Long-term oncological safety of sentinel lymph node biopsy in early-stage cervical cancer.

6006 Background: The goal of this study was to assess disease-free survival (DFS) and disease-specific survival (DSS) in patients with early-stage cervical cancer who underwent bilateral sentinel lymph node (BSLN) biopsy alone versus bilateral pelvic lymphadenectomy (BPL). Methods: An ancillary analysis of two prospective multicentric trials on SLN biopsy for cervical cancer (SENTICOL I and II) was performed. All patients with early stage cervical cancer (IA to IIB FIGO stage), negative SLN after ultrastaging and negative non-SLN after final pathologic examination were included. Risk-factors of recurrency and disease-specific deaths were determined by Cox proportional hazard models. Kaplan-Meier survival curves were compared by applying log-rank test. Results: Between January 2005 and July 2012, 259 patients met the inclusion criteria: 85 patients underwent only bilateral SLN biopsy whereas 174 patients underwent BPL. None had positive SLN at ultrastaging or positive non-SLN at final pathologic examination. Between the both groups, there was no differences in histology, final FIGO stage and type of surgical approach. In the BPL group, patients had more frequently tumor size larger than 20 mm (22.9% vs 10.7%, p = 0.02) and postoperative radiochemotherapy (10.7% vs 1.6%, p = 0.01). The median follow-up was 47 months (4-127). During the follow-up, 21 patients (8.1%) experienced reccurencies, including 4 nodal recurrences (1.9%), and 9 patients (3.5%) died of cervical cancer. The 5-year DFS and the DSS were similar between BSLN and BPL groups, 94.1% vs 97.7%, p = 0.14 and 88.2% vs 93.7%, p = 0.14 respectively. After controlling for final FIGO stage and margin status, BSLN compared to BPL was not associated with DFS (HR = 1.76, 95%CI = [0.69 – 4.53], p = 0.24) and DSS (HR = 2.5, 95%CI = [0.64 – 9.83], p = 0.19). Only final FIGO stage was independent predictor of DSS. Conclusions: SLN biopsy alone is oncologically safe in early-stage cervical cancer. Full lymphadenectomy could be omitted in case of bilateral negative SLN. Worse prognosis was associated with higher FIGO stage disease.

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Sentinel Lymph-Node Biopsy in Early-Stage Cervical Cancer: The 4-Year Follow-Up Results of the Senticol 2 Trial

Frontiers in Oncology ◽

10.3389/fonc.2020.621518 ◽

2021 ◽

Vol 10 ◽

Author(s):

Guillaume Favre ◽

Benedetta Guani ◽

Vincent Balaya ◽

Laurent Magaud ◽

Fabrice Lecuru ◽

...

Keyword(s):

Cervical Cancer ◽

Lymph Node ◽

Sentinel Lymph Node ◽

Early Stage ◽

Disease Free Survival ◽

Lymph Node Biopsy ◽

Free Survival ◽

Early Stage Cervical Cancer ◽

Disease Free

IntroductionSenticol 2 is a randomized multicenter trial in the treatment of early-stage cervical cancer patients. The aim of the Senticol 2 study was to compare the effect of sentinel-lymph-node biopsy (SLNB) to that of SLNB + pelvic lymphadenectomy (PLND), and to determine the postoperative lymphatic morbidity in the two groups. Here, we report a secondary objective of this study: the follow up.Material and MethodsIn the Senticol 2 trial, patients underwent a laparoscopy with a sentinel-node-detection procedure and were randomized into two groups, namely: Group A, in which participants received SLNB, and Group B, in which participants received SLNB + PLND. Patients with an intra-operative macroscopically suspicious lymph node, were given a frozen-section evaluation and were randomized only if the results were negative. All of the patients received follow up with a clinical examination at 1, 3, and 6 months after surgery, and then every 3–4 months after that. The median follow up was 51 months (4 years and 3 months).ResultsDisease-free survival after 4 years for the SLNB group and the SLNB + PLND group were 89.51% and 93.1% (p = 0.53), respectively. The only statistical factor associated with recurrence in the univariate analysis was the adjuvant radiotherapy. No other factors, including the age of the patients, histological type, tumor size, lymph vascular space invasion (LVSI), and positive nodal status, were significant in the univariate or multivariate analyses. The overall survival rates after 4 years in the SLNB and SLNB + PLND groups were 95.2% and 96% (p = 0.97), with five and four deaths, respectively. The univariate and multivariate analyses did not find any prognostic factors.ConclusionsThis randomized study confirmed the results of the Senticol 1 study and supports the sentinel lymph node (SLN) technique as a safe technique for use in patients with early-stage cervical cancer treated with SLNB only. Disease-free survival after 4 years was similar in patients treated with SLN biopsy and patients who underwent a lymphadenectomy.

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983 Sentinel lymph-node biopsy in early-stage cervical cancer: the 4-year follow-up results of the senticol 2 trial

10.1136/ijgc-2021-esgo.84 ◽

2021 ◽

Author(s):

G Favre ◽

B Guani ◽

V Balaya ◽

L Magaud ◽

F Lecuru ◽

...

Keyword(s):

Cervical Cancer ◽

Lymph Node ◽

Sentinel Lymph Node ◽

Sentinel Lymph Node Biopsy ◽

Early Stage ◽

Lymph Node Biopsy ◽

Node Biopsy ◽

Early Stage Cervical Cancer

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Can Conization Specimens Predict Sentinel Lymph Node Status in Early-Stage Cervical Cancer? A SENTICOL Group Study

Cancers ◽

10.3390/cancers13215423 ◽

2021 ◽

Vol 13 (21) ◽

pp. 5423

Author(s):

Vincent Balaya ◽

Benedetta Guani ◽

Julie Mereaux ◽

Laurent Magaud ◽

Basile Pache ◽

...

Keyword(s):

Cervical Cancer ◽

Lymph Node ◽

Sentinel Lymph Node ◽

Early Stage ◽

Figo Stage ◽

Lymph Node Involvement ◽

Lymph Node Status ◽

Pathologic Features ◽

Early Stage Cervical Cancer ◽

Node Involvement

Background: The prognosis of patients with cervical cancer is significantly worsened in case of lymph node involvement. The goal of this study was to determine whether pathologic features in conization specimens can predict the sentinel lymph node (SLN) status in early-stage cervical cancer. Methods: An ancillary analysis of two prospective multicentric database on SLN biopsy for cervical cancer (SENTICOL I and II) was carried out. Patients with IA to IB2 2018 FIGO stage, who underwent preoperative conization before SLN biopsy were included. Results: Between January 2005 and July 2012, 161 patients from 25 French centers fulfilled the inclusion criteria. Macrometastases, micrometastases and Isolated tumor cells (ITCs) were found in 4 (2.5%), 6 (3.7%) and 5 (3.1%) patients respectively. Compared to negative SLN patients, patients with micrometastatic and macrometastatic SLN were more likely to have lymphovascular space invasion (LVSI) (60% vs. 29.5%, p = 0.04) and deep stromal invasion (DSI) ≥ 10 mm (50% vs. 17.8%, p = 0.04). Among the 93 patients with DSI < 10 mm and absence of LVSI on conization specimens, three patients (3.2%) had ITCs and only one (1.1%) had micrometastases. Conclusions: Patients with DSI < 10 mm and no LVSI in conization specimens had lower risk of micro- and macrometastatic SLN. In this subpopulation, full node dissection may be questionable in case of SLN unilateral detection.

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

International Journal of Gynecological Cancer ◽

10.1136/ijgc-2020-001857 ◽

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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