The results of the COIN-B randomised phase II trial for the treatment of advanced colorectal cancer have been published. COIN-B was looking to see if taking cetuximab either continuously or with planned breaks, alongside intermittent chemotherapy (chemotherapy with planned breaks), was safe and active against the disease. The trial found that both strategies were safe, and patients did well.
In COIN-B 169 patients were randomised to receive cetuximab in addition to chemotherapy for 12 weeks followed by either a planned break from all treatment or planned maintenance with cetuximab alone. If a patients’ disease got worse while on cetuximab alone, or during a complete treatment break, they could restart cetuximab and chemotherapy. The results show that both approaches are safe and have some effect. Continuous cetuximab during chemotherapy breaks (maintenance cetuxmab) was associated with greater effects. However, COIN-B was a phase II trial so the findings would need to be confirmed in phase III trials, as the number of patients involved is too small to draw firm conclusions.
COIN-B was one of the first trials to use information about a tumour’s genetics to decide which patients could join the trial, allowing the trial to focus on those patients who were most likely to benefit from the new drug.
We are continuing to adopt the approach of using molecular information from tumours to target treatments at those who are most likely to benefit from them. FOCUS4 is a new trial that will use genetic tumour information to help work out what sub-type of colorectal cancer patients have, and allocate them to the appropriate arms based on which treatments are most likely to work for their tumour. This new way of designing trials may help to reduce the number of patients receiving treatments that are unlikely to work for their sub-type of cancer.