Docetaxel plus cetuximab as second-line treatment for docetaxel-refractory oesophagogastric cancer: The AGITG ATTAX2 trial.

Abstract

Background:Cetuximab can reverse chemotherapy resistance in colorectal cancer. This study evaluated the efficacy and safety of the combination of docetaxel and cetuximab as a second-line treatment in docetaxel-refractory oesophagogastric cancer. Method(s):Patients received docetaxel 30 mg m-2 on days 1 and 8, every 3 weeks and cetuximab 400 mg m-2 on day 1, then 250 mg m-2 weekly. Biomarker mutation analysis was performed. Result(s):A total of 38 patients were enrolled. Response rates were PR 6% (95% CI 2-19%), s.d. 43% (95% CI 28-59%). Main grade 3/4 toxicities were febrile neutropenia, anorexia, nausea, diarrhoea, stomatitis, and acneiform rash. Median progression-free and overall survival were 2.1 and 5.4 months, respectively. A landmark analysis showed a trend to improved survival times with increased grade of acneiform rash. No KRAS, BRAF or PIK3CA mutations were observed. Conclusion(s):Cetuximab and docetaxel achieve modest responses rates, but maintain comparable survival times to other salvage regimens with low rates of toxicity. © 2013 Cancer Research UK.