Is it time for one-step nucleic acid amplification (OSNA) in colorectal cancer? A systematic review and meta-analysis

Wild, John Benjamin; Iqbal, Nayyer; Francombe, James; Papettas, T.; Sanders, DS; Ramcharan, S

doi:10.1007/s10151-017-1690-0

Cited by 17 publications

(24 citation statements)

References 32 publications

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“…Recently, Miyake et al [27] demonstrated that the ex vivo analysis of perirectal LNs by OSNA predicts LLN metastasis in advanced rectal cancer with a sensitivity of 100%, specificity of 86%, PPV of 57% and NPV of 100%. Other studies and a meta-analysis have also confirmed the ability of the OSNA to predict LN involvement [28]. In our study, OSNA was superior to H&E in identifying LN metastases, with a false negative rate of 0% vs. 44.4% and accuracy of 100% vs. 76.4%, respectively.…”

Section: Discussionsupporting

confidence: 83%

Sentinel Lymph Node Analysis in Colorectal Cancer Patients Using One-Step Nucleic Acid Amplification in Combination With Fluorescence and Indocyanine Green

et al. 2019

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Purpose Analysis of the sentinel lymph node (SLN) in colorectal cancer (CRC) patients was proposed for more accurate staging and tailored lymphadenectomy. The aim of this study was to assess the ability to predict lymph node (LN) involvement through analysis of the SLN with a one-step nucleic acid (OSNA) technique in combination with peritumoral injection of indocyanine green (ICG) and near-infrared (NIR) lymphangiography in CRC patients. Methods A total of 34 patients were enrolled. Overall, 51 LNs were analyzed with OSNA. LNs of 17 patients (50%) were examined simultaneously with hematoxylin and eosin (H&E) and OSNA. Results SLN analysis of 17 patients examined with H&E and OSNA revealed that OSNA had a higher sensitivity (1 vs. 0.55), higher negative predictive value (1 vs. 0.66) and higher accuracy (100% vs. 76.4%) in predicting LN involvement. Overall, OSNA showed a sensitivity of 0.69, specificity of 1, accuracy of 88.2%, and stage migration of 8.8%. Compared to those who were OSNA (−), OSNA (+) patients had a greater number of LN metastases (4.8 vs. 0.16, P = 0.04), higher G3 rate (44.4% vs. 4%, P = 0.01), more advanced stage of disease (stage III: 77.8% vs. 16%; P = 0.00) and were more rapidly subjected to adjuvant chemotherapy (39.1 days vs. 50.2 days, P = 0.01). Conclusion SLN analysis with OSNA in combination with ICG-NIR lymphangiography is feasible and can detect LN involvement in CRC patients. Furthermore, it allows for more accurate staging reducing the delay between surgery and adjuvant chemotherapy.

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Section: Discussionsupporting

confidence: 83%

Sentinel Lymph Node Analysis in Colorectal Cancer Patients Using One-Step Nucleic Acid Amplification in Combination With Fluorescence and Indocyanine Green

et al. 2019

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“…Recently Wild et al 31 performed a systematic review and meta-analysis of OSNA use in CRC and concluded that long-term outcomes and the value of adjuvant therapy in those upstaged by OSNA should be clarified before routine use of OSNA test. In this regard, our study may be constructive because it firstly showed significantly worse 3-year DFS in OSNA-positive pStage II group.…”

Section: Discussionmentioning

confidence: 99%

Lymph Node Positivity in One-Step Nucleic Acid Amplification is a Prognostic Factor for Postoperative Cancer Recurrence in Patients with Stage II Colorectal Cancer: A Prospective, Multicenter Study

et al. 2019

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Background. For colorectal cancer (CRC) patients, the standard histological lymph node (LN) evaluation has low sensitivity. Our previously developed one-step nucleic acid amplification (OSNA TM) assay measures cytokeratin 19 gene expression in whole LNs. We recently showed that 17.6% of pN0 stage II CRC patients were OSNA positive, suggesting a correlation between OSNA results and disease recurrence. This multicenter, prospective study investigateed the prognostic value of the OSNA assay for pStage II CRC patients. Methods. We examined 204 CRC patients who were preoperatively diagnosed as cN0 and cN1 and surgically treated at 11 medical institutions across Japan. Nine patients were excluded, and 195 patients (Stage I: n = 50, Stage II: n = 70, Stage III: n = 75) were examined. All LNs, harvested from patients, were examined histopathologically using one-slice hematoxylin-eosin staining. Furthermore, half of the LNs was examined by the OSNA assay. Patients were classified according to the UICC staging criteria and OSNA results, and the 3-year, diseasefree survival (DFS) of each cohort was analyzed.

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“…Pathological LN staging is considered the gold standard (GS), based on the evaluation of routine haemotoxylin and eosin (H&E)-stained slides; however, evidence indicates that it is not the best methodology of LN staging [10–13]. Significant limitations of this technique are its low sensitivity, since only a small part of the LN is examined [10, 14–18], and the fact that it is a morphology-based analysis [19]. The American Joint Committee on Cancer established that at least 12 LNs should be analysed to assure a reliable pathologic pN0 assessment [20].…”

Section: Introductionmentioning

confidence: 99%

“…The American Joint Committee on Cancer established that at least 12 LNs should be analysed to assure a reliable pathologic pN0 assessment [20]. Therefore, undetected metastases within the unsampled material may be the cause of an increased risk of local recurrence and/or distant metastases after curative-intent surgery [19]. Yamamoto et al reported that 6 of 83 OSNA-positive LNs were diagnosed as negative by H&E and immunohistochemical staining (7.2%) [9].…”

Section: Introductionmentioning

confidence: 99%

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Budget Impact Analysis of Molecular Lymph Node Staging Versus Conventional Histopathology Staging in Colorectal Carcinoma

Diaz‐Mercedes

Archilla

Camps

et al. 2019

Appl Health Econ Health Policy

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BackgroundThe presence of lymph node (LN) metastasis is a critical prognostic factor in colorectal cancer (CRC) patients and is also an indicator for adjuvant chemotherapy. The gold standard (GS) technique for LN diagnosis and staging is based on the analysis of haematoxylin and eosin (H&E)-stained slides, but its sensitivity is low. As a result, patients may not be properly diagnosed and some may have local recurrence or distant metastases after curative-intent surgery. Many of these diagnostic and treatment problems could be avoided if the one-step nucleic acid amplification assay (OSNA) was used rather than the GS technique. OSNA is a fast, automated, standardised, highly sensitive, quantitative technique for detecting LN metastases.ObjectivesThe aim of this study was to assess the budget impact of introducing OSNA LN analysis in early-stage CRC patients in the Spanish National Health System (NHS).MethodsA budget impact analysis comparing two scenarios (GS vs. OSNA) was developed within the Spanish NHS framework over a 3-year time frame (2017–2019). The patient population consisted of newly diagnosed CRC patients undergoing surgical treatment, and the following costs were included: initial surgery, pathological diagnosis, staging, follow-up expenses, systemic treatment and surgery after recurrence. One- and two-way sensitivity analyses were performed.ResultsUsing OSNA instead of the GS would have saved €1,509,182, €6,854,501 and €10,814,082 during the first, second and third years of the analysis, respectively, because patients incur additional costs in later years, leading to savings of more than €19 million for the NHS over the 3-year time horizon.ConclusionsIntroducing OSNA in CRC LN analysis may represent not only an economic benefit for the NHS but also a clinical benefit for CRC patients since a more accurate staging could be performed, thus avoiding unnecessary treatments.Electronic supplementary materialThe online version of this article (10.1007/s40258-019-00482-7) contains supplementary material, which is available to authorized users.

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Is it time for one-step nucleic acid amplification (OSNA) in colorectal cancer? A systematic review and meta-analysis

Abstract: OSNA is as good as routine HE. It may avoid TAB and offer a more objective and standardised assay of LNM. However, for upstaging, its usefulness as an adjunct to HE or superiority to HE requires further assessment of the benefits, if any, of adjuvant therapy in patients upstaged by OSNA.

Cited by 17 publications

References 32 publications

Sentinel Lymph Node Analysis in Colorectal Cancer Patients Using One-Step Nucleic Acid Amplification in Combination With Fluorescence and Indocyanine Green

Sentinel Lymph Node Analysis in Colorectal Cancer Patients Using One-Step Nucleic Acid Amplification in Combination With Fluorescence and Indocyanine Green

Lymph Node Positivity in One-Step Nucleic Acid Amplification is a Prognostic Factor for Postoperative Cancer Recurrence in Patients with Stage II Colorectal Cancer: A Prospective, Multicenter Study

Budget Impact Analysis of Molecular Lymph Node Staging Versus Conventional Histopathology Staging in Colorectal Carcinoma

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