Chromosome 1q gain

In the AREN0533 (NCT00379340) trial, 30% of patients with stage IV pulmonary disease had 1q gain. These patients trended toward worse EFS, regardless of lung response and whether they received regimen DD-4A or M.[266] Patients in this trial with stage IV lung-only disease who had a rapid complete response to DD-4A and did not receive pulmonary radiation had a lower EFS compared with patients without 1q gain (4-year EFS rates, 57% vs. 86%; P = .0013). The 4-year OS rate, although not statistically significant, was better in patients without 1q gain compared with patients with 1q gain and pulmonary disease (97% vs. 89%; P = .16).[266] Patients who were slow incomplete responders with pulmonary-only disease and 1q gain (treated with DD-4A followed by pulmonary radiation therapy and regimen M) had 4-year EFS and OS rates of 86% and 93%, respectively. In comparison, patients with slow incomplete response without 1q gain had 4-year EFS and OS rates of 92% and 96%, respectively.[266]