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).

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.

Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010)

2020 ◽  
Vol 30 (11) ◽  
pp. 1829-1833
Author(s):  
Hua Tu ◽  
He Huang ◽  
Bingna Xian ◽  
Jibin Li ◽  
Ping Wang ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Primary Endpoint ◽  
Early Stage ◽  
Frozen Section ◽  
Disease Free Survival ◽  
Pelvic Lymphadenectomy ◽  
Oncological Outcomes ◽  
Early Stage Cervical Cancer

BackgroundThere is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone.Primary ObjectiveTo comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis.Study HypothesisIt is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given.Trial DesignAll eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors.Major Inclusion/Exclusion CriteriaPatients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma.Primary EndpointThe primary endpoint is disease-free survival.Sample SizeEstimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively.Estimated Dates for Completing Accrual and Presenting ResultsAs of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026.Trial RegistrationNCT02642471.

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