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Impact of renal function on treatment options and outcomes in advanced non-small cell lung cancer.

ABSTRACT: Certain chemotherapeutic agents commonly used for advanced non-small cell lung cancer (NSCLC) require minimum threshold renal function for administration. To determine how such requirements affect treatment options, we evaluated renal function patterns in this population.We performed a single-center retrospective analysis of patients treated for stage IV NSCLC from 2000 to 2007. Associations between patient characteristics, calculated creatinine clearance (CrCl), and clinical outcomes were determined using univariate and multivariate analyses, Cox proportional hazard models, and mixed model analysis.298 patients (3930 creatinine measurements) were included in the analysis. Patients had a median of 5 (interquartile range [IQR] 4-18) Cr measurements. Median baseline CrCl was 96 mL/min (IQR 74-123 mL/min); median nadir CrCl was 78 mL/min (IQR 56-100mL/min). Renal function was associated with age (P<0.001), race (P=0.009), and gender (P=0.001). 23% of patients had a recorded CrCl<60 mL/min (threshold for cisplatin), with median onset 83 days after diagnosis and median time to recover to ?60 mL/min of 27 (IQR 3-85) days; 11% of patients had a recorded CrCl<45 mL/min (threshold for pemetrexed), with median onset 122 days after diagnosis and median recovery time of 36 (IQR 3-73) days. For both thresholds, approximately 35% of patients had no documented recovery.In this cohort of patients treated for stage IV NSCLC, renal function falls below commonly used thresholds for cisplatin and for pemetrexed in fewer than a quarter of patients. However, these declines may preclude administration of these drugs for prolonged periods.

SUBMITTER: Kutluk Cenik B

PROVIDER: S-EPMC3646907 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Impact of renal function on treatment options and outcomes in advanced non-small cell lung cancer.

Kutluk Cenik Bercin B Sun Han H Gerber David E DE

Lung cancer (Amsterdam, Netherlands) 20130315 3

<h4>Introduction</h4>Certain chemotherapeutic agents commonly used for advanced non-small cell lung cancer (NSCLC) require minimum threshold renal function for administration. To determine how such requirements affect treatment options, we evaluated renal function patterns in this population.<h4>Methods</h4>We performed a single-center retrospective analysis of patients treated for stage IV NSCLC from 2000 to 2007. Associations between patient characteristics, calculated creatinine clearance (Cr ...[more]

PMID: 23499397

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Project description:PurposeThird-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have demonstrated potent activity against TKI resistance mediated by EGFR T790M. We studied whether noninvasive genotyping of cell-free plasma DNA (cfDNA) is a useful biomarker for prediction of outcome from a third-generation EGFR-TKI, osimertinib.MethodsPlasma was collected from all patients in the first-in-man study of osimertinib. Patients who were included had acquired EGFR-TKI resistance and evidence of a common EGFR-sensitizing mutation. Genotyping of cell-free plasma DNA was performed by using BEAMing. Plasma genotyping accuracy was assessed by using tumor genotyping from a central laboratory as reference. Objective response rate (ORR) and progression-free survival (PFS) were analyzed in all T790M-positive or T790M-negative patients.ResultsSensitivity of plasma genotyping for detection of T790M was 70%. Of 58 patients with T790M-negative tumors, T790M was detected in plasma of 18 (31%). ORR and median PFS were similar in patients with T790M-positive plasma (ORR, 63%; PFS, 9.7 months) or T790M-positive tumor (ORR, 62%; PFS, 9.7 months) results. Although patients with T790M-negative plasma had overall favorable outcomes (ORR, 46%; median PFS, 8.2 months), tumor genotyping distinguished a subset of patients positive for T790M who had better outcomes (ORR, 69%; PFS, 16.5 months) as well as a subset of patients negative for T790M with poor outcomes (ORR, 25%; PFS, 2.8 months).ConclusionIn this retrospective analysis, patients positive for T790M in plasma have outcomes with osimertinib that are equivalent to patients positive by a tissue-based assay. This study suggests that, upon availability of validated plasma T790M assays, some patients could avoid a tumor biopsy for T790M genotyping. As a result of the 30% false-negative rate of plasma genotyping, those with T790M-negative plasma results still need a tumor biopsy to determine presence or absence of T790M.

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Impact of renal function on treatment options and outcomes in advanced non-small cell lung cancer.

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Impact of renal function on treatment options and outcomes in advanced non-small cell lung cancer.

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