Phase II study of erlotinib (OSI-774) in patients with metastatic colorectal cancer

摘要: Erlotinib (Tarceva™, OSI-774), a potent epidermal growth factor receptor tyrosine kinase inhibitor (EGFR), was evaluated in phase II study to assess its activity patients with metastatic colorectal cancer. In all, 38 cancer were treated erlotinib at continuous daily oral dose of 150 mg. Radiological evaluation carried out every 8 weeks and tumour biopsies performed before treatment on day 8. Of 31 evaluable patients, 19 (61%) had progressive disease 12 (39%) stable (s.d.). The median time progression for those having s.d. 123 days (range 108–329 days). most common adverse events rash 34 diarrhoea 23 patients. Correlative studies conducted investigate the effect downstream signalling. Tumour tissue correlations based usable from eight match paired samples pre- therapy, showed statistically significant decrease intensity both pEGFR (P=0.008) phospho-extracellular signal-regulated (ERK) week after commencement treatment. No other change markers observed. well tolerated toxicities being diarrhoea. More than one-third minimum weeks. reduction phosphorylated EGFR ERK post-treatment.