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Komiya et al. J Cancer Metastasis Treat 2020;6:4                    Journal of Cancer
               DOI: 10.20517/2394-4722.2019.41                           Metastasis and Treatment




               Original Article                                                              Open Access


               Brain metastasis as exclusion criteria in extensive-
               stage small cell lung cancer trials: a trend over

               decades


               Takefumi Komiya , Gerard Chaaya , Leigh Deshotels , Emily Powell , Achuta Kumar Guddati
                                                            3
                                            2
                              1
                                                                                              5
                                                                         4
               1 Medical Oncology, Parkview Cancer Institute, Fort Wayne, IN 46845, USA.
               2 Section of Hematology/Medical Oncology, Tulane University School of Medicine, New Orleans, LA 70112, USA.
               3 Department of Internal Medicine, Tulane University School of Medicine, New Orleans, LA 70112, USA.
               4 Parkview Research Center, Mirro Center for Research and Innovation, Fort Wayne, IN 46845, USA.
               5 Medical Oncology, Augusta University, Augusta, GA 30901, USA.
               Correspondence to: Dr. Takefumi Komiya, Medical Oncology, Parkview Cancer Institute, 11050 Parkview Circle, Fort Wayne, IN
               46845, USA. E-mail: takefumi.komiya@parkview.com
               How to cite this article: Komiya T, Chaaya G, Deshotels L, Powell E, Guddati AK. Brain metastasis as exclusion criteria in
               extensive-stage small cell lung cancer trials: a trend over decades. J Cancer Metastasis Treat 2020;6:4.
               http://dx.doi.org/10.20517/2394-4722.2019.41
               Received: 18 Nov 2019    First Decision: 7 Jan 2020    Revised: 17 Feb 2020    Accepted: 17 Feb 2020    Published: 21 Feb 2020

               Science Editor: Stephen J. Ralph    Copy Editor: Jing-Wen Zhang    Production Editor: Jing Yu



               Abstract
               Aim: To investigate the frequencies and trends of brain metastases (BMs) as exclusion criteria in extensive-stage
               small cell lung cancer (ES-SCLC) trials.

               Methods: We conducted a comprehensive search to identify prospective clinical trials in patients with ES-SCLC.
               PubMed searches were conducted with the key words “small cell lung cancer” and “extensive”. The online archives
               of 20 oncology journals were also searched. Recent review articles in ES-SCLC were also investigated for additional
               articles. Eligible studies must have enrolled primarily ES-SCLC and been published in English. Studies involving
               brain/chest radiation and brain metastasis-specific trials were excluded. Studies were categorized into allowed/
               undefined, conditional, or complete exclusion of BM.

               Results: In total, 491 published studies were identified by PubMed (240), journal websites (198), and review articles
               (53). Early publication year (1970-1999) and first-line/maintenance setting were associated with higher incidence
               of complete exclusion of cases with BMs (P < 0.0001 and 0.0233, respectively). Incidence of complete exclusion
               was 27% in the 1990s, and then decreased to 12% in the 2000s and 8% in the 2010s.



                           © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0
                           International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,
                sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long
                as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license,
                and indicate if changes were made.


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