New trends in oncology trials

Several publications and conferences at the end of 2011 reveal new trends in the design of clinical trials in oncology.

Personalized medicines have now been approved for many cancers and it has become routine in cancer centres to genotype patients’ tumours to determine wether they might benefit from these targeted drugs in case standard treatment fails. But now many oncologists advocate an earlier use of these personalized medicines. For instance a new trial in lung cancer is being launched by the Alliance for Clinical Trials in Oncology, a US consortium funded by the National Cancer Institute. In this trial, tumors will be genotyped after surgery to determine the presence of mutations in the gene encoding the EGF receptor. Patients with an activating mutation of that receptor can benefit from an EGF receptor inhibitor such as gefitinib (Iressa) or erlotinib (Tarceva). Some of the patients with EGF receptor mutations will take erlotinib directly after surgery, instead of waiting for cancer recurrence as previously (Nature 17 November 2011, Vol 479 : 281).

One way to accelerate the use of personalized medicines is to test them as soon as in Phase I studies, traditionally devoted to testing drug’s safety rather than efficacy. In a recent Phase I study performed at the MD Anderson Cancer Centre, patients had their tumor genotyped and those with mutation received a targeted therapy while those without mutation received a standard treatment. Response rate was much higher in the targeted therapy group (The Economist, June 9th 2011).

A similar concept was presented by Luc Dirix (Sint-Augustinus Hospital, Antwerp, Belgium) during the 14th National Conference of ACRP (Association of Clinical Research Professionals), held in Brussels in November 2011. He proposed that Phase I studies in oncology should shift from safety evaluation to target validation and proof of principle.