Background: Candidate predictive biomarkers for epidermal growth factor receptor inhibitors (EGFRi), skin rash and\r\nserum proteomic assays, require further qualification to improve EGFRi therapy in non-small cell lung cancer\r\n(NSCLC). In a phase II trial that was closed to accrual because of changes in clinical practice we examined the\r\nrelationships among candidate biomarkers, quantitative changes in tumor size, progression-free and overall survival.\r\nMethods: 55 patients with progressive NSCLC after platinum therapy were randomized to receive (Arm A)\r\ncetuximab, followed by pemetrexed at progression, or (Arm B) concurrent cetuximab and pemetrexed. All received\r\ncetuximab monotherapy for the first 14 days. Pre-treatment serum and weekly rash assessments by standard and\r\nEGFRi-induced rash (EIR) scales were collected.\r\nResults: 43 patients (20-Arm A, 23-Arm B) completed the 14-day run-in. Median survival was 9.1 months. Arm B\r\nhad better median overall (Arm B = 10.3 [95% CI 7.5, 16.8]; Arm A = 3.5 [2.8, 11.7] months P = 0.046) and\r\nprogression-free survival (Arm B = 2.3 [1.6, 3.1]; Arm A = 1.6 [0.9, 1.9] months P = 0.11). The EIR scale distributed\r\nratings among 6 rather than 3 categories but ordinal scale rash severity did not predict outcomes. The serum\r\nproteomic classifier and absence of rash after 21 days of cetuximab did.\r\nConclusions: Absence of rash after 21 days of cetuximab therapy and the serum proteomic classifier, but not\r\nordinal rash severity, were associated with NSCLC outcomes. Although in a small study, these observations were\r\nconsistent with results from larger retrospective analyses
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