Surgical Progress in the Management in Gynecologic Cancers

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1 Surgical Progress in the Management in Gynecologic Cancers Stephen J. Lee, MD Assistant Professor September 19, 2018

2 Nothing to disclose DISCLOSURE

3 Defining Minimally Invasive Surgery: Hysterectomy Exploratory Laparotomy Laparoscopic Standard Robotic VAGINAL HYSTERECTOMY is still the LEAST invasive!

4 WHY MIS Treatment for Gyn Cancer Patient Surgeon Hospital 1. Becoming a surgical candidate 2. Reduced Complications 3. Back to Work/ Family 1. Better ergonomics 2. Advanced tech 3. Better surgery 1. Outcomes 2. Cost 3. Cutting edge

5 Advantage of MIS (over open surgery) PATIENT SURGEON HOSPITAL Decreased wound infection Ergonomics Free up beds Less blood loss Patients home sooner Less Readmissions Less pain Faster Recovery Shorter Length of Stay Less complications / Less readmissions Better optics Better quality care Marketing

6 But.are OUTCOMES BETTER???

7 Why NOT use of Minimally Invasive Surgery?? Omentum Bladder Peritoneum Colon

8 UTERINE CANCER

9 Uterine Cancer Most common gynecologic cancer Average age of diagnosis: 61 Affects many women age Up to 25% diagnosed BEFORE menopause Risk factors: Obesity No prior pregnancies Late menopause Genetic causes: HNPCC / Lynch Syndrome

10 Surgical Staging Uterus, cervix, fallopian tubes, ovaries lymph nodes in abdomen/pelvis, pelvic washings

11 Randomized Control Trials for Uterine CA: Laparoscopic vs Open Hysterectomy GOG LAP2 (USA) LACE (Aus, NZ, Hong Kong) N Population Lymph Node Staging Primary Endpoint Clinical Stage I,IIA; All grades Pelvic LN Para-aortic LN Recurrence-free survival Clinical Stage I; All grades Pelvic LN ± Para-aortic LN None* I: QOL II: Disease-free survival Dutch Study Clinical Stage I, grade 1 or 2 or Complex atypical hyperplasia None * = Lymphadenectomy could be omitted in morbidly obese, Gr1 or 2 with <50% myometrial invasion or medically unfit (60% TLH, 32% TAH) Walker et al JCO 2009; Val Gebski et al Lancet Oncol 2010; Mourits et al Lancet Oncol 2010 Major complication rate

12 Summary of Phase III Trials: Laparoscopy vs Open surgery for Treatment of Uterine Cancer GOG LAP2 LACE Dutch Lsc Open Lsc Open Lsc Open N Convert to Laparotomy Intraoperative Complications Mod-severe postoperative complications Hospital Stay (Median, days) OR Time (Median, min) 24% - 4% - 11% - 10% 8% 7% 6% 3% 4% 14% 21% 12% 23% 12% 11% Walker et al JCO 2009; Val Gebski et al Lancet Oncol 2010; Obermair et al. Eur J Can 2012; Mourits et al Lancet Oncol 2010

13 GOG LAP2: Laparoscopy is Not less effective to Laparotomy Walker et al JCO Median followup: 59 months HR: 1.14 (90%lower CI 0.92; 95% upper CI 1.46)

14 LACE: QOL is Better in the Laparoscopic arm Physical Functional Emotional Social Endometrial Val Gebski et al Lancet Oncol 2010

15 Combining Uterine Cancer Surgery with Uterine Prolapse Surgery Add video Video: C. Chung and E. Han

16 Lymphedema and Lymphadenectomy V. Beesley et al 2007 Cancer

17 Does Extent of Nodal Sampling Influence Symptomatic Lymphedema? N. Abu-Rustum et al 2006 Gynecol Oncol

18 Adverse Outcomes with Axillary Surgery in Breast Cancer Rao et al 2013 JAMA

19 Sentinel Lymph Nodes in Uterine Cancer 78% detection rate 93% sensitivity S. Kang et al 2011 Gyn Onc

20 Cervical Injection for Sentinel Lymph Node Detection in Uterine Cancer How et al 2012 Gyn Onc

21 DaVinci Robot Firefly Technology to Detect SLN R. Holloway et al 2012 Gyn Onc EC Rossi et al 2012 Gyn Onc

22 NCCN Guidelines: Sentinel Lymph Node Technique is an Option

23 NCCN Guidelines: Sentinel Lymph Node Technique is an Option

24 Summary: MIS in Uterine Cancer MIS should be utilized in treatment of apparent early stage endometrioid endometrial cancer Surgical staging with sentinel lymph node technology is an option Unclear whether MIS is safe option for patients with aggressive histology (grade 3 endometrioid, serous, carcinosarcoma, clear cell), and patients with advanced disease

25 CERVICAL CANCER

26 Cervical Cancer: Global Problem

27 Cervix Cancer Affects Young Women C. Kosary, Chpt 14, SEER Survival Monograph 2007

28 Human Papilloma Virus Lee et al J Gynecol Oncol 2016

29 2009 FIGO Staging of Cervical Cancer Operate IIA1 4cm IIA2 > 4cm Figure adapted from Monk and Tewari JCO 2007

30 FIGO Staging of Cervical Cancer Palliative Chemo/ Clinical Trial/ Hospice Chemo/ Radiation Monk and Tewari JCO 2007

31 Radical Hysterectomy Initially described by Wertheim from Vienna in 1912 Modifications by Okabayashi (1921) and Meigs (1944)

32 Terminology/Classification System for Radical Hysterectomy Ventral Parametrium Lateral Parametrium Deep Uterine Vein Dorsal Parametrium Cibula et al. 2011, 122:264

33 Robotic assisted Laparoscopic Radical Hysterectomy Procedure Add video

34 Retrospective Data MIS in early stage Cervical Cancer Laparoscopic radical hysterectomy shows reduction in blood loss, postoperative complications, and hospital stay compared to open approach. No significant difference in 5-year DFS and OS. (N=1,539) Wang Y, Deng L, Xu H, Zhang Y, Liang Z. BMC Cancer 2015 Robotic radical hysterectomy is associated with less blood loss, lower transfusion rates, lower wound related complications, and shorter hospital stay compared to open radical hysterectomy. (N=4,013) Shazly S, Murad M, Dowdy S, Gostout B, Famuyida A. Gyn Oncol 2016 Disease recurrence and survival not different between robotic radical hysterectomy and open radical hysterectomy. (N=491) Sert BM, Boggess JF, Ahmad S, Jackson AL, Stavitzski NM, Dahl AA, Holloway RW EJSO 2016

35 But Phase III data lacking until LACC trial in early stage Cervical Cancer Phase III randomized trial comparing MIS vs open radical hysterectomy in cervical cancer International, multicenter

36 LACC trial in early stage Cervical Cancer Primary objective Demonstrate that MIS approach was within 7.2% of the DFS rate of the open approach Conclusions Disease-free survival at 4.5 years for minimally invasive radical hysterectomy was inferior compared to the open approach Minimally invasive radical hysterectomy was associated with higher rates of loco/regional recurrences Results of the LACC Trial should be discussed with patients scheduled to undergo radical hysterectomy Only 16% of the MIS group had radical hysterectomy via robotic approach

37 General Complications Related to Radical Hysterectomy Vesicovaginal fistula 1% Ureterovaginal fistula 2% Severe bladder atony 4% Bowel obstruction (requiring surgery) 1% Lymphocyst (requiring drainage) 3% Pulmonary embolus 1% Thrombophlebitis 2% Disaia and Creasman eds. Clinical Gynecologic Oncology 2007

38 Issues from Conventional Radical Hysterectomy Bladder dysfunction Anorectal dysfunction Sexual dysfunction Sensory loss Constipation Orgasmic problems Storing and voiding dysfunction Sensation of incomplete evacuation Dyspareunia Urinary incontinence Excessive dyschezia Sexual dissatisfaction Detrussor instability Tenesmus Vaginal dryness - Bladder dysfunction: 70-85% - Bowel dysfunction: 42%

39 Potential Injury Sites to Pelvic Nerves during Radical Hysterectomy Uterosacral Ligament Paravaginal Tissues Lateral Parametria/Deep Uterine Vein Fujii et al 2007 Gyn Onc 107:4

40 Minimizing Nerve Damage and Improving QOL Perform less radical surgery and decrease amount of parametrial tissues to be removed Preserve nerves without reducing radicality of surgery

41 Minimizing Radicality in Early Cervix Cancers 243 patients IB1 and IIA Type II Type III 5 yr Overall Survival 81% 77% 5 yr disease free survival 75% 73%

42 Minimizing Radicality in Early Cervix Cancers Type II vs Type III Late Complications % Receiving Radiotherapy Type II Type III 28% 38% 54% 55% Type I vs Type III Grade 2-3 Complications % Receiving Radiotherapy Type I Type III 45% 84% 69% 55%

43 Nerve-Sparing Radical Hysterectomy Goal is to preserve autonomic nerves that are important for urinary, bowel, and sexual health, while maintaining radicality of surgery T.Kato Jpn J Clin Oncol 2003

44 Benefits of Nerve Sparing Radical Hysterectomy Quality of life issues Bladder, bowel, sexual health Oncologic outcomes Survival, recurrence

45 Benefits of Nerve Sparing Radical Hysterectomy 4 systematic review/meta-analyses 4 randomized clinical trials Low number of patients (25,29, 65,86) In one study, patients received neoadjuvant chemotherapy and methods not clearly describing randomization process In one study, primary objective with detailed statistical analysis not provided

46 Limitations of Meta-analysis and Review Small number of studies Low quality of randomized studies Lack of control groups or use of historical controls Short interval followup time Confounded by neoadjuvant or adjuvant treatments Single surgeon or single center data Lack of standardized techniques

47 NSRH- SHOULD BE Standard of Care for Early Cervical Cancers? Significant benefits to bladder and possibly bowel and sexual health compared to conventional radical hysterectomy Feasible to perform Radicality can be maintained Complications similar to or less than conventional radical hysterectomy

48 NSRH- Should NOT Be Standard of Care for Early Cervical Cancers? Number of modifications to original Okabayashi surgery How to simplify and standardize? Which is best method? Can you spare nerves without impairment of surgical radicality? Current randomized control trials have limitations and have not established equivalent outcomes of NSRH to conventional radical hysterectomy

49 Current Clinical Trials: Less Radical Surgery Trial Title n MD Anderson PI: Schmeler NCIC Clinical Trials Group To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features (< 10 mm stromal invasion, no LVSI, tumor size 2 cm; SCCa all grades, Adenocarcinoma gr 1 or 2) A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE). 100 NCT NCT From:

50 Current Clinical Trials: Nerve Sparing Trial Title n Mansoura University Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy Stage IA2-IIB. - Phase 2 C1 type radical hyst - Phase 3 with randomization to C1 vs C2 30 NCT Asan Medical Center Shanghai GOG The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer. A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study. Primary objective is to assess preservation of pelvic nerve plexus, PVR <50ml at POD4, length of time for indwelling catheter. 146 NCT NCT From:

51 OVARIAN CANCER

52 HIPEC in ovarian cancer NEJM article

Chemotherapy#1 Interval Debulking Surgery Chemotherapy#1

53 Ovarian Cancer: Natural History Signs/Symptoms Chemotherapy# 2 Surgery Surgery/Staging Chemotherapy#1 Chemotherapy#1 Interval Debulking Surgery Chemotherapy#1 Chemotherapy#3 Chemotherapy#4? Maintenance Therapy Palliative Care/Hospice

54 Why NOT use MIS for ovarian cancer? Omentum Bladder Peritoneum Colon

55 MIS in Ovarian Cancer - Potential Indications Early Stage Ovarian Cancer Upfront Debulking surgeries Triage system for upfront debulking vs neoadjuvant chemotherapy Recurrent cancer debulking surgery with limited disease

56 MIS in Ovarian Cancer - Triage to Upfront Debulking vs Neoadjuvant Chemotherapy Triage system for initial debulking vs neoadjuvant chemotherapy Goal: determine whether patient can be spared from suboptimal tumor debulking

57 Fagotti Score Fagotti score to predict likelihood of optimal tumor debulking ( 1 cm residual disease) Laparoscopic features Peritoneal carcinomatosis Diaphragmatic disease Mesenteric disease Omental disease Bowel infiltration Stomach infiltration Liver metastasis Predictive index value (PIV) score

58 Omental Cake Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

59 Peritoneal Carcinomatosis Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

60 Diaphragmatic Carcinomatosis Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

61 Mesenteric Retraction Score = 2 Fagotti et al 2013 AJOG 209:462e1

62 Bowel Infiltration Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

63 Stomach Infiltration Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

64 Superficial Liver Metastasis Score = 2 Score = 0 Fagotti et al 2013 AJOG 209:462e1

65 Criteria for S-LPS ECOG 2 No contraindications for laparoscopy Large abdominal mass precluding laparoscopy Disease infiltrating the abdominal wall

66 Concerns Feasibility and reproducibility of S-LPS at academic and community centers Assessment of mesenteric retraction and extensive small bowel involvement Having appropriate surgical teams/expertise for upper and lower abdominal surgeries Need survival outcomes of patients undergoing S-LPS and treated with primary debulking surgery or interval debulking surgery

67 Ongoing Clinical Trials SCORPION trial Comparison of surgical complications of primary surgery and interval debulking surgery Stage IIIC ovarian cancer patients with PIV 8-12 Mission Trial Phase II multicenter feasibility and early complication rates of total laparoscopic or robotic interval debulking surgery in those with complete or partial response to neoadjuvant chemotherapy

68 LapOvCa-Trial Rutten et al BMC Cancer :31

69 MIS in Ovarian Cancer-Limitations Adequate exposure of surfaces Missed lesions in early stage disease Access to paraaortic nodes up to the renal vessels Concern for port site metastasis in ovarian cancers Intraoperative spillage of mass Duration of debulking and can we truly achieve no gross residual disease with MIS? Debulking of isolated disease- is it really isolated? Training of MIS gynecologic oncologists for complex surgeries

70 Final Thoughts

71 Moving Forward Training Current MDs Medical student Residents Fellows Certification New Platforms Cost Quality Advancing technology

72 MIS in Treatment of Gynecologic Cancers 1. Primary hyst 2. Staging 1. Decision for debulking vs NACT 2. Interval Debulking 3. Isolated recurrence 4. Intraperitoneal therapy 1. Simple / radical hyst 2. Staging 3. Exenterations

73 Thank you for your attention

Laparoscopic Management of Early Stage Endometrial Cancer. B. Rabischong, M. Canis, G. Le Bouedec, C. Pomel, J.L Achard, J. Dauplat, G.

Laparoscopic Management of Early Stage Endometrial Cancer B. Rabischong, M. Canis, G. Le Bouedec, C. Pomel, J.L Achard, J. Dauplat, G. Mage Early Stage of Endometrial Cancer most of cases diagnosed (clinical