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ᅟ  The overall purpose of this study is to provide proof of concept for introducing the anthracycline epirubicin as an effective, biomarker-guided treatment for metastatic colorectal cancer (mCRC) patients who are refractory to treatment with oxaliplatin-based chemotherapy and have  TOP2A  gene amplification in their tumor cells.    Background  Epirubicin is an anthracycline that targets DNA topoisomerase 2-α enzyme encoded by the  TOP2A  gene. It is used for treatment of several malignancies, but currently not in CRC.  TOP2A  gene amplifications predict improved efficacy of epirubicin in patients with breast cancer and thus could be an alternative option for patients with CRC and amplified  TOP2A  gene. We have previously analysed the frequency of  TOP2A  gene aberrations in CRC and found that 46.6 % of these tumors had  TOP2A  copy gain and 2.0 % had loss of  TOP2A  when compared to adjacent normal tissue. The  TOP2A  gene is located on chromosome 17 and when the  TOP2A /CEN-17 ratio was applied to identify tumors with gene loss or amplifications, 10.5 % had a ratio ≥ 1.5 consistent with gene amplification and 2.6 % had a ratio ≤ 0.8 suggesting gene deletions. Based on these observations and the knowledge gained from treatment of breast cancer patients, we have initiated a prospective clinical, phase II protocol using epirubicin (90 mg/m2 iv q 3 weeks) in mCRC patients, who are refractory to treatment with oxaliplatin.    Methods/Design  The study is an open label, single arm, phase II study, investigating the efficacy of epirubicin in patients with oxaliplatin refractory mCRC and with a cancer cell  TOP2A /CEN-17 ratio ≥ 1.5.  TOP2A  gene amplification measured by fluorescence in situ hybridization. A total of 25 evaluable patients (15 + 10 in two steps) will be included (Simon’s two-stage minimax design). Every nine weeks, response is measured by computed tomography imaging and evaluated according to RECIST 1.1. The primary end-point of the study is progression-free survival.    Trial registration  Eudract no.  2013-001648-79 .

A phase II study of Epirubicin in oxaliplatin-resistant patients with metastatic colorectal cancer and TOP2A gene amplification