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  • 1
    In: Molecular Cancer Therapeutics, American Association for Cancer Research (AACR), Vol. 17, No. 1_Supplement ( 2018-01-01), p. B073-B073
    Abstract: Background: To compare similarities and differences between PD-L1 IHC assays in patients with urothelial cancer (UC), collaborative Russian Society of Clinical Oncology (RUSSCO) and Russian Society of Pathology (RSP) study was conducted. The first results, presented here, describe a rate of PD-L1 IHC expression assessed by each test and evaluate concordance between 3 assays. Methods: 100 UC tumors were stained with PD-L1 IHC assays (clones SP142, 22C3 and SP263) as used in the clinical trials of second-line therapy of atezolizumab (Ventana SP142), pembrolizumab (Dako 22C3), and durvalumab (Ventana SP263). Four trained pathologists certified by Ventana/Roche and Dako/Agilent in interpreting respective assays independently evaluated the percentages of tumor (TC) and tumor-infiltrating immune cells (IC) staining positive at any intensity. Single clinical cut-off for inclusion in this comparative analysis was used: IC ≥5% for SP142, TC+IC/TC ≥10% for 22C3, and TC or IC ≥25% for SP263. Results: Patients were predominantly male (89%), 47/100 (47%) had grade 3 tumors, 45/100 (45%) and 45/100 (45%) had T1 and T2 stages, respectively. 300 IHC slides were scored. The percent of immune cell staining across 3 assays appears to be higher than for tumor cell staining (45% vs. 8% for SP142; 55% vs. 24% for 22C3; 72% vs. 27% for SP263). There were variabilities in immune cell staining for all assays and in tumor cell staining across SP142 and other assays. The percentage of PD-L1-positive patients was comparable with SP142 (9%), 22C3 (11%) and SP263 (7%). Table indicates the number of cases that were concordant with the index assay scoring algorithm, when an alternative cut-off was used to determine the allocation of cases to clinical groups above and below the cut point. Table Assay clone used for slide stainingScoring AlgorithmSP142IC ≥5%22C3TC+IC / TC ≥10%SP263TC or IC ≥25%SP142100/100 (100%)92/100 (92%)95/100 (95%)22C395/100 (95%)100/100 (100%)95/100 (95%)SP26396/100 (96%)95/100 (95%)100/100 (100%) Conclusions: First comparison showed that concordance was more than 90% between SP142, 22C3, and SP263 assays used for evaluation of PD-L1 expression in patients with urothelial carcinoma. Further analysis is required to draw a final conclusion. Citation Format: Larisa Zavalishina, Patritsiya Povilaitite, Yulia Andreeva, A. Petrov, Inna Pugach, Ekaterina Kharitonova, Alexey Rumyantsev, Grigory Raskin, Georgy Frank, Sergei Tjulandin, Ilya Tsimafeyeu. PD-L1 expression in urothelial cancer: first results from RUSSCO-RSP assay comparision study [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2017 Oct 26-30; Philadelphia, PA. Philadelphia (PA): AACR; Mol Cancer Ther 2018;17(1 Suppl):Abstract nr B073.
    Type of Medium: Online Resource
    ISSN: 1535-7163 , 1538-8514
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2018
    detail.hit.zdb_id: 2062135-8
    SSG: 12
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  • 2
    In: Virchows Archiv, Springer Science and Business Media LLC, Vol. 473, No. 6 ( 2018-12), p. 719-724
    Type of Medium: Online Resource
    ISSN: 0945-6317 , 1432-2307
    RVK:
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2018
    detail.hit.zdb_id: 1463276-7
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 6_suppl ( 2018-02-20), p. 489-489
    Abstract: 489 Background: This collaborative Russian Society of Clinical Oncology (RUSSCO) and Russian Society of Pathology (RSP) study assess the extent of concordance between three validated, commercially available PD-L1 IHC assays for UC patients. Methods: Tumors from 100 UC patients were stained with SP142 (Ventana), 22C3 (Dako) and SP263 (Ventana) clones as used in the clinical trials of second-line therapy of atezolizumab, pembrolizumab and durvalumab. Four trained pathologists independently evaluated the percentages of tumor (TC) and tumor infiltrating immune cells (IC) staining positive at any intensity. One test-specific cutoff rule for each assay in this analysis was pre-specified as: IC ≥5% for SP142, TC+IC ≥10% or TC ≥10% for 22C3, and TC ≥25% or IC ≥25% for SP263. Results: 300 IHC slides were scored. Patients were predominantly male (89%) with T1 (45%) and T2 (45%) stages, respectively. The percent of IC staining across 3 assays is shown to be higher than for TC staining (45% vs. 8% for SP142; 55% vs. 24% for 22C3; 72% vs. 27% for SP263). Pearson Correlation Coefficients for IC were: 0.5, 0.69 and 0.85 between SP142/22C3, SP263/22C3 and SP142/SP263, respectively. Pearson Correlation Coefficients for TC were: 0.93, 0.99 and 0.91 for the same pairs. Table indicates the agreement analysis using recommended individual cutoffs for each test. Conclusions: If a patient with UC is classified as negative by one of the three single tests using the corresponding recommended cutoff rule, the patient will be classified as negative by any other test with a high likelihood (91%-100%), and, therefore, repeated testing can be avoided.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 4
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 10, No. 1 ( 2020-03-03)
    Abstract: The goal of the CLOVER study was to perform a pairwise comparison of four tests based on the same patient population with non-small cell lung cancer (NSCLC): three validated PDL1 immunohistochemistry (IHC) assays (Ventana SP142, Ventana SP263, Dako 22C3) and one PCR test. Four hundred seventy-three NSCLC samples were obtained from a biobank and were stained using PDL1 IHC assays. Four trained pathologists independently evaluated the percentage of tumor cells (TC) and immune cells (IC) that stained positive at any intensity. PDL1 transcripts were quantified in 437 patients by a standard Taqman RT-PCR assay using SDHA as a reference gene. A concordance analysis was performed to assess (1) the correlation of TC and IC between different assays and (2) the predictive properties of one test for another. “High” RNA expression was detected in 187 of 437 (43%) patients. The percentage of PDL1-positive cells (≥1%) was higher among the IC than the TC in all IHC three assays. The Pearson correlation coefficients (PCC) for TC were 0.71, 0.87, and 0.75 between 22C3/SP142, 22C3/SP263, and SP263/SP142, respectively. The PCC for IC were 0.45, 0.61, and 0.68 for the same pairs. A low correlation was observed between the PCR test and each of the three IHC assays; however, if a patient tested low/negative by PCR, then they were likely to test negative by any single IHC test with a high probability (92–99%). Among patients who tested positive by PCR, only 9–45% tested positive by IHC assays. There was excellent positive and negative agreement ( 〉 91%) between 22C3 and SP263 staining using the recommended individual cutoffs for first-line treatment. PCR RNA expression analysis is not equivalent to IHC. However, this method may have some potential for the identification of PDL1-negative tumors. 22C3 could be considered as a substitute for SP263 in first-line treatment.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2615211-3
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