Abstract
significant proportion of patients of lung cancer present with metastatic disease. Chemotherapy is often offered as first line treatment if patients does not have driver mutations in a specific targetable oncologic pathway and is fit to receive systemic therapy. Systemic inflammation associated with advanced cancer is often regarded as one of the factors for poor prognosis in lung cancer patients. High level of CRP and low levels of albumin are regarded as markers of systemic inflammation and prior studies have shown poor survival in such patients. It has also been shown that systemic inflammation alters the metabolism of chemotherapeutic agents resulting in either treatment failure or increased toxicity, both of which can lead to poor outcomes. This study aims to identify if increased systemic inflammatory response leads to enhanced toxicity with chemotherapeutic agents used in palliative setting in patients of metastatic lung cancer, and in turn poorer survival. Trial design Objectives Primary objective – Correlating chemotherapy toxicity with patients’ baseline albumin and CRP levels Secondary objective - Correlating CRP and Albumin levels with PFS and OS Materials and Methods Study Design - Patients with a tissue diagnosis of lung cancer will be prospectively enrolled in the study after informed consent. All clinically relevant details will be entered in a clinical proforma. Site and duration of study - Kidwai Cancer Institute; June 2018 to Dec 2019 Sample size – All patients meeting the inclusion criteria between the study time period will be included Inclusion Criteria Patients of Metastatic Biopsy Proven Lung Cancer Age 18 – 80 Planned for chemotherapy with a platin Doublet Albumin > 2.0 Exclusion Criteria Presence of targettable driver mutations Any other Synchronous / Metachronous cancer Any other uncontrolled medical comorbidities Statistical Analysis The Mann-Whitney U test and the χ2 test will be used to determine statistically significant differences 1/10/2019 #337: Correlation of Serum Albumin and CRP Levels with Chemotherapy Toxicity in Patients of Metastatic. https://cpaper.ctimeetingtech.com/elcc2019/submission/preview/print?publication_id=337 2/2 Kaplan-Meier method will be used to assess survival curves; Log-rank test to evaluate the statistical significance of differences and Cox proportional hazards model for multivariate analysis of the effect of clinicopathological factors on survival. This study aims to identify if increased systemic inflammatory response leads to enhanced toxicity with chemotherapeutic agents used in palliative setting in patients of metastatic lung cancer, and in turn poorer survival.
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