Dataset Information

Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024).

ABSTRACT:

Background

Standard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is no longer necessary for patients who have a negative SLN or micrometastasis (≤2 mm). When there is macrometastasis (>2 mm) in the SLN, an inguinofemoral lymphadenectomy is indicated; however, this procedure is associated with major morbidity, such as wound healing, lymphoceles, and lymphedema.

Primary objective

To investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in patients with early-stage vulvar cancer with a macrometastasis (>2 mm) and/or extracapsular extension in the sentinel node.

Study hypothesis

Combination of 56 Gy of radiation to the inguinal site and concurrent cisplatin chemotherapy without completion inguinofemoral lymphadenectomy will be feasible and safe, with low groin recurrence rates.

Trial design

This is a single-arm, prospective phase II treatment trial with stopping rules for unacceptable groin recurrences. Eligible patients will receive 56 Gy of radiation to the involved inguinal site and chemotherapy with concurrent cisplatin.

Major inclusion/exclusion criteria

Eligible patients undergoing sentinel node procedure will have stage I, unifocal, invasive (>1 mm depth of invasion) squamous cell carcinoma of the vulva with tumor size <4 cm, and no suspicious nodes on imaging. Those eligible for the trial are those with a metastasis >2 mm in the sentinel node and/or extracapsular extension, or more than one sentinel node with micrometastasis ≤2 mm.

Primary endpoint

Groin recurrence rate in the first 2 years after primary treatment.

Sample size

157 patients with macrometastases in their SLN.

Estimated dates for completing accrual and presenting results

January 1, 2029.

Trial registration number

NCT05076942.

SUBMITTER: Gien LT

PROVIDER: S-EPMC10233466 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024).

Gien Lilian T LT Slomovitz Brian B Van der Zee Ate A Oonk Maaike M

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 20230403 4

<h4>Background</h4>Standard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is no longer necessary for patients who have a negative SLN or micrometastasis (<u>≤</u>2 mm). When there is macrometastasis (>2 mm) in the SLN, an inguinofemoral lymphadenectomy is indicated; however, this procedure is associated with major morbidity, such as wound healing, lymphocel ...[more]

PMID: 36653060

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Project description:BackgroundThe safety and benefit of sentinel lymph node biopsy (SLNB) compared with regional lymph node dissection (RLND) and no lymph nodes removed (NA) in patients with vulvar squamous cell cancer (VSCC) was not well studied.MethodsA retrospective analysis on VSCC patients without distant metastasis and adjacent organ invasion from the Surveillance, Epidemiology, and End Results Program database between 2004 and 2016 was carried out. Within subgroups stratified by negative (LN-) or positive (LN+) regional lymph node findings, inverse probability weighting (IPW) adjusted multivariate Fine-Gray compete risk (CR) model and accelerated failure time (AFT) model was used to investigate the factors associated with and cancer-specific survival (CSS) and overall survival (OS).ResultsOf the 3,161 VSCC patients treated with surgery, 287 (9.1%) underwent SLNB, 1,716 (54.3%) underwent RLND, and 1,158 (36.6%) had no regional lymph nodes removed. As illustrated by IPW adjusted multivariate regressions, SLNB was significantly associated with prolonged CSS (LN-, adjusted sub-proportional hazard ratio [sHR] = 0.42; 95% confidence interval [CI], 0.19-0.93; P=0.032; LN+, adjusted sHR = 0.29; 95% CI, 0.16-0.54, P<0.001) and OS (LN-, adjusted time ratio [TR] = 1.38; 95% CI, 0.82-2.32; P=0.226; LN+, adjusted TR = 2.68; 95% CI, 1.73-4.14; P<0.001), although the effect of SLNB on OS was not significant within the LN- cohort. Moreover, SLNB led to improved CSS (adjusted sHR = 0.40; 95% CI, 0.23-0.70; P = 0.001) and OS (adjusted TR=1.15, 95% CI 0.76-1.73, P=0.279) compared with NA. Age was a significant prognostic factor of CSS and OS, whereas tumor size, surgery type, and invasion depth were not.ConclusionsSLNB leads to significantly prolonged CSS and OS in VSCC surgery patients without distant metastasis and adjacent organ invasion than RLND, except for the similar OS in the LN- cohort. SLNB could be carried out preferentially for VSCC surgery patients without distant metastasis and adjacent organ invasion, irrespective of tumor size, surgery type, invasion depth, and regional lymph nodes metastasis. Further prospective clinical trials are warranted to confirm the findings of this study.

Project description:BackgroundAxillary surgical management in patients with node-positive breast cancer at the time of diagnosis converted to negative nodes through neoadjuvant chemotherapy (NAC) remains unclear. Removal of more than two sentinel nodes (SLNs) in these patients may decrease the false negative rate (FNR) of sentinel lymph node biopsies (SLNBs). We aim to analyse the detection rate (DR) and the FNR of SLNB assessment according to the number of SLNs removed.MethodsA retrospective study was performed from October 2012 to December 2018. Patients with invasive breast cancer who had a clinically node-positive disease at diagnosis and with a complete axillary response after neoadjuvant chemotherapy were selected. Patients included underwent SLNB and axillary lymph node dissection (ALND) after NAC. The SLN was considered positive if any residual disease was detected. Descriptive statistics were used to describe the clinicopathologic features and the results of SLNB and ALND. The DR of SLNB was defined as the number of patients with successful identification of SLN. Presence of residual disease in ALND and negative SLN was considered false negative.ResultsA total of 368 patients with invasive breast cancer who underwent surgery after complete NAC were studied. Of them, 85 patients met the eligibility criteria and were enrolled in the study. The mean age at diagnosis was 50.8 years. Systematic lymphadenectomy was performed in all patients, with an average of 10 lymph nodes removed. The DR of SLNB was 92.9%, and the FNR was 19.1. The median number of SLNs removed was 3, and at least, three SLNs were obtained in 42 patients (53.2%). When at least three sentinel nodes were removed, the FNR decreased to 8.7%.ConclusionsIn this cohort, the SLN assessment was associated with an adequate DR and a high FNR. Removing three or more SLNs decreased the FNR from 19.1% to 8.7%. Complementary approaches may be considered for axillary lymph node staging after neoadjuvant chemotherapy. The study was approved by our institution's ethics committee (Instituto de Investigacion Sanitaria Hospital 12 de Octubre (imas12), Universidad Complutense de Madrid, Madrid, Spain) (https://clinicaltrials.gov/ct2/show/NCEI:20/0048).

Dataset Information

Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024).

Background

Primary objective

Study hypothesis

Trial design

Major inclusion/exclusion criteria

Primary endpoint

Sample size

Estimated dates for completing accrual and presenting results

Trial registration number

Publications

Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024).

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