Figure 2. Differential impact of sunitinib plus paclitaxel chemotherapy when treating established primary tumors versus postsurgical advanced metastatic disease.

Two independent metastatic therapy experiments are shown in Fig. 2A and 2B. Paclitaxel alone administered ip at an MTD of 30mg/kg once every 2 weeks shows extensions of median survival in Fig. 2A and Fig. 2B which was not statistically significant in one case (Fig. 2A). Combination of sunitinib with paclitaxel does not improve the survival advantages over paclitaxel alone (Fig. 2B) and may even worsen outcome (Fig. 2A). In the advanced metastasis studies, median survival for 1) control vehicle treatment was 54 – 65 days, 2) paclitaxel treatment was 61 – 88.5 days, 3) sunitinib treatment was 65 – 66 days, and 4) sunitinib plus paclitaxel was 50 – 76 days; p values were not significant for Fig. 2A; Fig. 2B *paclitaxel vs control p=0.03; # sunitinib + paclitaxel vs control p=0.003. In established primary tumors, MTD paclitaxel alone shows no activity whereas sunitinib alone or in combination with MTD paclitaxel inhibited tumor growth (Fig. 2C). In the advanced metastasis study (Fig. 2B), primary tumors were surgically resected 20 days after injection of 2x10⁶ cells when average size was approximately 400mm³ and treatment was initiated 20 days later; in the primary tumor study (Fig. 2C) treatment was initiated 14 days after cell injection when average tumor size was 150mm³.