Selected patient characteristics.
Table 2.
Selected tumor characteristics.
Table 3.
Treatment Characteristics.
Figure 2.
Waterfall plot of best change in target-lesion size from baseline, assessed by central review.
In four patients (marked with a star), the best change in total lesion size from baseline showed an overall decrease but they were characterized as having progressive disease (PD) due to the development of new lesions. In four other patients (marked with a star as well), the best change in total lesion size from baseline was 100% but they were identified as partial response (PR) since in non-target lesions the response was stable disease (SD). CR: complete response.
Table 4.
Best response as given by local investigators (n = 59).
Table 5.
Number of patients with severe adverse events.
Figure 3.
PFS and survival for Groups A and B (red lines: PFS; blue lines: survival).
Table 6.
Categorical (SNP and IHC) marker associations with mRNA RQ values (continuous variables).
Table 7.
Associations between SNP and IHC markers.
Table 8.
Biomarker associations with patient survival (log-rank test).
Table 9.
Biomarker associations with patient progression-free survival (log-rank test).
Figure 4.
Predictive specificity of TUBB3 mRNA expression for survival in treatment Groups A (40 mg/m2, 3-weekly) and B (20 mg/m2, weekly).
TUBB3 RQ value cut-off was set at 75%. Among patients in Group B, those with tumors expressing high TUBB3 transcript levels had significantly shorter survival.