Background of the study
Panitumumab is an anti-EGFR monoclonal antibody that inhibits the action of the receptor for the epidermal growth factor (EGFR), involved in the mechanism of proliferation, differentiation and survival of tumor cells. The use of EGFR inhibitors in combination with chemotherapeutic regimens with two drugs (so-called doublets) is a valid option in patients without mutations in the RAS and BRAF genes. Clinical experience and results from trials have taught that only a subset of patients may benefit from anti-EGFR antibodies. In particular, patients with mutations in the RAS genes are intrinsically resistant, while the impact of anti-EGFR in patients with BRAF mutation is minimal.
Moreover, clinical trials leading to the demonstration of efficacy of available drugs include only a small percentage of elderly patients and there is a substantial lack of evidence about the safety and effectiveness of anti-EGFR in this kind of population.
Furthermore, the combination of a less intense chemotherapy, the ideal approach for elderly patients, i.e. the so-called monotherapy, with anti-EGFR drugs was evaluated only in small trials, conducted before the evidence of the need for an accurate molecular selection to optimize the effectiveness of these drugs.
Aim of the study
Our study aims at evaluating the treatment with monotherapy (5-fluorouracil) in combination with panitumumab compared with panitumumab in association with the the standard doublet of chemotherapy FOLFOX in elderly patients selected on the basis of the molecular profile of their tumors. It will be also important to assess the impact in terms of quality of life of the two treatments in this subset of patients.