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ESGO 1-st Basic Course in Gynecological Oncology

ESGO 1-st Basic Course in Gynecological Oncology. Yerevan, State Medical University 30 th September - 1 st October 2010. The role of the Lymphadenectomy in Endometrial Cancer. P. Zola Prof. Paolo Zola Department of Gynecologic Oncology University of Turin

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ESGO 1-st Basic Course in Gynecological Oncology

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  1. ESGO 1-st Basic Course in Gynecological Oncology Yerevan, State Medical University 30thSeptember - 1st October 2010 The role of the Lymphadenectomy in Endometrial Cancer P. Zola Prof. Paolo Zola DepartmentofGynecologicOncology UniversityofTurin Mauriziano “ Umberto I ” Hospital

  2. International Federation ofGynecologic and Obstetrics (FIGO) 1978 1988 Clinical Staging System Operative Staging System a paradigm shift inaccurate GOG Study* Stage migration in 22% (144/621) of clinical stage I patients after surgical staging No definite guideline: Type & Extent of LN assessment *Creasman - Morrow et al, Cancer 1987

  3. FIGO STAGING 2009

  4. Surgical Staging: Lymphadenectomy Practices around the world NORTH AMERICA NORTH AMERICA WESTERN EUROPE NETHERLANDS SLOVACK REPUBLIC JPAPAN Partride, ‘99 Roland, ‘04 Maggino, ‘95 Creutzberg, ‘00 Uharcek, ‘06 Konno, ‘00

  5. Perform it or not perform it? What’s new in Literature…

  6. SURVIVAL BENEFITS REMOVING NODAL METASTASES AUTHOR No. PTS INCLUSION OUTCOME EXENT OF BENEFIT (year) CRITERIA BENEFIT FROM CHAN 1221StagesIIIc-IV More extensivelymphadenectomy 5-yrs improvedwithextent 2006 (1, 2-5, 6-10, 11-20, > 20 nodes)ofsurgery - p <0.01 (51, 53, 53, 69, 72%) BRISTOW 38Stage IIIcComplete resectionofbulkynodes 5-yrs DS 2003Extensivesurgery vs macroscopicresidualnodes40% vs 0% - p= 0.006 CORN 50PosAorticNodesSurgicalresection & RT 5-yrs OS 1992 Pathology & vs RT alone 61 vs 33% Lymphography HAVRILESKY 96Stage IIIC Removalofgrossnodaldisease5-yrs DSS 2005 ExtensivesurgeryHR= 6.85 - p=0.009 (Grossnodesnotdebulked) MARIANI137  RiskforAorticPos N Para-aorticlymphadenectomy 5-yrs PFS 2000 Invasion > 50% ( 5 Nodes) 62 vs 77% - p= 0.12 PalpablePosPelvic N 5-yrs OS PosAdnexae71 vs 85% - p= 0.06 51 Positive NodesPara-aorticLymphadenctomy 5-yrs PFS (Pelvic or Aortic) ( 5 Nodes) 36 vs 76% - p= 0.02 5-yrs OS 42 vs 77% - p= 0.05

  7. GOG33 GRADE 2-3, MYOMETRIAL INVASION & NODE 621pts/70 pts N+ (11%); 36(51%)P only, 22(31%) P&PA, 12(17%)PA 58/70 (83%) P pos 34/70 (49%) PA pos Morrow’s rule PELVIC NODE METASTASES ASSESSMENT: GRADE x MYOMETRIAL INVASION x 3= % POSITIVE NODE AORTIC NODE METASTASES ASSESSMENT: GRADE x MYOMETRIAL INVASION x 2= % POSITIVE NODE

  8. Typeoftranslation • Who do notconsiderthatsurgicalstagingis appropriate or necessaryforanypts(GOG33) • Strong proponentsofsurgicalstagingargueforsurgicalstaging in allptsregardlessof the implicationsforptsoutcomes (PFS,OS, L.C.,complication, choiceofsubsequenttherapy) • Only high riskgroupaccordingP.F.

  9. AlgorithmsDecision-Making 1 N+: 0-7% Any G no inv.,G1-2<50% Thomas & Aalders 2007

  10. AlgorithmsDecision-Making 1 In practice: 75% at l.risk are not staged nor adj therapy 25% at h.risk received Rt (!) Thomas & Aalders 2007

  11. MINIMUN BENEFIT LYMPHEDENECTOMY IN LOW RISK AUTHOR No. PTS INCLUSION CRITERIA OUTCOME MARIANI 328G1-2 EndometrioidOveralldisease-specificsurvival 97% 2000 Invasion <50% (Post-operativeBrachytherapy) < 2 cm TRIMBLE 7052Clinical Stage IOveralldisease-specificsurvival >98% 1998G1-2 Endometrioid CAREY 227Clinical Stage IOverallrelapse-freesurvival 95% 1995 G1-2 Endometrioidwithoutlymphadenectomy Invasion < 50% ELTABBAKH 302 Stage I G1-2 Overalldisease-specificsurvival 98.9% 1997 Invasion < 50% withoutlymphedenectomy W= negative(57% receivedlymphadenectomy) CHAN 5556Stage Ia G1-3No survival benefit associatedwith a 2006 Stage Ib G1-2 more extensivelymph-noderesection; p= 0.23 Endometrioidextensivelymph-noderesection; p= 0.23 Chan, Lancet 2007

  12. SURVIVAL BENEFITS REMOVING BENIGN LYMPH NODES AUTHOR No. PTS INCLUSION OUTCOME EXENT OF BENEFIT (year) CRITERIA BENEFIT FROM KILGORE 649Clinical Stages I-II Multiple site  4 pelvic node sampling High-Risk, p= 0.0006 (OS) 1995 No sarcomas vs no node sampling Low risk, p= 0.026 (OS) CRAGUN 509Clinical Stage I-IIaMore extensive lymphadenectomy 5-yrs OS 200579% vs 88% - p= 0.013 ( 11 vs > 11 Nodes) CHAN 12333FIGO Stages I-IVMore extensive lymphadenectomy 5-yrs improved with extent 2006 (1, 2-5, 6-10, 11-20, > 20 nodes) of surgery Stages IbG3, Ic, II-IV G1-2 (75.3, 81.5, 84.1, 85.3, 86.8%) MARIANI 137High-Risk disease More extensive para-aortic5-yrs OS 2000 No Stage IV lymphadenectomy 71% vs 85% - p=0.06 (< 5 vs  5 Nodes) LUTMAN 467FIGO Stage I-IIMore extensive lymphadenectomy 5-yrs OS 2006 High-Risk Histology 64% vs 90% - p <0.001 ( 11 vs > 11 Nodes) Chan, Lancet 2007

  13. AlgorithmsDecision-Making 2 Adjuvant therapy: ch/Rt / RT /Ch Thomas & Aalders 2007

  14. AlgorithmsDecision-Making STAGE ALL Failing to stage even low risk pts,may miss significant numbers of pts with extra uterine disease, particularly since pre surgical G &Inv is realtive inaccurate. Outcome data do not support this assumption ONLY 4% of 922 pts low risk disease and no surgical staging or adjuvant therapy subsequently recurred. Thomas & Aalders 2007

  15. AlgorithmsDecision-Making From these data, one can estimate that the number in whom nodal/extra uterine disease was present is about 5%. The patters of failure predict that 3/5 will recur in the pelvis alone and 2/3 will be salvaged with RT at the time of relapse Thus in low risk negligible gains come from attending accurately know the nodal status by staging Incidence of N+ is low, morbidity rate for surgical staging is 6-7%, recurences are pelvic, and salvage therapy is significant Thomas & Aalders 2007

  16. AlgorithmsDecision-MakingUNSTAGED “HIGH RISK” Subset analysis in “high-risk” (grade 3, > 50% myometrial tumor infiltration) clinical stage I endometrial carcinoma patients Thomas & Aalders 2007

  17. AlgorithmsDecision-Making 3 STAGING ONLY “HIGH RISK” Age,G2-3, 3/3 inv,LVSI pos 1/3 high risk of recurrences in N- No information on EBRT omission GOG: rec. from 12 to 3% but OS 86vs92 Thomas & Aalders 2007

  18. AlgorithmsDecision-Making 3 STAGING ONLY “HIGH RISK” Thomas & Aalders 2007

  19. Specificquestions on PA nodes • Whichpts are mostlikelytohavepara-aorticnodalinvolvement? • In whichgroupissystematic PA nodaldissectionjustified? • In howmanyisdiseaseconfinedtolymphnodes? • What are the incrementalsurvivalresultsofdetecting and treating PA nodalinvolvement?

  20. Para Aorticnodesinvolvement • Overallrisk: stage 1 4%-6% • Grosspelvicnodes: 55% • Grossadnexaldisease: 43% 98% • Outer-thirdinvasion: 18% • Pelvicnodes+: 47% • Othersites & PA node 50% (50% nodeonly) With unsophisticated techniques (45-50Gy), approx 40% may achieve long term DFS (range 35-75%). Thus 1-2/100 pts are cured by virtue of surgical detection and treating involved PA. Thomas & Aalders 2007

  21. Percentradiationuseaftersurgery, bysurgeon & FIGO stage

  22. Lymph Node Assessment by surgeon: General Gynecologist vs Gynecologic Oncologist No. 204 No. 9954 Partridge, 1999 Roland, 2004

  23. ILIADE II - LINCESystematicPelviclymphadenectomyversus no lymphadenectomy Mario Negri Institute, Milan (MANGO)

  24. Pelvicnodesinvolvement • Stage I (welldifferentiatedtumour, superficialmyometrialinvasion): 3-5% • Stage I (undifferentiatedtumour, deepmyometrialinvasion): 20% ASTEC, Lancet 2009

  25. 537 pts. Stage I Intra-operatoryrandomization NO LYMPHADENECTOMY LYMPHADENECTOMY

  26. ILIADE II - LINCE

  27. Median N° of removed nodes *P< .001

  28. Patientswith at least 1 N+ P< .001

  29. Surgery * P< .001

  30. AdjuvantTherapies

  31. Complications *P< .001

  32. Sitesofdiseaserecurrence

  33. Disease Free Survival 81.7 81.0 events total ---- Lymphadenectomy 42 264 ___ No lymphadenectomy 36 250 % χ2=0.17; P=0.68 months

  34. OverallSurvival 90.0 85.9 events total ---- Lymphadenectomy 30 264 ___ No lymphadenectomy 23 250 % χ2=0.45; P=0.50 months

  35. ASTEC surgical trial 2009 Iliac & para-aortic nodes Mean count: 12 nodes

  36. ASTEC, Lancet 2009

  37. ASTEC, Lancet 2008

  38. ASTEC, Lancet 2008

  39. CochraneReview 2010

  40. Survivaleffectofpara-aorticlymphadenectomy in endometrialcancer(SEPAL study): a retrospectivecohortanalysis Todo et al 2010

  41. Para-aortic lymphadenectomy has survival benefits for patients at intermediate or high risk of recurrence. • Pelvic lymphadenectomy alone might be an insufficient surgical procedure in patients at risk of lymph node metastasis

  42. Cox regression analysis of overall survival with pelvic and para-aortic lymphadenectomy compared with pelvic lymphadenectomy alone according to risk of recurrence Todo et al 2010

  43. Correspondence(The Lancet, August 2010) • Study over long time change in staging and management • Are PA nodes involved at preoperative imaging? • Surgical morbidity? LathaBalasubramani, Desiree F Kolomainen, MarielleNobbenhuis, Jane Bridges, Desmond Barton • Inguinal lymphadenectomy as part of the routine systematic pelvic lymphadenectomy: low incidence and extend the morbidity • Include recent FIGO staging • Selection patients and surgery details • Bias: 2 different hospitals Roy Kruitwagen, Harold Pelikan,Hans Trum

  44. Retrospective review 2000-08 • 352 patiens • “Our data suggest that the number of lymph node stations sampled, and not the number of nodes removed, is a more accurate predictor of lymph node status in endometrial carcinoma.”

  45. The purposeofthisstudywastoidentifypracticepatternsamonggynecologiconcologistswhenperforming a lymphnodeevaluationduringstagingforendometrialcancer. • A self-administeredsurveywas sent via emailtoall SGO members, the surveyaddressedsurgicalapproach, algorithmsusedtodeterminestaging, and anatomiclandmarksdefininglymphadenectomy.

  46. 40% members responded. • 40% prefer laparotomy, • 31% perform robotic surgery, • 29% use laparoscopy. • 53% never/rarely use frozen section to determine whether or not to perform lymphadenectomy. • A majority perform staging on all grade 2 and grade 3 cancers (66% and 90%, respectively). • When performing paraaortic lymphadenectomy, 50% use the IMA as the upper border and 11% take the dissection to the renal vessels. Conclusions Current controversies in surgical staging for endometrial cancer are reflected in the practice patterns among gynecologic oncologists. At this point it is unclear if standardizing surgical practice patterns will improve outcomes for patients with endometrial cancer.

  47. In low risk patients  no evidence of benefits perfoming systematic lymphadenectomy In high risk patients  strong evidence against performing systematic lymphadenectomy except of one retrospective study Open question  evaluation of nodal status (FIGO stage) Conclusions

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