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      Propensity score analysis of overall survival between first‐ and second‐generation EGFR‐TKIs using real‐world data

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          Abstract

          We constructed a data set of EGFR‐mutant non–small‐cell lung carcinoma (NSCLC) patients, and compared the overall survival of first‐generation (1G), and second‐generation (2G) EGFR‐tyrosine kinase inhibitors (TKIs) in clinical practice using a propensity score. We reviewed the clinical data of consecutive EGFR‐mutated NSCLC patients who received EGFR‐TKI therapy between January 2008 and August 2017 at 11 institutions in Japan. The primary endpoint was overall survival (OS). When comparing OS between 1G and 2G EGFR‐TKIs, propensity score analyses were performed using 2 methods: matching and inverse probability of treatment weighting (IPTW). (Clinical Trial information: UMIN000030121) In total, 1400 patients from 11 institutions were enrolled in this study, and the data from the 1366 patients who received only EGFR‐TKI therapy were analyzed (gefitinib [GEF], N = 732; erlotinib [ERL], N = 416; afatinib, N = 218). Median OS times (months [95%CI]) were 29.7 [27.5‐33.5] in the 1G group (gefitinib, 32.0 [28.1‐35.8]; erlotinib, 27.5 [23.9‐31.7]), and 38.6 [32.2‐NR] in the 2G group (afatinib), respectively. The trend of longer OS for afatinib against 1G EGFR‐TKIs remained, even after adjusted by propensity score. (unadjusted, hazard ratio [HR] 0.676, P = .0023; adjusted by IPTW, HR 0.685 P < .0001; adjusted by matching, HR 0.725, P = .0418). Exploratory analysis showed that OS using the 2G EGFR‐TKI was superior to that of the 1G EGFR‐TKIs, suggesting the potential of sequential therapy of 2G EGFR‐TKI followed by osimertinib. (HR 0.419, P = .0519) Real‐world data analysis using 1354 data records, using propensity scoring, indicated that 2G EGFR‐TKI had a trend of longer OS compared with 1G EGFR‐TKIs.

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          Erlotinib plus bevacizumab versus erlotinib alone in patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026): interim analysis of an open-label, randomised, multicentre, phase 3 trial

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            Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial

            Dual blockade of the EGFR and VEGF pathways in EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) is supported by preclinical and clinical data, yet the approach is not widely implemented. RELAY assessed erlotinib, an EGFR tyrosine kinase inhibitor (TKI) standard of care, plus ramucirumab, a human IgG1 VEGFR2 antagonist, or placebo in patients with untreated EGFR-mutated metastatic NSCLC.
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              Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study

              To assess outcomes in patients with EGFR mutation-positive (Del19, L858R) non-small-cell lung cancer receiving sequential afatinib and osimertinib in a real-world clinical setting. Materials & methods: In this retrospective, observational, multicenter study, patients (n = 204) had T790M-positive disease following first-line afatinib and started osimertinib treatment ≥10 months prior to data entry. Primary outcome was time on treatment.
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                Author and article information

                Contributors
                tatyoshi@ncc.go.jp
                Journal
                Cancer Sci
                Cancer Sci
                10.1111/(ISSN)1349-7006
                CAS
                Cancer Science
                John Wiley and Sons Inc. (Hoboken )
                1347-9032
                1349-7006
                05 August 2020
                October 2020
                : 111
                : 10 ( doiID: 10.1111/cas.v111.10 )
                : 3705-3713
                Affiliations
                [ 1 ] Respiratory Center Matsusaka Municipal Hospital Matsusaka city Japan
                [ 2 ] Biostatistics Center Kurume University Kurume city Japan
                [ 3 ] Division of Respiratory Medicine and Allergology Aichi Medical University School of Medicine Nagakute Japan
                [ 4 ] Department of Respiratory Medicine, Respiratory Tract Oncology Center Nagoya City West Medical Center Nagoya City Japan
                [ 5 ] Department of Internal Medicine Toyama Prefectural Central Hospital Toyama city Japan
                [ 6 ] Department of Respiratory Medicine Ogaki Municipal Hospital Ogaki Japan
                [ 7 ] Department of Respiratory Medicine Shizuoka General Hospital Shizuoka city Japan
                [ 8 ] Department of Respiratory Medicine Fujita Health University School of Medicine Toyoake Japan
                [ 9 ] Department of Respiratory Medicine Aichi Cancer Center Aichi Hospital Okazaki‐shi Japan
                [ 10 ] Department of Respiratory Medicine Anjo Kosei Hospital Anjo‐city Japan
                [ 11 ] Second Division Department of Internal Medicine Hamamatsu University School of Medicine Hamamatsu city Japan
                [ 12 ] Department of Respiratory Medicine Okazaki City Hospital Okazaki‐shi Japan
                [ 13 ] Department of Clinical Pharmacology and Therapeutics Hamamatsu University School of Medicine Hamamatsu city Japan
                [ 14 ] Department of Respiratory Medicine Nagoya University Graduate School of Medicine Nagoya Japan
                [ 15 ] Department of Respiratory Medicine and Allergy Tosei General Hospital Seto City Japan
                [ 16 ] Department of Thoracic Oncology Aichi Cancer Center Hospital Nagoya Japan
                [ 17 ] Department of Thoracic Oncology National Cancer Center Hospital Chuo‐ku Japan
                Author notes
                [*] [* ] Correspondence

                Tatsuya Yoshida, Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan.

                Email: tatyoshi@ 123456ncc.go.jp

                Author information
                https://orcid.org/0000-0001-5461-9894
                https://orcid.org/0000-0001-9690-7472
                https://orcid.org/0000-0002-3171-6031
                https://orcid.org/0000-0003-3537-0020
                Article
                CAS14560
                10.1111/cas.14560
                7541013
                32639668
                0ef1de34-45e0-4841-9c78-9d0d9e614de8
                © 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 12 March 2020
                : 02 June 2020
                : 18 June 2020
                Page count
                Figures: 4, Tables: 2, Pages: 9, Words: 6780
                Funding
                Funded by: Boehringer Ingelheim Japan , open-funder-registry 10.13039/100001003;
                Categories
                Original Article
                Clinical Research
                Custom metadata
                2.0
                October 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.2 mode:remove_FC converted:07.10.2020

                Oncology & Radiotherapy
                egfr‐tki,non–small‐cell lung cancer,propensity scoring analysis,real‐world data

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