Blood serum amyloid A as potential biomarker of pembrolizumab efficacy for patients affected by advanced non-small cell

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ORIGINAL ARTICLE

Blood serum amyloid A as potential biomarker of pembrolizumab efficacy for patients affected by advanced non‑small cell lung cancer overexpressing PD‑L1: results of the exploratory “FoRECATT” study Vincenzo Di Noia1,2   · Ettore D’Argento3 · Sara Pilotto4 · Emanuele Vita1 · Miriam Grazia Ferrara1 · Paola Damiano1 · Marta Ribelli1 · Antonella Cannella1 · Antonella Virtuoso1 · Andrea Fattorossi5 · Giovanni Luca Ceresoli2 · Michele Milella4 · Giordano Domenico Beretta2 · Giampaolo Tortora1,3 · Emilio Bria1,3 Received: 1 September 2020 / Accepted: 3 November 2020 © The Author(s) 2020

Abstract Background  Identifying the patients who may benefit the most from immune checkpoints inhibitors remains a great challenge for clinicians. Here we investigate on blood serum amyloid A (SAA) as biomarker of response to upfront pembrolizumab in patients with advanced non-small-cell lung cancer (NSCLC). Methods  Patients with PD-L1 ≥ 50% receiving upfront pembrolizumab (P cohort) and with PD-L1 0–49% treated with chemotherapy (CT cohort) were evaluated for blood SAA and radiological response at baseline and every 9 weeks. Endpoints were response rate (RR) according to RECIST1.1, progression-free (PFS) and overall survival (OS). The most accurate SAA cut-off to predict response was established with ROC analysis in the P cohort. Results  In the P Cohort (n = 42), the overall RR was 38%. After a median follow-up of 18.5 months (mo), baseline SAA ≤ the ROC-derived cut-off (29.9 mg/L; n = 28/42.67%) was significantly associated with higher RR (53.6 versus 7.1%; OR15, 95% CI 1.72–130.7, p = 0.009), longer PFS (17.4 versus 2.1 mo; p  0.05) while low SAA at baseline (n = 17) was associated with better PFS (HR 0.38, 95% CI 0.16–0.90, p = 0.006) and OS (HR 0.25, 95% CI 0.09–0.67, p