Role of one-step nucleic acid amplification (OSNA) to detect sentinel lymph node low-volume metastasis in early-stage cervical cancer

2020 ◽  
Vol 30 (3) ◽  
pp. 364-371 ◽  
Author(s):  
Nicolò Bizzarri ◽  
Luigi Pedone Anchora ◽  
Gian Franco Zannoni ◽  
Angela Santoro ◽  
Michele Valente ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Nucleic Acid ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Pelvic Lymphadenectomy ◽  
Nucleic Acid Amplification ◽  
Early Stage Cervical Cancer ◽  
One Step ◽  
Low Volume

IntroductionGrowing evidence in the literature supports the accuracy of sentinel lymph node (SLN) biopsy in early-stage cervical cancer. One-step nucleic acid amplification (OSNA) is a rapid assay able to detect cytokeratin 19-mRNA in SLNs, and it can be used for intra-operative detection of low-volume metastases. The aim of this study was to evaluate the rate of low-volume metastasis in SLNs detected by OSNA in patients with early-stage cervical cancer. Secondary aims were to define the sensitivity and the negative predictive value of SLN biopsy assessed with OSNA.MethodsAfter IRB approval, consecutive patients who underwent surgery for International Federation of Gynecology and Obstetrics stage IA1 with lymph-vascular space involvement to IB1 between November 2017 and July 2019 and had SLN biopsy and pelvic lymphadenectomy were included. SLNs were detected with indocyanine-green cervical injection and sent intra-operatively for OSNA.ResultsEighteen patients underwent SLN assessment with OSNA and systematic pelvic lymphadenectomy in the study period. Four (22.2%) patients had unilateral and 14 (77.8%) had bilateral mapping. OSNA detected micro-metastasis in 6/18 (33.3%) patients. All micro-metastases were detected in patients with bilateral SLN mapping. The sensitivity and negative predictive value of SLN in detecting lymph node metastasis with OSNA calculated per pelvic sidewall were 85.7% and 96.1%, respectively. The false negative rate in mapped sidewalls was 14.3%.DiscussionThis is the first series entirely processing SLNs for OSNA in early-stage cervical cancer. OSNA is able to intra-operatively detect low-volume metastases in SLNs. Further studies are necessary to confirm the accuracy of this technique and to assess survival implications of low-volume metastases detected by OSNA.

Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer

2012 ◽  
Vol 124 (3) ◽  
pp. 496-501 ◽  
Author(s):  
D. Cibula ◽  
N.R. Abu-Rustum ◽  
L. Dusek ◽  
M. Zikán ◽  
A. Zaal ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Prognostic Significance ◽  
Lymph Node Disease ◽  
Node Disease ◽  
Early Stage Cervical Cancer ◽  
Low Volume

scholarly journals One-step nucleic acid amplification (OSNA) of Sentinel Lymph Node in Early Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA).

2021 ◽  
Author(s):  
M. D. Diestro ◽  
A. Berjón ◽  
I. Zapardiel ◽  
L. Yébenes ◽  
I. Ruiz ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Lymph Node ◽  
Nucleic Acid ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Nucleic Acid Amplification ◽  
One Step ◽  
Hematoxylin Eosin ◽  
Early Stage Endometrial Cancer ◽  
Osna Assay

The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study. 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1-mm portion of each lymph node was subjected to semi-serial sectioning at 200-μm intervals and examined by hematoxylin-eosin and immunohistochemistry with CK19; the remaining tissue was analysed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/μl), the sensitivity of the OSNA assay was 92%; specificity was 82%; diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.

A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX)

2019 ◽  
Vol 29 (1) ◽  
pp. 212-215 ◽  
Author(s):  
David Cibula ◽  
J Dusek ◽  
J Jarkovsky ◽  
P Dundr ◽  
D Querleu ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Recurrence Rate ◽  
Early Stage ◽  
Lower Leg ◽  
Multicenter Trial ◽  
Pelvic Lymphadenectomy ◽  
Early Stage Cervical Cancer ◽  
Prospective Multicenter Trial

ObjectiveSentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy.Materials and methodsSENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up.ConclusionsThe first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063).

scholarly journals Detection of sentinel lymph node metastases in cervical cancer: Assessment of KRT19 mRNA in the one-step nucleic acid amplification (OSNA) method

2013 ◽  
Vol 130 (3) ◽  
pp. 530-536 ◽  
Author(s):  
Satoshi Okamoto ◽  
Hitoshi Niikura ◽  
Kadzuki Nakabayashi ◽  
Kayo Hiyama ◽  
Maki Matoda ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Nucleic Acid ◽  
Sentinel Lymph Node ◽  
Lymph Node Metastases ◽  
Nucleic Acid Amplification ◽  
One Step ◽  
Node Metastases ◽  
The One ◽  
Osna Method

scholarly journals One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)

Cancers ◽  
2021 ◽  
Vol 13 (17) ◽  
pp. 4465
Author(s):  
María Dolores Diestro ◽  
Alberto Berjón ◽  
Ignacio Zapardiel ◽  
Laura Yébenes ◽  
Irune Ruiz ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Lymph Node ◽  
Nucleic Acid ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Nucleic Acid Amplification ◽  
One Step ◽  
Hematoxylin Eosin ◽  
Early Stage Endometrial Cancer ◽  
Osna Assay

The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study, and 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1 mm portion of each lymph node was subjected to semi-serial sectioning at 200 μm intervals and examined by hematoxylin–eosin and immunohistochemistry with CK19; the remaining tissue was analyzed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/μL), the sensitivity of the OSNA assay was 92%, specificity was 82%, diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.

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