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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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with PD-L1\u2009\u2265\u200950% receiving upfront pembrolizumab (P cohort) and with PD-L1 0\u201349% treated with chemotherapy (CT cohort) were evaluated for blood SAA and radiological response at baseline and every 9\u00a0weeks. 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the P Cohort (<jats:italic>n<\/jats:italic>\u2009=\u200942), the overall RR was 38%. After a median follow-up of 18.5\u00a0months (mo), baseline SAA\u2009\u2264\u2009the ROC-derived cut-off (29.9\u00a0mg\/L;<jats:italic>n<\/jats:italic>\u2009=\u200928\/42.67%) was significantly associated with higher RR (53.6 versus 7.1%; OR15, 95% CI 1.72\u2013130.7,<jats:italic>p<\/jats:italic>\u2009=\u20090.009), longer PFS (17.4 versus 2.1 mo;<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) and OS (not reached versus 7.2mo;<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) compared with SAA\u2009&gt;\u200929.9\u00a0mg\/L. In multivariate analysis, low SAA positively affects PFS (<jats:italic>p<\/jats:italic>\u2009=\u20090.001) and OS (<jats:italic>p<\/jats:italic>\u2009=\u20090.048) irrespective of ECOG PS, number of metastatic sites and pleural effusion. SAA monitoring (<jats:italic>n<\/jats:italic>\u2009=\u200940) was also significantly associated with survival endpoints: median PFS 17.4 versus 2.1 mo and median OS not reached versus 7.2 mo when SAA remained low (<jats:italic>n<\/jats:italic>\u2009=\u200914) and high (<jats:italic>n<\/jats:italic>\u2009=\u200912), respectively. In the CT Cohort (<jats:italic>n<\/jats:italic>\u2009=\u200930), RR was not affected by SAA level (<jats:italic>p<\/jats:italic>\u2009&gt;\u20090.05) while low SAA at baseline (<jats:italic>n<\/jats:italic>\u2009=\u200917) was associated with better PFS (HR 0.38, 95% CI 0.16\u20130.90,<jats:italic>p<\/jats:italic>\u2009=\u20090.006) and OS (HR 0.25, 95% CI 0.09\u20130.67,<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Low SAA predicts good survival outcomes irrespective of treatment for advanced NSCLC patients and higher likelihood of response to upfront pembrolizumab only. The strong prognostic value might be exploited to easily identify patients most likely to benefit from immunotherapy. A further study (FoRECATT-2) is ongoing to confirm results in a larger sample size and to investigate the effect of SAA on immune response in vitro assays.<\/jats:p><\/jats:sec>","DOI":"10.1007\/s00262-020-02788-1","type":"journal-article","created":{"date-parts":[[2020,11,24]],"date-time":"2020-11-24T09:03:01Z","timestamp":1606208581000},"page":"1583-1592","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["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 \u201cFoRECATT\u201d study"],"prefix":"10.1007","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2009-5791","authenticated-orcid":false,"given":"Vincenzo","family":"Di Noia","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ettore","family":"D\u2019Argento","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Pilotto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Vita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam Grazia","family":"Ferrara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Damiano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Ribelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Cannella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Virtuoso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Fattorossi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni Luca","family":"Ceresoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Milella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giordano Domenico","family":"Beretta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giampaolo","family":"Tortora","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Bria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,24]]},"reference":[{"key":"2788_CR1","doi-asserted-by":"publisher","first-page":"976","DOI":"10.1158\/1078-0432.CCR-14-1187","volume":"21","author":"VK Anagnostou","year":"2015","unstructured":"Anagnostou VK, Brahmer JR (2015) Cancer immunotherapy: a future paradigm shift in the treatment of non-small cell lung cancer. 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V.D.N. received grant consultancies by Astrazeneca, MSD, BMS, Boehringer Ingelheim and travels\u2019 fee from MSD and Boehringer Ingelheim. V.D.N. received institutional research grants from Roche. E.B. received speakers\u2019 and travels\u2019 fee from MSD, Astra-Zeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis and Roche. E.B received consultant\u2019s fee from Roche, Pfizer. E.B. received institutional research grants from Astra-Zeneca, Roche.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}