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In the cancer patients, the pre-treatment median serum levels of CD44st, CD44v5 and CD44v6 were 327 +/- 134, 312 +/- 118 and 211 +/ 110 ng/ml, respectively. The corresponding post-treatment levels were 185 +/- 103, 177 +/- 90 and 110 +/- 65 ng/ml. In the healthy volunteers, the median serum levels of CD44st, CD44v5 and CD44v6 were 133 +/- 40, 142 +/- 39 and 86 +/- 22 ng/ml, respectively. In the cancer patients, there was no significant correlation between the serum levels of CD44st, CD44v5 and CD44v6 and the clinicopathological variables. The pre-treatment serum levels of CD44st, CD44v5 and CD44v6 were closely associated with TNM stage (p = 0.0017, 0.0005 and 0.0046, respectively). The median pre-treatment serum levels of CD44st, CD44v5 and CD44v6 were significantly higher than those in the control group (p = 0.0002, 0.0065 and 0.0038, respectively). The median post- treatment serum levels of CD44st, CD44v5 and CD44v6 were significantly lower than the pre-treatment levels (p = 0.0003, 0.0027 and 0.0034, respectively).

The anti-tumour effect of the angiogenic inhibitor TNP470, sigma-(chloro-acetyl-carbamoyl) fumagillol, a synthetic analogue of fumagillin, was studied in vitro and in vivo using KB cells, one of the human head and neck carcinoma cell lines that produce interleukin(IL)-8. In the in vitro study, the combination treatment of TNP470 and anti-IL-8 antibody significantly reduced the proliferation of KB cells. In the in vivo studies, TNP470 administration by any route (intratumoral: i.t., intraperitoneal: i.p., intravenous: i.v.) reduced the tumour volume significantly, compared to the control group. Among the groups administered TNP470, the anti-tumour effect was strongest in the it group. Furthermore, the concurrent treatment of anti-IL-8 antibody and TNP470 also maximally reduced the tumour volume. The combination therapy of TNP470 and anti-IL-8 antibody was very effective. These results suggest that combination therapy of TNP470 and anti-IL-8 antibody could be beneficial for solid tumours, such as head and neck cancer.

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