2016
DOI: 10.1016/j.jtho.2016.03.019
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A Validation Study for the Use of ROS1 Immunohistochemical Staining in Screening for ROS1 Translocations in Lung Cancer

Abstract: IHC staining can be used to screen for ROS1 gene rearrangements, with patients herein showing a response to crizotinib. Patients with tumors that test positive according to IHC staining but negative according to FISH were also identified, which may have implications for treatment selection.

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Cited by 40 publications
(32 citation statements)
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“…Thus, we applied ‘H‐score > 150 and no other genetic alteration’ as the screening criteria of ROS1 IHC and increased the specificity to 81.6%. Compared with previous studies, the specificity of our criteria was relatively lower. This difference may due to the sample size: our sample was larger than that in any previous studies; thus, the number of discordant cases was also greater.…”
Section: Discussioncontrasting
confidence: 90%
See 1 more Smart Citation
“…Thus, we applied ‘H‐score > 150 and no other genetic alteration’ as the screening criteria of ROS1 IHC and increased the specificity to 81.6%. Compared with previous studies, the specificity of our criteria was relatively lower. This difference may due to the sample size: our sample was larger than that in any previous studies; thus, the number of discordant cases was also greater.…”
Section: Discussioncontrasting
confidence: 90%
“…We reviewed the published literature and found that ROS1 protein was expressed frequently in ROS1-non-rearranged cases. We also found and that, in all, 37 ROS1-non-rearranged cases with IHC 2-3 + or high H-scores had been reported to date (Table 4), 10,12,14,15,19,20 posing a challenge for the screening of ROS1-rearranged lung cancer. However, knowledge regarding how to distinguish real ROS1rearranged cases from discordant cases is limited.…”
Section: Discussionsupporting
confidence: 72%
“…Although the recently updated CAP/IASLC/AMP molecular testing guidelines allow the use of ROS1 IHC for screening purposes, there has been only one antibody available to date (D4D6). [9][10][11] The sensitivity for this clone was controversial, probably reflecting the different interpretation criteria and the small numbers that were tested in most studies (reviewed in 9,10,[25][26][27][28] ). The recent release of a new clone (SP384), with only one published report available to date, provides an in vitro diagnostic alternative.…”
Section: Discussionmentioning
confidence: 99%
“…31 Suitable primary antibodies are available and have been extensively validated. [32][33][34][35][36] In our prospectively conducted single-center biomarker screening program we decided to implement a two-step process based on ROS1 IHC analysis prescreening followed by FISH. In our experience (see Supplementary Table 1), we see no correlation between ROS1 expression level at IHC analysis and FISH results.…”
Section: Discussionmentioning
confidence: 99%