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      Efficacy and Safety of Anti-PD-1 Plus Anlotinib in Patients With Advanced Non–Small-Cell Lung Cancer After Previous Systemic Treatment Failure—A Retrospective Study

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          Abstract

          Background

          Pre-clinical and clinical evidences support that simultaneous blockade of programmed death-1 (PD-1) and vascular endothelial growth factor receptor (VEGFR) can enhance antigen-specific T-cell migration, and show tolerable toxicity with favorable antitumor activity in patients. In this study, we aimed to assess the safety and efficacy of anlotinib, a novel multitarget tyrosine kinase inhibitor for VEGFR, platelet-derived growth receptor (PDGFR), and the stem cell-factor receptor (c-Kit), combined with anti-PD-1 treatment in patients with advanced NSCLC.

          Methods

          Sixty-seven patients with previously treated advanced NSCLC receiving anti-PD-1 agents concomitant with anlotinib were retrospectively enrolled in an IRB approved study. Anti-PD-1 agents including pembrolizumab, nivolumab, camrelizumab, toripalimab, sintilimab, and tislelizumab were administered every two or three weeks until disease progression or unacceptable toxicity was reached. Anlotinib was administered orally once daily on days 1–14 of a 21-day cycle. The safety and tolerability of the combination treatment were assessed by the incidence of adverse events. The efficacy of the treatment was assessed by the tumor response and survival.

          Results

          With a median follow-up period of 8.7 months, treatment-related adverse events occurred in 85% (57/67) of patients and grade 3–4 adverse events were observed in 27 patients (40%). No unexpected adverse events or significantly increased toxicities were observed. Complete response was not observed, 19 patients had partial response (28.4%), 39 had stable disease (58.2%) and 9 had progressive disease (13.4%). The overall response (ORR) and disease control rates (DCR) were 28.4% and 86.6%, respectively. The median progression-free survival (PFS) was 6.9 months (95% CI, 5.5-8.3 months) and overall survival (OS) was 14.5 months (95% CI, 10.9-18.1 months). The benefit of anti-PD-1 plus anlotinib was also observed in patients with EGFR mutation positive, liver metastases and brain metastases.

          Conclusion

          Anti-PD-1 treatment concomitant with anlotinib has tolerable toxicity and favorable antitumor activity in patients with previously treated advanced NSCLC. Our results add to the growing evidence that supports the benefits of combining immunotherapy with antiangiogenic drugs. This combination could be further evaluated with or without chemotherapy, since no additional toxicity was observed in the combination treatment.

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          Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

          Martin Reck, Delvys Rodriguez-Abreu, Andrew G Robinson … (2016)
          Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
          Article 0 comments Cited 2483 times – based on 0 reviews     Review now
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            Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

            Hossein Borghaei, Luis Paz-Ares, Leora Horn … (2015)
            Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.
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              Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer

              Rina Hui, Takayasu Kurata, Silvia Novello … (2018)
              First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial.
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                Author and article information

                Contributors
                Journal
                Journal ID (nlm-ta): Front Oncol
                Journal ID (iso-abbrev): Front Oncol
                Journal ID (publisher-id): Front. Oncol.
                Title: Frontiers in Oncology
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 2234-943X
                Publication date (Electronic): 15 March 2021
                Publication date Collection: 2021
                Volume: 11
                Electronic Location Identifier: 628124
                Affiliations
                [1] 1Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Cheeloo College of Medicine, Shandong University , Jinan, China
                [2] 2Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences , Jinan, China
                [3] 3Department of Hepatobiliary Surgery, Shandong Cancer Hospital and Institute, Cheeloo College of Medicine, Shandong University , Jinan, China
                Author notes

                Edited by: Qibin Song, Renmin Hospital of Wuhan University, China

                Reviewed by: Xuchao Zhang, Guangdong Provincial People’s Hospital, China; Alessandro Morabito, Istituto Nazionale Tumori Fondazione G. Pascale (IRCCS), Italy

                *Correspondence: Feifei Teng, tengfeifei16@ 123456126.com

                This article was submitted to Thoracic Oncology, a section of the journal Frontiers in Oncology

                Article
                DOI: 10.3389/fonc.2021.628124
                PMC ID: 8005709
                PubMed ID: 33791214
                SO-VID: f3cce6a0-c31f-41b7-87e0-ec41ab352479
                Copyright © Copyright © 2021 Wang, Fang, Yin, Tian, Yu and Teng
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 11 November 2020
                Date accepted : 25 February 2021
                Page count
                Figures: 3, Tables: 4, Equations: 0, References: 33, Pages: 8, Words: 3792
                Categories
                Subject: Oncology
                Subject: Original Research

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: anlotinib,anti-pd-1,non–small cell lung cancer,combination therapy,immune checkpoint inhibitors
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: anlotinib, anti-pd-1, non–small cell lung cancer, combination therapy, immune checkpoint inhibitors

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