Pooled Analysis Of Venous Thromboembolism (Vte) From Four Trials Of Necitumumab And Chemotherapy For Stage Iv Non-Small Cell Lung Cancer (Nsclc).

e20534 Background: Metastatic NSCLC is a recognized risk factor for VTE. Some systemic treatments may increase this risk further. Here, we present the risk of VTE and its prognostic significance in patients treated with chemotherapy (chemo) and the EGFR monoclonal antibody necitumumab (neci) for metastatic NSCLC. Methods: Four trials of 1st-line treatment for Stage IV NSCLC were included in this analysis. SQUIRE (N = 1079) and INSPIRE (N = 616) were randomized phase 3 studies of cisplatin/gemcitabine +/- neci in squamous NSCLC and cisplatin/pemetrexed +/- neci in non-squamous NSCLC, respectively. JFCL (N = 161) was a randomized phase 2 study of carboplatin/paclitaxel +/- neci in squamous NSCLC. JFCK (N = 61) was a single arm study of cisplatin/gemcitabine+neci in squamous NSCLC. VTE risk was explored in each study in univariate analyses. A Cox proportional hazards model with treatment as a fixed covariate and any VTE (prior Hx and/or on-treatment) as a time-dependent covariate was used for survival (OS) analyses. Results: On-treatment VTE across studies ranged from 3.6-8.3% for chemo alone and 3.8-13.2% for neci+chemo. Neci+chemo was associated with increased VTE risk in SQUIRE (Relative Risk [RR] 1.699; CI 1.09-2.65), INSPIRE (RR 1.58; CI 0.99-2.52), and JFCL (RR 1.04; CI 0.20-5.49) compared to chemotherapy alone. Previous Hx of VTE was the strongest predictor of VTE in SQUIRE (RR 2.63; CI 1.296-5.34) and INSPIRE (RR 1.62; CI 0.79-3.33). In SQUIRE, other baseline risk factors with RR > 1.00 included age > 65, Hb < 10 g/dL, BMI > 35 kg/m2, and current smoking. Occurrence of VTE at any time was not associated with shorter OS in randomised trials: HR 1.06; CI 0.85-1.33 (SQUIRE), HR 0.99; CI 0.76-1.27 (INSPIRE), HR 1.16; CI 0.56-2.41 (JFCL). Conclusions: VTE was more frequent in patients on neci+chemo vs chemo alone, but was not associated with shorter OS. Hx of VTE was the most significant risk factor for VTE occurrence. A pooled analysis of all 4 trials is pending.