Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

Castellano, Isabella; Macrì, Luigia; Deambrogio, Cristina; Balmativola, Davide; Bussone, Riccardo; Ala, Ada; Coluccia, C; Sapino, Anna

doi:10.1097/sla.0b013e31823000ed

Cited by 64 publications

(60 citation statements)

References 43 publications

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“…This is a limitation of such studies, yet there is no way of avoiding it. It would be interesting to perform OSNA examination on the whole lymph node, as is done in breast cancer [45,46]. Unfortunately, since no studies evaluating the accuracy of OSNA in thyroid cancer have been carried out, it is impossible, from an ethical and legal point of view, to perform OSNA instead of histopathology.…”

Section: Prace Oryginalnementioning

confidence: 99%

Badanie metodą jednostopniowej amplifikacji kwasu nukleinowego węzłów chłonnych w raku brodawkowatym tarczycy — porównanie z badaniem histopatologicznym i badaniem PCR w czasie rzeczywistym

Kaczka

Fendler

Borowiec

et al. 2015

Endokrynologia Polska

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First one-step nucleic acid amplification testing in papillary thyroid cancer lymph nodes -a comparison with histopathology and real-time PCRBadanie metodą jednostopniowej amplifikacji kwasu nukleinowego węzłów chłonnych w raku brodawkowatym tarczycy -porównanie z badaniem histopatologicznym i badaniem PCR w czasie rzeczywistym AbstractIntroduction: The significance of lymph node metastases and the optimal extent of lymphadenectomy remain matters of controversy in papillary thyroid cancer. This study was designed to assess the feasibility and reliability of OSNA and real-time PCR for CK19 and TG mRNA in papillary thyroid cancer lymph nodes evaluation compared to standard histopathology. Material and methods: Each of 92 randomised lymph nodes from 32 papillary thyroid cancer patients were divided into representative parts and assessed using the three studied methods. Results: Eighteen (19.6%) lymph nodes from ten (31.3%) patients were positive according to histopathology. When the cut-off value distinguishing metastatic from non-metastatic lymph nodes in the OSNA assay was set at 250 copies per microlitre, the results were positive in 16 (17.4%) lymph nodes from 11 (34.4%) patients. Twenty three (25%) lymph nodes were tested positive in real-time PCR for TG mRNA. Real-time PCR for CK19 mRNA was positive in 18 (19.6%) lymph nodes from 13 (40.6%) patients. No statistically significant differences were noted between the diagnostic accuracy of either molecular method compared to the histopathological examination (p = 0.81). Overall, 20 positive molecular biology results were noted in patients with negative histopathology results. Conversely, in 18 lymph nodes, despite a metastasis finding in histopathology, at least one molecular test yielded a negative result. Conclusions: It was revealed that OSNA is a reliable technique for the evaluation of lymph node metastases in papillary thyroid cancer. This method was shown to have equivalent accuracy to histopathology and real-time PCR. (Endokrynol Pol 2014; 65 (6): 422-430)

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Section: Prace Oryginalnementioning

confidence: 99%

Badanie metodą jednostopniowej amplifikacji kwasu nukleinowego węzłów chłonnych w raku brodawkowatym tarczycy — porównanie z badaniem histopatologicznym i badaniem PCR w czasie rzeczywistym

Kaczka

Fendler

Borowiec

et al. 2015

Endokrynologia Polska

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“…Two 52,59 of the cohort studies reveal reasonably homogeneous patient populations with regard to age and clinical status. A relatively small sample size was used for each patient group in the study reported by Guillen-Paredes, 56 with a difference of ∼7 years for mean age.…”

Section: One-step Nucleic Acid Amplificationmentioning

confidence: 99%

“…Sixteen test accuracy papers were included for OSNA, [50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65] with two papers reporting the same study. Two unpublished papers 40,66 for Metasin were identified and assessed using the Standards for the Reporting of Diagnostic Accuracy Studies (STARD) in Table 7.…”

Section: Number and Description Of Included Studiesmentioning

confidence: 99%

A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer

Huxley

Jones-Hughes

Snowsill

et al. 2015

Health Technology Assessment

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BackgroundIn breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2–4 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (CK19) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using theCK19and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of using OSNA and Metasin in the NHS in England for the intraoperative diagnosis of sentinel lymph nodes metastases, compared with postoperative histopathology, the current standard.Data sourcesElectronic databases including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library and the Health Economic Evaluations Database as well as clinical trial registries, grey literature and conference proceedings were searched up to July 2012.Review methodsA systematic review of the evidence was carried out using standard methods. Single-gate studies were used to estimate the accuracy of OSNA with histopathology as the reference standard. The cost-effectiveness analysis adapted an existing simulation model of the long-term costs and health implications of early breast cancer diagnostic outcomes. The model accounted for the costs of an extended first operation with intraoperative testing, the loss of health-related quality of life (disutility) from waiting for postoperative test results, disutility and costs of a second operation, and long-term costs and disutility from lymphoedema related to ALND, adjuvant therapy, locoregional recurrence and metastatic recurrence.ResultsA total of 724 references were identified in the searches, of which 17 studies assessing test accuracy were included in the review, 15 on OSNA and two on Metasin. Both Metasin studies were unpublished. OSNA sensitivity of 84.5% [95% confidence interval (CI) 74.7% to 91.0%] and specificity of 91.8% (95% CI 87.8% to 94.6%) for patient nodal status were estimated in a meta-analysis of five studies [unadjusted for tissue allocation bias (TAB)]. At these values and a 20% node-positive rate, OSNA resulted in lifetime discounted cost-savings of £498 and a quality-adjusted life-year (QALY) loss of 0.048 relative to histopathology, that is, £4324 saved per QALY lost. The most favourable plausible scenario for OSNA in terms of the node-positive rate (range 10–40%), diagnostic accuracy values (91.3% sensitivity and 94.2% specificity, from three reports that adjusted for TAB), the costs of histopathology, OSNA and second surgery, and long-term costs and utilities resulted in a maximum saving per QALY lost of £10,500; OSNA sensitivity and specificity would need to be ≥ 95% for this figure to be ≥ £20,000.LimitationsThere is limited evidence on the diagnostic test accuracy of intraoperative tests. The quality of information on costs of resource utilisation during the diagnostic pathway is low and no evidence exists on the disutility of waiting for a second surgery. No comparative studies exist that report clinical outcomes of intraoperative diagnostic tests. These knowledge gaps have more influence on the decision than current uncertainty in the performance of postoperative histopathology in standard practice.ConclusionsOne-step nucleic acid amplification is not cost-effective for the intraoperative diagnosis of sentinel lymph node metastases. OSNA is less accurate than histopathology and the consequent loss of health benefits in this patient group is not compensated for by health gains elsewhere in the health system that may be obtained with the cost-savings made. The evidence on Metasin is insufficient to evaluate its cost-effectiveness.Study registrationThis study is registered as PROSPERO CRD42012002889.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Photographic documentation of sampling is extremely helpful in this respect and for accurate evaluation of the status of resection margins (Figure 1). The examination of sentinel lymph node after NAT should be as accurate as possible, but molecular test (such as One Step Nucleic Acid Amplification assay, ie, OSNA (19)) and immunocytochemistry for cytokeratins are not recommended (20).…”

Section: Gross Handling and Reporting Of Surgical Specimens After Natmentioning

confidence: 99%

The Perfect Pathology Report After Neoadjuvant Therapy

et al. 2015

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Neoadjuvant therapy is increasingly being used in the management of breast cancer patients and, since comprehensive specimen handling and precise histological reporting is essential to assess the degree of response to therapy, histopathologists are acknowledged to play a key role in this multidisciplinary setting. However, as a matter of fact, only minimal guidelines for specimen handling are on record. This means that in every day routine practice it is not uncommon for oncologists to deal with pathology reports where important parameters are missing (such as formal comments about therapy response). According to the latest American Joint Committee on Cancer (AJCC) staging classification, posttreatment size of residual disease (ypT) should be estimated based on the best combination of imaging, gross and microscopic histological findings. Therefore, pathologists should ideally be provided with clinical and radiological information before proceeding with careful grossing. During the cut-up, large sections or extensive mapping of samples submitted to microscopic evaluation should be carried out to reconstruct the disease extent: this is particularly crucial when the lesion is unapparent both at imaging and at macroscopic observation. Histopathological reports cannot preclude from mandatory information about the presence of residual invasive carcinoma, such as histotyping, staging (ypTNM), reevaluation of prognostic and predictive factors, and categorization of degree of response according to dedicated classification systems (performed by comparing pretreatment biopsies with surgical specimens). In this review we will analyze the critical issues in such an assessment and we will provide a pragmatic approach with the intent to aim at the "perfect" pathology report.

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Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

Cited by 64 publications

References 43 publications

Badanie metodą jednostopniowej amplifikacji kwasu nukleinowego węzłów chłonnych w raku brodawkowatym tarczycy — porównanie z badaniem histopatologicznym i badaniem PCR w czasie rzeczywistym

Badanie metodą jednostopniowej amplifikacji kwasu nukleinowego węzłów chłonnych w raku brodawkowatym tarczycy — porównanie z badaniem histopatologicznym i badaniem PCR w czasie rzeczywistym

A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer

The Perfect Pathology Report After Neoadjuvant Therapy

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