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- W2281489466 abstract "6070 Background: Nimotuzumab (N) is a humanized MAb to EGFR that has shown evidence of efficacy in patients (pts) with advanced solid tumors, notably without provoking skin rash. Although lack of rash might be a therapeutic advantage, evidence of biological activity of N is needed. To this end, a PD study was performed. Methods: Ten pts with advanced SCCHN, unsuitable for chemo-radiotherapy, were enrolled in a single center phase Ib clinical trial. Pts received 8 weekly infusions of N at 2 dose levels: 200mg and 400mg. The first N infusion was administered 1 week before starting radiation while remaining doses were delivered concomitantly with irradiation. Paired biopsies were taken from skin and primary tumors, before (pre-therapy) and 1 week (on-single agent therapy) after first infusion. A PD study by immunohistochemistry was conducted to assay the effects of N on EGFR—total and phosphorylated (p)—and its signaling pathways ERK and AKT (total and p) as well as proliferation (Ki67). Results: N was well tolerated and there was no evidence of skin rash in any of the treated pts. Objective response was achieved in 80% of pts (2 CR, 6 PR). Median survival time was 7.2 months. PD showed inhibition of p- EGFR in both skin and tumor (Wilcoxon test, p=0.042 skin, p=0.034 tumor). Inhibition of downstream pathways was suggested by a trend in the decrease of p-ERK (p=0.091) and a significant reduction in proliferation (p=0.012). Upregulation of p-AKT was observed in tumor (p=0.043) but not in skin, similarly to what has been reported for other anti-EGFR agents. Characteristic lymphocytic infiltrates, folliculitis or perifolliculitis induced by other EGFR inhibitors were not observed. No associations were found between doses or response and PD effects. Conclusions: These data show that after a short period of exposure, N as a single agent inhibited EGFR phosphorylation and this was accompanied by a trend towards molecular downstream effects consistent with the expected biological effects of EGFR targeting. The absence of inflammatory skin reaction might be linked to the lack of skin toxicity by N. The response rate observed with N and radiation is promising. No significant financial relationships to disclose." @default.
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- W2281489466 date "2008-05-20" @default.
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- W2281489466 title "Pharmacodynamic study of nimotuzumab, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody (MAb), in patients with unresectable squamous cell carcinoma of the head and neck (SCCHN): A SENDO Foundation study" @default.
- W2281489466 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.6070" @default.
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