The long-term efficacy of nivolumab in esophageal squamous cell carcinoma and its association with disease biomarkers are currently not well known. Therefore, we investigated the association in Japanese patients with treatment-refractory advanced esophageal cancer who participated in an open-label, single-arm, multicenter phase 2 study. Patients received nivolumab 3 mg/kg, intravenously every 2 weeks until disease progression or unacceptable toxicity, and were followed up for 2 years after the initial dosing of the last patient. Tissue samples were collected before treatment, and analyzed for PD-L1, CD8+ of tumor and tumor infiltrating lymphocytes (TILs) and HLA class 1. Efficacy endpoints included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), time to response and duration of response. Of 65 enrolled patients (83% male), 64 were evaluable for efficacy and 41 (63%) for biomarkers. The ORR, median OS, and survival rate were 17.2%, 10.78 months, and 17.2%, respectively. Time to response was 1.45 months and duration of response was 11.17 months. PD-L1 positivity of tumor cell was possibly associated with better PFS (2.04 vs 1.41 months, cut-off 1%) and OS (11.33 vs 6.24 months, cut-off 1%). Median OS was prolonged in patients with a median number of TILs >63.75% versus ≤63.75% (11.33 vs 7.85 months). Nivolumab demonstrated continued long-term efficacy, as seen by the stability of PFS and OS, in Japanese patients with esophageal squamous cell carcinoma. Further investigation of PD-L1 tumor expression and TILs as potential biomarkers for predicting patients likely to benefit from nivolumab therapy is warranted.This article is protected by copyright. All rights reserved.
Impact of Carotid Endarterectomy on Choroidal Thickness and Volume in Enhanced Depth Optical Coherence Tomography Imaging.
April 14, 2020
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