Abstract 112P
Background
Patients diagnosed with NSCLC usually present with advanced disease and median overall survival (OS) of 12 months, extending up to 30 months with chemotherapy/immunotherapy combinations. Serum biomarkers (SB) may offer a cost-effective and non-invasive option for patient monitoring and stratification. Five measured SB: C-reactive protein (CRP), carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), interleukin-6 (IL-6), and soluble cytokeratin 19 fragment (CYFRA 21-1) were evaluated for their correlation with progression-free survival (PFS) and OS.
Methods
SB data were obtained from 262 advanced NSCLC patients enrolled in the CEPAC-TDM study who received paclitaxel 3-weekly in combination with either carboplatin or cisplatin. Data were measured on day 1 of cycles 1 (baseline), 2, and 3; day 2 of cycles 1 and 2; and at the end of first-line chemotherapy. For IL-6, only baseline data were available. A non-parametric Kaplan-Meier analysis was applied to test the significance of the relation between baseline SB (dichotomised based on the median value or divided into quartiles) and PFS, and OS. Association of baseline or all measured concentrations of SB with PFS and OS was determined by semi-parametric univariate cox-proportional hazards modelling. Analyses were performed in R.
Results
High baseline CRP and LDH were significantly and independently associated with a lower PFS (hazard ratio (HR) 1.29 [1.11-1.52], 1.69 [1.17-2.45], respectively; p-value ≤ 0.008) and a lower OS (HR 1.44 [1.27-1.63], 1.76 [1.31-2.36], respectively; p-value ≤ 3e-4; 6.4 month decrease in median OS with CRP). For IL-6, high baseline was significantly associated with a lower OS (HR 1.32 [1.12-1.54], p-value 7e-4, 6.4 month decrease in median OS) but not with PFS. All measured concentrations of CRP, LDH and CYFRA 21-1 significantly correlated with PFS and OS, CEA with PFS, only.
Conclusions
We confirmed the bad prognosis linked to high CRP or LDH concentrations in patients with advanced NSCLC receiving platinum-based paclitaxel first-line chemotherapy, independently. Additional prognostic value for baseline IL-6 was observed with OS but not PFS. Neither CEA nor CYFRA 21-1 baseline significantly correlated with survival.
Clinical trial identification
EudraCT: 2010-023688-16.
Editorial acknowledgement
Legal entity responsible for the study
Central European Society for Anticancer Drug Research (CESAR).
Funding
Saladax.
Disclosure
S. Holdenrieder: Financial Interests, Institutional, Funding, outside the submitted work: Roche Diagnostics; Financial Interests, Institutional, Principal Investigator, outside the submitted work: Roche Diagnostics; Financial Interests, Personal, Invited Speaker, outside the submitted work: Roche Diagnostics; Financial Interests, Institutional, Funding, outside the submitted work: Volition SRL; Financial Interests, Institutional, Principal Investigator, outside the submitted work: Volition SRL; Financial Interests, Personal, Member, SAB member, consultant, outside the submitted work: Volition SRL; Financial Interests, Personal, Invited Speaker, outside the submitted work: Sysmex-Inostics; Financial Interests, Personal, Invited Speaker, outside the submitted work: Merck. W. Huisinga: Financial Interests, Institutional, Funding, AbbVie, AstraZeneca, Boehringer Ingelheim, Grünenthal, F. Hoffmann-La Roche, Merck KGaA, Sanofi: Industry consortium for the PharMetrX program. C. Kloft: Financial Interests, Institutional, Funding, AbbVie, AstraZeneca, Boehringer Ingelheim, Grünenthal, F. Hoffmann-La Roche, Merck KGaA, Sanofi: Industry consortium for the PharMetrX program; Financial Interests, Institutional, Research Grant, Innovative Medicines Initiative-Joint Undertaking (‘DDMoRe’), all outside the submitted work: Federal Ministry of Education and Research as well as the European Commission. All other authors have declared no conflicts of interest.