Feasibility of Pooled One-Step Nucleic Acid Amplification for Molecular Staging of Pathologically Node-Negative Colon Cancer: A Prospective Multicenter Study

Introduction: Approximately 20% - 30% of histological lymph node-negative patients with colorectal cancer relapse at five years after surgical treatment. This recurrence is likely due to occult nodal disease undetected by standard histopathological practice which has implications in terms of the clinical management of patients.Material and Methods: Lymph nodes were collected from colectomy specimens. A central section from each lymph node was histologically examined following haematoxylin-eosin staining and the remaining tissue was subjected to OSNA - one step nucleic acid amplification analysis.Results: A total of 1046 lymph nodes from 59 pN0 patients were assessed. Of these, 753 lymph nodes were examined by both methods. The median number of lymph nodes assessed with OSNA - one step nucleic acid amplification was 12 (IQR: 7;16). Among pN0 patients, 17 had OSNA - one step nucleic acid amplification-positive lymph nodes, resulting in a positive molecular staging rate of 28.8% (95% CI: 17.8 - 42.1). Among these patients, 12 (70.59%) were molecular-staged as pN1 and 5 (29.41%) were molecular staged as pN2. The tumour burden of lymph nodes assessed with OSNA - one step nucleic acid amplification ranged from 270 to 17 000 cytokeratin 19 mRNA copies/μL. Most of these patients (88.2%) were found to have lymph nodes with micrometastases only (250 - 4999 copies/μL).Discussion: We provide the results from the first study of the use of the OSNA - one step nucleic acid amplification assay in colorectal cancer patients in Portugal. Our results are in-line with other international studies, showing the improvement on patients’ staging by molecular examination of lymph nodes.Conclusion: In our study, 28.8% of patients with histologically negative lymph nodes were found to have metastatic lymph nodes using OSNA - one step nucleic acid molecular assessment. OSNA - one step nucleic acid assay allows a more accurate staging of patients with colorectal cancer and standardizes lymph node assessment.

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Molecular Lymph Node Staging with One-Step Nucleic Acid Amplification and its Prognostic Value for Patients with Colon Cancer: The First Follow-up Study

World Journal of Surgery ◽

10.1007/s00268-020-05949-6 ◽

2021 ◽

Author(s):

Benjamin Weixler ◽

Sofia Teixeira da Cunha ◽

René Warschkow ◽

Nicolas Demartines ◽

Ulrich Güller ◽

...

Keyword(s):

Colon Cancer ◽

Lymph Node ◽

Nucleic Acid ◽

Prognostic Value ◽

Diagnostic Value ◽

Nucleic Acid Amplification ◽

Lymph Node Staging ◽

Cancer Specific Survival ◽

One Step

Abstract Background Molecular lymph node workup with one-step nucleic acid amplification (OSNA) is a validated diagnostic adjunct in breast cancer and also appealing for colon cancer (CC) staging. This study, for the first time, evaluates the prognostic value of OSNA in CC. Patients and methods The retrospective study includes patients with stage I-III CC from three centres. Lymph nodes were investigated with haematoxylin and eosin (H&E) and with OSNA, applying a 250 copies/μL threshold of CK19 mRNA. Diagnostic value of H&E and OSNA was assessed by survival analysis, sensitivity, specificity and time-dependent receiver operating characteristic curves. Results Eighty-seven patients were included [mean follow-up 53.4 months (± 24.9)]. Disease recurrence occurred in 16.1% after 19.8 months (± 12.3). Staging with H&E independently predicted worse cancer-specific survival in multivariate analysis (HR = 10.77, 95% CI 1.07–108.7, p = 0.019) but not OSNA (HR = 3.08, 95% CI 0.26–36.07, p = 0.197). With cancer-specific death or recurrence as gold standard, H&E sensitivity was 46.7% (95% CI 21.3–73.4%) and specificity 84.7% (95% CI 74.3–92.1%). OSNA sensitivity and specificity were 60.0% (95% CI 32.3–83.7%) and 75.0% (95% CI 63.4–84.5%), respectively. Conclusions In patients with CC, OSNA does not add relevant prognostic value to conventional H&E contrasting findings in other cancers. Further studies should assess lower thresholds for OSNA (< 250 copies/μL).

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One-step Nucleic Acid Amplification Can Identify Sentinel Node-negative Breast Cancer Patients With Excellent Prognosis

Anticancer Research ◽

10.21873/anticanres.13261 ◽

2019 ◽

Vol 39 (3) ◽

pp. 1447-1454 ◽

Cited By ~ 1

Author(s):

KENZO SHIMAZU ◽

TOMOHIRO MIYAKE ◽

JUN OKUNO ◽

YASUTO NAOI ◽

TOMONORI TANEI ◽

...

Keyword(s):

Breast Cancer ◽

Nucleic Acid ◽

Sentinel Node ◽

Cancer Patients ◽

Nucleic Acid Amplification ◽

Breast Cancer Patients ◽

Node Negative ◽

Node Negative Breast Cancer ◽

One Step

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Molecular investigation of lymph nodes in colon cancer patients using one‐step nucleic acid amplification (OSNA)

Cancer ◽

10.1002/cncr.27667 ◽

2012 ◽

Vol 118 (24) ◽

pp. 6039-6045 ◽

Cited By ~ 37

Author(s):

Ulrich Güller ◽

Andreas Zettl ◽

Mathias Worni ◽

Igor Langer ◽

Daniela Cabalzar‐Wondberg ◽

...

Keyword(s):

Colon Cancer ◽

Nucleic Acid ◽

Lymph Nodes ◽

Cancer Patients ◽

Nucleic Acid Amplification ◽

Molecular Investigation ◽

One Step

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One Step Nucleic Acid Amplification (OSNA) - ein standardisiertes Verfahren zur intraoperativen Sentineldiagnostik beim Mammakarzinom

Senologie - Zeitschrift für Mammadiagnostik und -therapie ◽

10.1055/s-0032-1313385 ◽

2012 ◽

Vol 9 (02) ◽

Author(s):

G Broinger

Keyword(s):

Nucleic Acid ◽

Nucleic Acid Amplification ◽

One Step

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Evaluation of Accuracy of One-Step Nucleic Acid Amplification (OSNA) in Diagnosis of Lymph Node Metastases of Papillary Thyroid Carcinoma

Case Medical Research ◽

10.31525/ct1-nct03889769 ◽

2019 ◽

Author(s):

Keyword(s):

Lymph Node ◽

Nucleic Acid ◽

Papillary Thyroid Carcinoma ◽

Thyroid Carcinoma ◽

Lymph Node Metastases ◽

Nucleic Acid Amplification ◽

Papillary Thyroid ◽

One Step ◽

Node Metastases

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Ultrastaging Using Ex Vivo Sentinel Lymph Node Mapping and One-Step Nucleic Acid Amplification (OSNA) in Gastric Cancer: Experiences of a European Center

Cancers ◽

10.3390/cancers13112683 ◽

2021 ◽

Vol 13 (11) ◽

pp. 2683

Author(s):

Bruno Märkl ◽

Bianca Grosser ◽

Kerstin Bauer ◽

Dmytro Vlasenko ◽

Gerhard Schenkirsch ◽

...

Keyword(s):

Nucleic Acid ◽

Detection Rate ◽

Ex Vivo ◽

Sentinel Lymph Node Mapping ◽

Nucleic Acid Amplification ◽

Lymph Node Mapping ◽

Single Positive ◽

Conventional Histology ◽

One Step ◽

Sensitivity Specificity

Background: In this study, the effectiveness of One-step nucleic acid amplification (OSNA) in combination with ex vivo SLN mapping is compared with conventional histology including immunohistochemistry. Methods: LNs were retrieved from gastrectomy specimens in an unfixed state. After ex vivo SLN mapping using methylene-blue, LNs were sliced to provide samples for histology and OSNA. Results: In total, 334 LNs were retrieved in the fresh state from 41 patients. SLN detection was intended in 40 cases but was successful in only 29, with a correct LN status prediction in 23 cases (79%). Excluding one case out of 41 with a failure likely caused by a processing error, OSNA showed a high effectiveness with sensitivity, specificity, and accuracy rates of 85.4%, 93.5%, and 92.4%, respectively. The LN status could be predicted in all but one case, in which the single positive LN was not eligible for OSNA testing. Moreover, OSNA evaluation led to upstaging from N0 to N+ in three cases (14%). Conclusion: The ex vivo SLN protocol used resulted in a relatively poor detection rate. However, the OSNA method was not hampered by this detection rate and proved its potential to increase the sensitivity of metastases detection.

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