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      Prognostic value of plasminogen activator inhibitor‐1 in biomarker exploration using multiplex immunoassay in patients with metastatic renal cell carcinoma treated with axitinib

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          Abstract

          Background and Aims

          Vascular endothelial growth factor‐directed therapies play a significant role in patients with metastatic renal cell carcinoma (mRCC). Biomarkers for predicting treatment efficacy and resistance are required to develop personalized medicine. We evaluated multiple serum cytokine levels in patients with mRCC treated with axitinib to explore predictive biomarkers.

          Methods

          From September 2012 to October 2015, serum samples were collected from 44 patients with mRCC before treatment and 4 weeks after axitinib initiation. Bio‐Plex Pro Human Cancer Biomarker Panels 1 and 2 were used to measure levels of 34 serum biomarkers related to angiogenesis and cell proliferation.

          Results

          Patients with partial response or stable disease had significantly decreased serum plasminogen activator inhibitor‐1 (PAI‐1) level from pre‐treatment to 4 weeks after axitinib initiation compared with those with progressive disease ( P = .022). The median progression‐free survival (PFS) and median overall survival (OS) in patients with increased serum PAI‐1 level from pre‐treatment to 4 weeks after axitinib initiation were significantly shorter than those with decreased serum PAI‐1 level ( P = .027 and P = .026, respectively). Increased serum PAI‐1 level from pre‐treatment to 4 weeks after axitinib initiation was an independent prognostic marker for shorter PFS and OS in multivariate analyses ( P = .015 and P = .032, respectively). The immunohistochemical staining intensity of PAI‐1 in tumor specimens was significantly associated with Fuhrman grade and presence of distant metastasis ( P = .026 and P = .010, respectively).

          Conclusions

          The initial change in serum PAI‐1 level in the early stage of axitinib treatment could be a useful prognostic biomarker in patients with mRCC.

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          Most cited references32

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          Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial.

          Robert Motzer, Bernard Escudier, Piotr Tomczak … (2013)
          In a phase 3 trial comparing the efficacy and safety of axitinib versus sorafenib as second-line treatment for metastatic renal cell carcinoma, patients given axitinib had a longer progression-free survival (PFS). Here, we report overall survival and updated efficacy, quality of life, and safety results. Eligible patients had clear cell metastatic renal cell carcinoma, progressive disease after one approved systemic treatment, and an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. 723 patients were stratified by ECOG PS and previous treatment and randomly allocated (1:1) to receive axitinib (5 mg twice daily; n=361) or sorafenib (400 mg twice daily; n=362). The primary endpoint was PFS assessed by a masked, independent radiology review committee. We assessed patient-reported outcomes using validated questionnaires. Baseline characteristics and development of hypertension on treatment were studied as prognostic factors. Efficacy was assessed in the intention-to-treat population, and safety was assessed in patients who received at least one dose of the study drug. This ongoing trial is registered on ClinicalTrials.gov, number NCT00678392. Median overall survival was 20.1 months (95% CI 16.7-23.4) with axitinib and 19.2 months (17.5-22.3) with sorafenib (hazard ratio [HR] 0.969, 95% CI 0.800-1.174; one-sided p=0.3744). Median investigator-assessed PFS was 8.3 months (95% CI 6.7-9.2) with axitinib and 5·7 months (4.7-6.5) with sorafenib (HR 0.656, 95% CI 0.552-0.779; one-sided p<0.0001). Patient-reported outcomes scores were similar in the treatment groups at baseline, were maintained during treatment, but decreased at end-of-treatment. Common grade 3 or higher treatment-related adverse events were hypertension (60 [17%]), diarrhoea (40 [11%]), and fatigue (37 [10%]) in 359 axitinib-treated patients and hand-foot syndrome (61 [17%]), hypertension (43 [12%]), and diarrhoea (27 [8%]) in 355 sorafenib-treated patients. In a post-hoc 12-week landmark analysis, median overall survival was longer in patients with a diastolic blood pressure of 90 mm Hg or greater than in those with a diastolic blood pressure of less than 90 mm Hg: 20.7 months (95% CI 18.4-24.6) versus 12.9 months (10.1-20.4) in the axitinib group (p=0.0116), and 20.2 months (17.1-32.0) versus 14.8 months (12.0-17.7) in the sorafenib group (one-sided p=0.0020). Although overall survival, a secondary endpoint for the study, did not differ between the two groups, investigator-assessed PFS remained longer in the axitinib group compared with the sorafenib group. These results establish axitinib as a second-line treatment option for patients with metastatic renal cell carcinoma. Pfizer Inc. Copyright © 2013 Elsevier Ltd. All rights reserved.
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            Systemic Treatment of Metastatic Clear Cell Renal Cell Carcinoma in 2018: Current Paradigms, Use of Immunotherapy, and Future Directions

            Aly-Khan Lalani, Bradley A McGregor, Laurence Albiges … (2019)
            Systemic therapy for metastatic clear cell renal cell carcinoma (mccRCC) has greatly evolved over the last 15yr. More recently, combination strategies involving contemporary immunotherapy have emerged as key opportunities to further shift the treatment landscape.
            Article 0 comments Cited 87 times – based on 0 reviews     Review now
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              Age-adjusted incidence, mortality, and survival rates of stage-specific renal cell carcinoma in North America: a trend analysis.

              Francesco Montorsi, Jan Schmitges, P. Perrotte … (2011)
              The rising incidence of renal cell carcinoma (RCC) has been largely attributed to the increasing use of imaging procedures. Our aim was to examine stage-specific incidence, mortality, and survival trends of RCC in North America. We computed age-adjusted incidence, survival, and mortality rates using the Surveillance Epidemiology and End Results database. Between 1988 and 2006, 43,807 patients with histologically confirmed RCC were included. We calculated incidence, mortality, and 5-yr survival rates by year. Reported findings were stratified according to disease stage. Age-adjusted incidence rate of RCC rose from 7.6 per 100,000 person-years in 1988 to 11.7 in 2006 (estimated annual percentage change [EAPC]: +2.39%; p<0.001). Stage-specific age-adjusted incidence rates increased for localized stage: 3.8 in 1988 to 8.2 in 2006 (EAPC: +4.29%; p<0.001) and decreased during the same period for distant stage: 2.1 to 1.6 (EAPC: -0.57%; p=0.01). Stage-specific survival rates improved over time for localized stage but remained stable for regional and distant stages. Mortality rates varied significantly over the study period among localized stage, 1.3 in 1988 to 2.4 in 2006 (EAPC: +3.16%; p<0.001), and distant stage, 1.8 in 1988 to 1.6 in 2006 (EAPC: -0.53%; p=0.045). Better detailed staging information represents a main limitation of the study. The incidence rates of localized RCC increased rapidly, whereas those of distant RCC declined. Mortality rates significantly increased for localized stage and decreased for distant stage. Innovation in diagnosis and management of RCC remains necessary. Copyright © 2010 European Association of Urology. All rights reserved.
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                Author and article information

                Contributors
                Takamitsu Inoue:
                ORCID: https://orcid.org/0000-0002-1362-4344
                takmitz@gmail.com , takmitz@iuhw.ac.jp
                Journal
                Journal ID (nlm-ta): Health Sci Rep
                Journal ID (iso-abbrev): Health Sci Rep
                Journal ID (doi): 10.1002/(ISSN)2398-8835
                Journal ID (publisher-id): HSR2
                Title: Health Science Reports
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2398-8835
                Publication date (Electronic): 15 October 2020
                Publication date Collection: December 2020
                Volume: 3
                Issue: 4 ( doiID: 10.1002/hsr2.v3.4 )
                Electronic Location Identifier: e197
                Affiliations
                [ 1 ] Department of Urology Akita University Graduate School of Medicine Akita Japan
                [ 2 ] AMED‐CREST Japan Science and Technology Agency Tokyo Japan
                [ 3 ] Department of Urology Yamagata University Faculty of Medicine Yamagata Japan
                [ 4 ] Center for Kidney Disease and Transplantation Akita University Hospital Akita Japan
                Author notes
                [*] [* ] Correspondence

                Takamitsu Inoue, Department of Renal and Urological Surgery, International University of Health and Welfare Narita Hospital, 852 Hatakeda, Narita, Chiba 286‐0124, Japan.

                Email: takmitz@ 123456gmail.com ; takmitz@ 123456iuhw.ac.jp

                Author information
                https://orcid.org/0000-0002-1362-4344
                https://orcid.org/0000-0002-5899-1738
                Article
                Publisher ID: HSR2197
                DOI: 10.1002/hsr2.197
                PMC ID: 7559632
                SO-VID: 9088229c-0fda-4e15-919e-9a5071f6bd6b
                Copyright © © 2020 The Authors. Health Science Reports published by Wiley Periodicals LLC.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 13 April 2020
                Date revision received : 24 August 2020
                Date accepted : 17 September 2020
                Page count
                Figures: 1, Tables: 5, Pages: 11, Words: 6324
                Funding
                Funded by: Japanese Society for the Promotion of Science
                Award ID: 16H02679
                Award ID: 23590168
                Award ID: 25293332
                Categories
                Subject: Research Article
                Subject: Research Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date December 2020
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.2 mode:remove_FC converted:15.10.2020

                Keywords: metastatic renal cell carcinoma,molecular‐targeted therapy,plasminogen activator inhibitor‐1,serum biomarker
                Data availability:
                Keywords: metastatic renal cell carcinoma, molecular‐targeted therapy, plasminogen activator inhibitor‐1, serum biomarker

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