Clinical Fellow Gynaeoncology Musgrove Park Hospital, Taunton Regional Outcomes for Surgical Management of Early Stage Cervical Cancer Dr S Coleridge Clinical Fellow Gynaeoncology Musgrove Park Hospital, Taunton ST6 OOPR

Women want to know why we are recommending a particular treatment LACC data presented Consensus to inform women about to undergo a radical hysterectomy of unpublished trial findings Informed consent Montgomery ruling Women want to know why we are recommending a particular treatment Can provide local data to help inform shared decision making SGO, New Orleans March IGCS, Japan August

Randomised Controlled Trial Vs Retrospective Cohort Randomly assign participants to control group (open surgery) or intervention group (minimal access surgery) Gold standard of evidence based medicine Minimise bias Control for confounding factors Observational Middle of the hierarchy of evidence Useful to inform clinical practice

Laparoscopic radical hysterectomy Started in 1990s

Decreased treatment related morbidity (8%) Shorter hospital stay LACC Hypothesis Minimal access surgery is cost effective, improves QoL and pelvic floor function with equivalent overall survival to open surgery Decreased treatment related morbidity (8%) Shorter hospital stay Less post op pain Reduced analgesic consumption Equivalence measured by disease free survival(DFS) within 7.2% of open DFS rate

Laparoscopic Radical Hysterectomy “I'm 5 weeks post op now and feel great. I'm starting back to work next week. My incision sites are still a little sore” “I wanted to say that I felt keyhole surgery was right option for me as the recovery time is quicker and this was important for me as a single parent of 3 kids and limited family support” https://www.jostrust.org.uk/forum

Open Abdominal Hysterectomy “It's taken 4 months to start to feel ok-ish” “I'd say for anyone having the abdominal surgery....this is a hard recovery but it does get better, from speaking to people having had this op it does take a couple of months more than keyhole to get to the milestones they give you. Take it steady!” https://www.jostrust.org.uk/forum

Inclusion criteria FIGO stage 1a1 with LVSI 1a2 1b1 Histological subtype Adenocarcinoma Squamous cell carcinoma Adenosquamous carcinoma Tumour size < 4cm

Exclusions Bristol Devon Gloucestershire Somerset Cases 51 57 42 64 Excluded 9 8 7 Total Included 49 35 Included Timeframe 2001-2017 2011-17 2013-17 2008-2018

Baseline Data SWAGGER Open Lap LACC Age (Mean) 43 44 46 46.1 Total   SWAGGER Open Lap LACC Age (Mean)  43 44  46 46.1 Total in group  30 152 312 (274) 319 (289) 1a2 3% 1 1.3% 2  6% 20 7% 21 1b1 96% 29  92% 140  287 293 1b2 N/A 10 6 simple TLH (2 of which on SHAPE trial)

Post operative Histopathology SWAGGER Open Lap LACC Adenocarcinoma  30% 9 39% 60 21% 58 27% 87  Squamous Cell Carcinoma 67% 20  53%  80 50% 146 214 Adenosquamous carcinoma  N/A  6% 4% 12 3% 9  <2cm 60% 18  56% 85  32% 89 33% 95 >2cm  28% 42 36% 101 97 

Post operative Histopathology contd   SWAGGER Open Lap LACC Differentiation Well Moderate Poor Unknown 16% 50% 10% 13%  9% 35% 14% 21%  40% 22% 28% 11% 21% LVSI Negative Positive 53% 37% 10%  55% 27% 18% 66% 29% 5% 67% 24% Parametria 80% 3% 13% 70% 6% 25%  89% 4% 7% 87% Vaginal Margins 57% 40%  65% 2% 33%  88%

Post op chemoradiotherapy LACC criteria - LVSI / tumour size / stromal invasion

Surgery Vs. Chemoradiotherapy “I went on to have chemo-rads anyway and have been cancer- free ever since, but it is my firm belief that the outcome would have been the same without the unnecessary loss of body parts. …………But in all honesty, I could have done without losing the top 50% of my vagina”

Post operative Histopathology contd   SWAGGER Open Lap LACC Median Nodes 14  17  21 20 Positive Nodes 3%   10%  13% 12%  Negative Nodes  97%  90% 86% 87% Post op CRT 6%  12.5%   28% 29% 

Intra operative complications   SWAGGER Open Lap LACC Any Complication* 3% 6% 10% 12% Bladder Injury  0%  1% Ureteric injury 1% 2% Bowel Injury   0% 0% Blood transfusion*     2% 5% Uterus rupture Vascular Injury Nerve injury* Uterus rupture is not perforation Significant difference in any complication, blood transfusion and nerve injury

Post operative complications   SWAGGER Open Lap LACC Wound Complication* 0% 2% 6.2% 1.4% Vaginal Vault Complication*  2% 0.8% 3.9% Lymphocele formation 1% 1.2% Lymphoedema  10%  8% 0.4% Neuropathy  3% 2.5% VTE 3% Urinary Complications 14% 17.9% 22.6% Cardiac complication*  0% 0.7%

Site of first recurrence   SWAGGER Open Lap LACC Total Recurrences 3 10% 10 6.6% 7 2.2% 24 7.5% Vault  1 33%  5 50% 3  43% 4  17% Pelvis 2 66%  20% 0  0% 7  29% Abdomen 0%   0 4% Distant 14% 8%  Multiple Other 1 13%

SWAGGER progression free survival

LACC Progression free survival

Deaths due to cervical cancer Deaths due to other disease Cause of death   SWAGGER Open Lap LACC Total Deaths 2 5 3 19 Deaths due to cervical cancer  1 3% 4   2 1%  14 4% Deaths due to other disease 0.7%  0 0%  4 Unknown N/A 

SWAGGER Overall Survival Cancer Specific 1 death from disease open group 15y after surgery 3 deaths from disease lap group

LACC OVERALL Survival

Going Forward What Next?

Thank You Mr Milliken Miss Morrison Miss Newton Mr Rolland Mr Hannemann