Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancerReportar como inadecuado




Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancer - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Cancer

, 14:5

Clinical oncology

Abstract

BackgroundCandidate predictive biomarkers for epidermal growth factor receptor inhibitors EGFRi, skin rash and serum proteomic assays, require further qualification to improve EGFRi therapy in non-small cell lung cancer NSCLC. In a phase II trial that was closed to accrual because of changes in clinical practice we examined the relationships among candidate biomarkers, quantitative changes in tumor size, progression-free and overall survival.

Methods55 patients with progressive NSCLC after platinum therapy were randomized to receive Arm A cetuximab, followed by pemetrexed at progression, or Arm B concurrent cetuximab and pemetrexed. All received cetuximab monotherapy for the first 14 days. Pre-treatment serum and weekly rash assessments by standard and EGFRi-induced rash EIR scales were collected.

Results43 patients 20-Arm A, 23-Arm B completed the 14-day run-in. Median survival was 9.1 months. Arm B had 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 progression-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 ratings among 6 rather than 3 categories but ordinal scale rash severity did not predict outcomes. The serum proteomic classifier and absence of rash after 21 days of cetuximab did.

ConclusionsAbsence of rash after 21 days of cetuximab therapy and the serum proteomic classifier, but not ordinal rash severity, were associated with NSCLC outcomes. Although in a small study, these observations were consistent with results from larger retrospective analyses.

Trial registrationClinicaltrials.gov Identifier NCT00203931

KeywordsPemetrexed Lung Cancer Cetuximab Rash EGFR Proteomics Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-5 contains supplementary material, which is available to authorized users.

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Autor: Michael L Maitland - Matthew R Levine - Mario E Lacouture - Kristen E Wroblewski - Christine H Chung - Ilyssa O Gordon

Fuente: https://link.springer.com/







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