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Sentinel-Lymph-Node (SLN) in Cervical Cancer (Cx Ca). Ami Fishman. SLN detection have been applied to almost every solid tumor. Primary site. SLN status have become part of the American Joint Commission on Cancer (AJCC) staging criteria in:. Breast Ca. Cutaneous Melanoma.
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Sentinel-Lymph-Node (SLN)in Cervical Cancer (Cx Ca) Ami Fishman
SLN detection have been applied to almost every solid tumor Primary site
SLN status have become part of the American Joint Commission on Cancer (AJCC) staging criteria in: Breast Ca Cutaneous Melanoma
Cx Ca is a good candidate for lymphatic mapping Why? 1…. 2…. 3…. 4…. 5….
Cx Ca is a good candidate for lymphatic mapping Why? 1. LN mets is the most important prognostic factor
Cx Ca is a good candidate for lymphatic mapping Why? 2. Incidence of LN+ in stage IB1 (most favorable group) is ~15% this means that: • these pts derive no benefit from LN-ectomy • yet must endure the associated increase in: • operative time • blood loss • risk of lymphocyst • lymphedema
Cx Ca is a good candidate for lymphatic mapping Why? 3. The cervix is a midline structure with complex lymphatic drainage This means that: an extensive pelvic dissection is necessary to be certain that all regional LN are removed
Cx Ca is a good candidate for lymphatic mapping Why? 4. The location of LN+ cannot be determined on the basis of clinical factors of the primary tumor such as: - size - morphology (exophytic vs endophytic) - location (ectoCx vs endoCx)
Cx Ca is a good candidate for lymphatic mapping Why? 5.Accurate determination of LN status would allow triage of LN+ pts to chemo-radiation without radical pelvic surgery aborted
אמירות מוכרות לכם ? "... יש מאמר שמראה ש ..." "... הפרוטוקול המחלקתי אצלנו הוא ..." "... לפי ה– ACOG היה צריך ל..." "..מהניסיון שלי .." "... האם מה שאמרת זה evidence-based "... עשיתי / ראיתי / היו לי כבר הרבה כאלה... "
"... יש מאמר שמראה ש ..." להקפיד על איכות הראיות Quality of Evidence
Filtered information Systematic reviews "... יש מאמר שמראה ש ..." Cohort study Unfiltered information Case–Control study
EBM: Classification of Evidence U.S. Preventive Services Task Force Level I Evidence ממחקר אחד לפחות מסוג RCT Level II-1 Evidence ממחקר מבוקר מתוכנן היטב ללא רנדומיזציה Level II-2 Evidence ממחקר עוקבה או מחקר מקרה-ביקורת מתוכנן היטב, עם עדיפות למחקרים רב-מרכזיים או ממספר קבוצות מחקר Level II-3 Evidence מדיווחים חוזרים של סדרות מקרים עם או בלי ההתערבות מידע על תוצאות דרמטיות ממחקרים לא מבוקרים גם משתייכים לקטגוריה הזו Level III דעות של מומחים שמבוססות על ניסיון אישי, תיאורי מקרים או דיווחים של ועדות מומחים להקפיד על איכות הראיות Quality of Evidence
EBM: Classification of Evidence U.S. Preventive Services Task Force Memorial Sloan-Kattering MD Anderson
Lymphatic mapping & SLN detection in women with CxCa Frumovitz M et al, Gyn Onc 2008 (MD Anderson) (EBM Level II-3) MD Anderson
Lymphatic mapping & SLN detection in women with CxCa Frumovitz M et al, Gyn Onc 2008 (MD Anderson) (EBM Level II-3) Review of the literature n=831 women who underwent lymphatic mapping and SLN detection as part of their Cx Ca Rx Results: SLN was identified = 90% of cases sensitivity for metastatic disease = 92% FN rate = 8% NPV = > 97%
SLN biopsy in the management of early-stage Cx Ca Diaz JP et al, Gyn Onc 2011 (Memorial Sloan-Kattering) (EBM Level II-2) Memorial Sloan-Kattering
SLN biopsy in the management of early-stage Cx Ca Diaz JP et al, Gyn Onc 2011 (Memorial Sloan-Kattering) (EBM Level II-2) Prospective, non-randomized study n=81 Early-stage (Ia1 with LVS+ --> IIA) • SLN mapping was successful = 95% of pts • Median SLN per patient = 3 (range=0-10) • Majority (85%) of SLN were located at 3 main sites: ext. iliac (35%) int. iliac (30%) obturator (20%) Pathologic assessment: • SLN metastasis detected on routine processing in 71% • SLN metastasis detected on ultra-staging in additional 29%
SLN biopsy in the management of early-stage Cx Ca Diaz JP et al, Gyn Onc 2011 (Memorial Sloan-Kattering) (EBM Level II-2) Results (cont): The FN cases occurred during each surgeon's initial SLN mapping learning phase
Multicenter validation study of the SLN concept in CxCa Altgassen et al, J Clin Oncol 2008 (European - AGO Study Group) (EBM level II-2) AGO Study Group
Multicenter validation study of the SLN concept in CxCa Altgassen et al, J Clin Oncol 2008 (European - AGO Study Group) (EBM level II-2) Prospective, multicenter cohort study n=590 Detection rate of pelvic SLN = 88.6% Conclusion: In all stages, sensitivity of the SLN concept was low However, pts with tumor diameter </= 20mm may profit from this concept
סיכום הספרות Detection: Pathology assessment: Surgeon’s / Center's experience:
סיכום הספרות Detection: • SLN mapping in early-stage Cx Ca yields high detection rates • SLN biopsy was reliable only if at least one SLN was identified in each hemi-pelvis • SLN detection rate was significantly higher when both tracers were used versus either tracer alone (combined: 94%; 99mTc: 82%; blue dye: 82%) • If no SLN was detected in any one hemi-pelvis, then a complete pelvic LND should be performed on that side
סיכום הספרות Pathology assessment: • Ultra-staging improves micro-metastasis detection • Surgeon’s / Center's experience: • As with any new technique, success with the SLN procedure is probably affected by a learning curve • Studies with this technique in other cancers suggest 20-30 cases per center as a minimum before outcomes can begin to be evaluated
סיכום הספרות Is the current standard of Cx Ca staging is SLN biopsy ? Vicus & Covens, 2009 (Toronto) In our view the gold standard of LN assessment in early stage Cx Ca has shifted and SLN biopsy has taken the place of a complete LN-ectomy Hertel, Int J Gyn Cancer 2010 (Medical School Hannover) • SLN is currently not a routine procedure for Cx Ca staging • This procedure should be performed only by specialized centers in a study setting • More data on its oncological safety are needed
SLN: a novel staging technique that requires a dedicated effort by a multi-disciplinary team (surgeons, nuclear medicine & pathology) סיפא: השקפה אישית Careful patient selection is essential in order to include only those who may truly benefit from the procedure As with any new technique, accumulation of experience is required before its accuracy can be evaluated