Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial

Frumovitz, Michael; Plante, Marie; Lee, Paula S.; Sandadi, Samith; Lilja, James Frederick; Escobar, Pedro F.; Gien, Lilian T.; Urbauer, Diana L.; Abu‐Rustum, Nadeem R.

doi:10.1016/s1470-2045(18)30448-0

Cited by 245 publications

(164 citation statements)

References 31 publications

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“…As recently reported by Frumovitz et al [38], another potential pitfall that could influence the failure of SLN biopsy is the removal of a presumed mapped lymph node that on final pathology is determined to be only lymphatic trunks or adipose tissue without nodal tissue.…”

Section: Discussionmentioning

confidence: 98%

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green

Ianieri

Puppo²,

Novelli³

et al. 2019

Gynecol Obstet Invest

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Background: The sentinel lymph node (SLN) mapping for endometrial cancer staging is gaining wide diffusion, but there is no definitive evidence on the factors associated with the failure of mapping. Objectives: To analyze the factors associated with the possible failure of bilateral SLN mapping with indocyanine green (ICG). Methods: A prospective observational study without control on 110 patients with endometrial cancer apparently confined to the uterus, underwent laparoscopic surgical staging with SLN mapping with ICG. Results: Possible risk factors associated with bilateral mapping failure were analyzed, and a multivariate analysis was performed. The bilateral detection rate for SLNs mapping was 72.7%, whereas at least one SLN was detected in 79.1% of patients. No SLNs were identified in 6.3%. None of the patients or features related to tumor were associated with a risk of failure of the method. The only factor analyzed that was significantly associated with the success of bilateral mapping was the surgeon (p = 0.003). Conclusions: Neither obesity nor the presence of lymph node metastases was associated with mapping failure. However, there remains a need for further studies to understand all the mechanisms linked to the unsuccessful method results and to reduce the use of systematic lymphadenectomy in the case of mapping failure.

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Section: Discussionmentioning

confidence: 98%

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green

Ianieri

Puppo²,

Novelli³

et al. 2019

Gynecol Obstet Invest

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“…Our rate of bilateral mapping was quite similar to this large study with a slightly lower sensitivity of identifying any SLN using methylene blue. Another large trial (FILM) was also recently published comparing ICG to isosulfan blue dye in detecting sentinel lymph nodes in women with cervical and uterine cancers . In this noninferiority, within‐patient comparison study, patients aged 18 years or older with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with Isosulfan blue dye (visualized by white light) followed by indocyanine green (visualized by near‐infrared imaging) or indocyanine green followed by isosulfan blue dye.…”

Section: Discussionmentioning

confidence: 99%

Robotic sentinel node mapping in clinical stage 1 endometrial cancer using methylene blue dyes using the robotic platform

McDonald

Samant

et al. 2019

Robotics Computer Surgery

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Purpose Endometrial cancer is a surgically staged cancer. We examined our preliminary experience with sentinel lymph node (SLN) mapping in early stage endometrial cancer using methylene blue dyes. Method Retrospective review of all clinically stage 1 endometrial cancer staged surgically using the robotic platform. Logistic regression models were built to predict nodal metastasis taking into account age, grade, histology, depth of myometrial invasion, cervical involvement, and use of SLN mapping. Results Four hundred sixty‐nine patients were reviewed. Sixty patients had SLN mapping (13%). Four hundred nine patients underwent standard lymphadenectomy with five documented nodal metastasis (1.2%). Five nodal metastasis (8.3%) were seen in the SLN patients. In the logistic model, the application of SLN mapping was significantly associated with diagnosed nodal metastasis (OR 7.74; 95% CI, 2.04‐29.3; P = .003) together with nonendometroid histology (OR 5.05; 95% CI, 1.27‐20.12; P = .022). Conclusion SLN mapping protocol using methylene blue significantly identifies more nodal metastasis than standard lymphadenectomy.

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“…The recently published FILM (Fluorescence Imaging for Lymphatic Mapping) trial definitively addressed the question of whether ICG was non-inferior to single-agent blue dye 27. The FILM trial was an international, multi-center, randomized, open-label, phase III trial comparing use of ICG and laparoscopic near-infrared imaging to detect SLNs (any or bilateral) as compared with the standard therapy determined to be single-agent blue dye among patients with clinical stage I endometrial cancer.…”

Section: Feasibility Technique Development and Variationmentioning

confidence: 99%

Current state of sentinel lymph nodes for women with endometrial cancer

Rossi

2019

Int J Gynecol Cancer

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Sentinel lymph node (SLN) biopsy has been investigated as an alternative to conventional pelvic and para-aorticlymphadenectomy for the surgical staging of endometrial cancer. Clinical trials have established the accuracy of sentinel nodes in the detecting metastatic disease. Novel advancements in tracers from the historically favored blue dyes and radio labeled colloids to near infrared imaging of fluorescent dyes has improved the ability to detect sentinel nodes and increased options for surgeons. The uterine cervix has been shown to be a feasible and accurate injection site for tracer, though the potential for under-evaluation of the para-aortic nodes remains a controversy, particularly for high-risk cancers. Additionally, sentinel node evaluation provides qualitatively different information than traditional staging techniques by identifying lymph nodes outside of traditional sampling locations and through the identification of very low volume meta static disease implants, such as isolated tumor cells. It is unclear how this altered staging information should be interpreted, guide the prescription of adjuvant therapy and its impact on long term clinical outcomes such as recurrence and survival. In this review we will discuss the evidence that has supported the use of the SLN technique in the staging of endometrial cancer, the options for surgical technique and the implications of managing the results of staging pathology.

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Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial

Abstract: Novadaq.

Cited by 245 publications

References 31 publications

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green

Robotic sentinel node mapping in clinical stage 1 endometrial cancer using methylene blue dyes using the robotic platform

Current state of sentinel lymph nodes for women with endometrial cancer

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