17th eso-esmo masterclass clinical oncology...dextra a. renalis dextra a. mestenterica inf. v....

Surgery in Gynecological Cancer

J. Sehouli

Director of the Department of Gynecology and

Center for Oncological Surgery ESGO Ovarian Cancer Center of Excellence

Charité Comprehensive Cancer Center Charité/ Campus Virchow-Klinikum

University of Berlin

©Sehouli 2018 Charité Berlin

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http://www.charite.de/de/

Modifikationen

Preperation of ureter

Resection of

Lig. sacro-uterinum

Resection of parametry

Vaginal cuff

Adnektomy

Nervesparing

techniques

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early versus advanced

Prognostic factors: stage, stroma

infiltration,V1,L1,(Grading), lymph node,

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Plexus hypogastricus

inferior

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Blasen- und Rectumpfeiler keine einheitlichen Platten...

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Compartments of the pelvic floor

1 Posterior C. Anorectal

1

2 Medial C. Uterovaginal

2

3 Anterior C: Vesicourethral

3

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sensitiv resisistent

Deperitonealisierung 43% 51%


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Surgery

Preoperative management

Intraoperative management

Postoperative management


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What are the drivers in complication?

Surgical Technique and comlication depend on various

factors;

therapy

tumor biology/tumor pattern

health status, comorbidities, comedication, nutrition

status

cervical cancer, endometrial cancer, ovarian previous

therapy (eg radiation, surgery, chemotherapy,

complications)

health status of the patients (prior, during and after

surgery)

infrastructure of the clinic

experience of the surgeon(s) and the whole medical

team

luck


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detailled

exploration of the

abdomen

infragastr. omentectomy

Pelvic / paraaortal

lymph node

dissection

total

hysterectomy,

bilateral salpingo-

oophorectomy

Indication for

bowel resection

Peritonectomy /

Infrared

contactcoag.

Sehouli/ 2006


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V. renalis sinistra

V. cava sinistra

V. cava

dextra

A. renalis dextra

A. mestenterica inf.

V. renalis dextra

A. Iliaca dextra

A. Iliaca sin

V. ovarica sinistra Ureter sin.

Plexus

hypogastricus

Aorta abdominalis

V. ovarica dextra

N. Ilio-inguinalis sin ©Sehouli 2017 Charité Berlin

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Risk factors for venous thromboembolism – multivariate

analysis (Cox regression) in operated patients with

primary ovarian cancer under systemic chemotherapy in

76 out of 2743 patients.

Variable Hazard Ratio ± Std. Err. [95% Conf. Interval] P>|z|

Age (35-81y) /10yrs 1.4 ± 0.2 1.1 – 1.8 0.006

BMI

(vs. < 30 kg/m2) 3.2 ± 0.8 2.0 – 5.2 <0.001

FIGO IIIc or IV

(vs. FIGO <IIIc) 1.0 ± 0.3 0.6 – 1.7 0.959

Chemotherapy*

(yes vs. no) 0.2 ± 0.1 0.1 – 0.7 0.009

Ascites

(yes vs. no) 1.5 ± 0.3 0.9 – 2.3 0.123

Paraaortic

lymphadenectomy*

(yes vs. no)

.5 ± 0.2 0.3 – 1.0 0.059

Pelvic

lymphadenectomy

(yes vs. no)

1.1 ± 0.3 0.6 – 2.0 0.832

*protective Fotopoulou, duBois et

Sehouli

J Clin Oncol. 2008 Jun

1;26(16):2683-9

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Risk factors for mortality – multivariate analysis (Cox

regression) in operated patients with primary ovarian

cancer under systemic chemotherapy.

in 76 out of 2743 patients.

Fotopoulou, duBois et

Sehouli

J Clin Oncol. 2008 Jun

1;26(16):2683-9

Variable Hazard ratio 95% Confidence interval p-value

Age (35-81y) /10yrs 1.17 1.11 – 1.23 < 0.001

FIGO stage IIIc or higher

(vs. FIGO < IIIc) 1.68 1.46 – 1.93 < 0.001

Chemotherapy* (yes vs. no)

0.48 0.27 – 0.88 0.017

Incomplete tumor resection (i.e. tumor

residuals >0mm)

(yes vs. no)

2.76 2.41 – 3.16 < 0.001

Pulmonary embolism

(yes vs. no) 2.86 1.82 – 4.50 < 0.001

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Abstr. 5500: LION – LYMPHADENECTOMY IN

OVARIAN NEOPLASMS.

A prospective randomized AGO Study Group led

Gynecologic Cancer Intergroup trial. AGO OVAR OP3/ENGOT-ov31.

Philipp Harter1, J. Sehouli2, D. Lorusso3, A. Reuss4, I. Vergote5, C. Marth6,

JW Kim7, F. Raspagliesi8, B. Lampe9, F. Landoni10, W. Meier11, D. Cibula12,

A. Mustea13, S. Mahner14, I. Runnebaum15, B. Schmalfeldt16, A. Burges14,

R. Kimmig17, U. Wagner18, A. du Bois1

1 AGO & Essen, Germany, 2 AGO & Berlin, Germany, 3 MITO & Milan, Italy, 4 KKS Marburg, Germany; 5 BGOG &Leuven, Belgium, 6 AGO-Austria & Innsbruck, Austria,7 KGOG & Seoul, South Korea, 8 MITO & Milan, Italy, 9 AGO & Düsseldorf, Germany,10 MaNGO & Milan, Italy, 11 AGO & Düsseldorf, Germany, 12 AGO & Prague, Czech Republic, 13 AGO & Greifswald, Germany, 14 AGO & Hamburg, Germany, 15 AGO & Jena, Germany,16 AGO & München, Germany,

17 AGO & Essen, Germany, 19 AGO & Marburg, Germany

AGO Study Group NCT00712218

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The “LION” Study: Characteristics of surgery

LNE (%) No LNE (%) P-

value

Bilateral Salpingo-

oophorectomy*

319 (98.8) 320 (98.8) 0.99

Hysterectomy* 321 (99.4) 322 (99.4) 0.99

Omentectomy 319 (98.8) 322 (99.4) 0.41

(Partial) peritonectomy •Pelvis

•Paracolic

•Diaphragm

291 (90.1) 276 (85.5)

193 (59.8)

173 (53.6)

291 (89.8) 278 (85.8)

208 (64.2)

196 (60.5)

0.99

Gastrointestinal tract resection Stoma

169 (52.3) 34 (10.5)

167 (51.5) 24 (7.4)

0.84 0.17

Splenectomy 62 (19.2) 56 (17.3) 0.53

Porta hepatis/lesser omentum 61 (18.9) 69 (21.3) 0.44

Partial pancreatectomy

Partial hepatectomy

Pleurectomy

7 (2.1)

27 (8.4)

20 (6.2)

7 (2.1)

28 (8.6)

24 (7.4)

0.99

0.90

0.54

Complete resection 321 (99.4) 322 (99.4) 0.99

* Including earlier performed

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The “LION-Study”: Characteristics of surgery

Presented by: Philipp Harter

AGO & KEM

Essen, Germany

LNE (%) No LNE (%) Difference p-value

Study procedure according to

randomisation

320 (99.1) 313 (96.6)

Resected LN total (median, IQR)

Para-aortic LN

Pelvic LN

57 (45-73)

22 (16-33)

35 (26-43)

Lymph node metastases 180 (55.7)

Duration (median, IQR) [min] 340 (270-

420)

280 (210-

360)

+ 1 hour <0.001

Blood loss (median, IQR) [ml] 650 (400-

1000)

500 (300-

900)

+ 150 ml <0.001

Transfusions Massive transfusions (> 10 RBC/24h)

205 (63.7) 7 (2.2)

181 (56.0) 2 (0.6)

+ 8% 0.005 0.09

Fresh-frozen plasma 117 (36.3) 96 (29.7) + 7% 0.07

Intermediate/Intensive Care

Unit

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LION: Post-surgical outcome

Presented by: Philipp Harter

AGO & KEM

Essen, Germany

LNE (%) No LNE (%) p-value

Infections requiring antibiotics

Fever > 38.0o Celsius

Sepsis

83 (25.8)

41 (12.7)

6 (1.9)

60 (18.6)

32 (9.9)

3 (0.9)

0.03

0.21

0.31

Thrombosis 7 (2.2) 5 (1.6) 0.56

Pulmonary embolism 12 (3.7) 15 (4.6) 0.56

Secondary wound healing 31 (9.6) 19 (5.9) 0.12

Prolonged ileus (conservative management) 15 (4.6) 17 (5.3) 0.72

Peripheral sensoric neurologic event 7 (2.2) 7 (2.2) 0.99

Peripheral motoric neurologic event 10 (3.1) 8 (2.5) 0.63

Asymptomatic lymph cysts 14 (4.4) 1 (0.3) <0.001

Symptomatic lymph cysts 10 (3.1) 0 0.001

Fistula 5 (1.6) 7 (2.2) 0.56

Readmission rate 40 (12.4) 27 (8.3) 0.09

Rate of re-laparotomy for complications 40 (12.4) 21 (6.5) 0.01

60 day postoperative mortality 10 (3.1) 3 (0.9) 0.049

Platinum + Taxan i.v. 257 (79.6) 274 (84.6) 0.09 17th E

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More than 20 years „Fast track stories“…but

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Kein Aszites

(n = 56)

Aszites

(<500ml)

(n = 42)

Aszites

(>500ml)

(n = 21)

p Wert

Intraoperative Transfusion

0.001

§

No transfusion, n (%) 33 (58.9) 23 (54.8) 4 (19.0)

Transfusion 1 to 9 units, n (%) 21 (37.5) 15 (35.7) 12 (57.1)

Transfusion more than 10 units, n (%) 2 (3.6) 4 (9.5) 5 (23.8)

Höchste Noradrenaline (NA) Gabe

0.019

§

No NA administration, n (%) 34 (60.7) 20 (47.6) 7 (33.3)

Low Dose NA (<0.2µg/kg/min),n(%) 21 (37.5) 16 (38.1) 12 (57.1)

High Dose NA (0.2-0.5 µg/kg/min),n(%) 1 (1.8) 4 (9.5) 2 (9.5)

Very High NA (>0.5 µg/kg/min), n (%) 0 (0) 2 (4.8) 0 (0)

Episoden Hypotension (syst. Arterieller

Blutdruck (SBP) Abfall für 5 min)

SBP < 100mmHg (number) 5.0(2.0;15.75) 9.5(5.0;20.5) 15.0(4.5;24.0) 0.078 #

SBP < 90mmHg (number) 0 (0; 3) 3(0; 6) 4 (0; 8) 0.066 #

SBP < 80mmHg (number) 0 (0; 0) 0 (0; 0.25) 0 (0; 1.0) b 0.046 #

Feldheiser et al. Int J Gynecol Cancer 2014; 24: 478-487.

Impact of Ascites on the Perioperative

Outcome in Ovarian Cancer

x x

x x

x x

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Different persepctives rgarding volume

management

liberal

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liberal

Restrictiv

Anesthetic view

Differences in observing

and interpetration

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Restrictive Volume-Management!!!

Brandstrup, B. et al., Ann Surg, 2003 17th E

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Hemodynamic curves in pts with ovarian cancer

Feldheiser et al. REDAR, 2016 Mar;63(3):149-158. 17th ESO-E

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The „Charité-Experience“ (n=536 pts)

Jumana Almuheimid, Zelal Muallem, Jalid Sehouli et al

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© Charité/Sehouli/2017

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Overall Survival

complete resected

incomplete resected

© Charité/Sehouli/ ESGO 2017

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SURGICAL CHARACTERISTICS IN ALL PATIENTS WITH

ADVANCED OVARIAN CANCERS UNDERGOING PRIMARY

CYTOREDUCTIVE SURGERY


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POSTOPERATIVE COMPLICATION AFTER PRIMARY CYTOREDUCTIVE

SURGERY IN PATIENTS WITH ADVANCED OVARIAN CANCERS


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PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL IN PATIENTS WITH

ADVANCED OVARIAN CANCER UNDERGOING PRIMARY CYTOREDUCTIVE SURGERY


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Abstr. 5501: Randomized controlled phase III study

evaluating the impact of secondary cytoreductive surgery in

recurrent ovarian cancer: the interim analysis of

AGO DESKTOP III / ENGOT ov20

Andreas du Bois1, I. Vergote2, G. Ferron3, A Reuss4, W. Meier1, S. Greggi5,

P. Jensen6, F. Selle3, F. Guyon3, C. Pomel3, F. Lecuru3, R. Zang7,

E. Avall-Lunqvist6, JW Kim8, J. Ponce9, F. Raspagliesi5,

S. Ghaem-Maghami10, A. Reinthaller11, P. Harter (PI)1 , and J. Sehouli1

1 AGO & Essen, Düsseldorf, Essen, Berlin, Germany; 2 BGOG & Leuven, Belgium; 3 GINECO & Toulouse, Paris, Bordeaux, Clermont-Ferrand, Paris France; 4 KKS Marburg, Germany; 5 MITO & Naples, Milan, Italy; 6 NSGO & Odense, Stockholm, Denmark & Sweden; 7 SGOG & Shanghai, China; 8 KGOG & Seoul, Korea; 9 GEICO & Barcelona, Spain; 10 NCRI & London, UK; 11 AGO-Austria & Wien, Austria

AGO Study Group

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AGO DESKTOP III: Surgery arm (AGO–OVAR OP.4; ENGOT-ov20; NCT01166737)

Presented by: Andreas du Bois

AGO & KEM

Essen, Germany

Duration of surgery (minutes; median /

quartiles)

220 (150 – 300)

Bowel resection 33.2%

Stoma diversion temporary / permanent 3.5% / 3.5%

Blood loss (ml; median / quartiles) 250 (50 – 500)

RBC transfusion 20.3%

Fever > 38°C 4.8%

Antibiotic treatment (mainly for urinary tract

infections)

19.0%

Peri-OP thrombosis 1.1%

Re-laparotomy rate 3.2%

Macroscopic complete resection

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Retrospective evaluation of cytoreductive surgery in ovarian

cancer patients older than 70 years. (Fotopoulou, Sehouli et

al., 2009)

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Procedure

performed

Patients

[%]

(n= 101)

Procedure

performed

Patients

[%]

(n= 101)

Hysterectomy 63 [62.4] Colostomy /

Ileostomy

9 [8.9]

Pelvic LND 41 [40.6] Pancreas resection 0 [0]

Para- aortic LND 37 [36.6] Peritonectomy 57 [56.4]

Intestinal Resection 43 [42.6] Splenectomy 2 [1.98]

Partial resection

urinary bladder

with ureter

reimplantation

1 [0.99] Partial Hepatectomy 0 [0]

Diaphragmatic

Resection

1 [0.99] Partial Gastrectomy 1 [0.99]

Organ involved Patients

[%]

(n= 101)

Organ involved Patients

[%]

(n= 101)

Omentum 65 [64.4] Liver capsule 4 [3.9]

Pouch of Douglas 21 [20.8] Serosa of the

Stomach

6 [5.9]

Pelvic wall 29 [28.7] Diaphragma 31 [30.7]

Uterus 63 [62.4] Abdominal wall 2 [1.98]

Serosa of the urinary

bladder

13 [12.9] Small intestine 33 [32.7]

Splenic hilus 7 [6.9] Mesenteruim 38 [37.6]

Omental bursa 18 [17.8] Large intestine 54 [53.5]

Surgical procedures

performed during primary

tumordebulking surgery in

the elderly patients (>70

years old) with epithelial

ovarian cancer and

intraoperative tumor

dissemination pattern

according to the

„Intraoperative Mapping of

Ovarian Cancer“

documentation tool.

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Surgical outcome – tumor residuals

and morbidity

Patients [%]

(total=101)

Postoperative tumor residuals

None

<0.5cm

0.5-1cm

1-2cm

≥2cm

45 [44.6]

10 [9.9]

7 [6.9]

18 [17.8]

16 [15.8]

Postoperative morbidity

-venous thrombosis

- infection/sepsis

- fistula formation

- ileus

- postoperative bleeding

- renal failure

- neurological impairment

- pulmonary edema

- postoperative lymph fistula

- electrolytic imbalance

- multiorgan failure

- relaparotomy due to

complication

- Death

3 [2.97]

7 [6.93]

4 [3.96]

2 [1.98]

3 [2.97]

5 [4.95]

2 [1.98]

2 [1.98]

2 [1.98]

4 [3.96]

3 [2.97]

10 [9.90]

6 [5.94]

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Impact of cytoreductive surgery on

overall survival

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Kaplan Meier Overall survival curve and data for overall

and progression free survival for elderly patients

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intraoperative

Anesthesia

aspiration

Cardiac arrest

trachea injury

pneumothorax

positioning injury

surgical:

„Operability“

Rogan injuries

bleeding (tumor induced/iatrogen)

nerve leasions (positioning)

postoperative

Internistisch:

Thromboembol.

cardiopulmonary morbidity

Infections

SIRS

Liver failure

Takotsubo Cardiomypathy

surgical:

Fistula/ Perforations, (bowel, pancreas, bladder, stomach,

vessels)

secondary wound healing

peritonitis

hemorraghy

Bowel obstruction

Ischemia/Infarct

lymphorroe

compartmentsyndr.

emboly

COMPLICATIONS

MORBIDITY - MORTALITY ©Sehouli 2017 Charité Berlin

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2010

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...“drains to prevent

lymphocyst formation

can safely be omitted

following radical

hysterectomy and

pelvic LND“

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„FRAILTY“

Subproject of “BIOCOG”

Prospektive Untersuchung etablierter Tests zur

Risikostratifizierung und Prädiktion von postoperativen

Komplikationen bei Patientinnen mit gynäkologischen

Malignomen

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Frailty Studie

Studiendesign: Prospektive nicht-interventionelle klinische

Kohortenstudie

237 Frauen ≥ 18 Jahre mit elektiven chirurgischen Therapie bei

gynäkologischen onkologischen Erkrankungen

Oktober 2015 -Januar 2017

Primärer Endpunkt: Postoperative Komplikationen nach Clavien-

Dindo (30 Tage postoperative)

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http://www.charite.de/de/

Drop-outs N= 5

9 (3.8%) patients has died

Grade V complication according Clavien-Dindo

41(17.3%) experienced a grade≥3b complication

according Clavien-Dindo

Gynecological cancer patients

n = 237 (Median Age 59 years)

Frailty Ergebnisse

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Pre-Frail

p< 0,009 OR 3,3 95%CI 1,344- 8,103

Frail

P< 0,001 OR 4,1 95%CI 1,736- 9,803

Frailty Ergebnisse

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• ASA, BMI, Albumin, Potassium and Fried Frailty Score are associated with postoperative complications (Clavien- Dindo IIIB - V)

• Hand grip strength is associated with postoperative delirium in

elderly patients

• feasible to conduct during the busy clinical routine

• an evidence-based frailty score could also provide the option for interventions that reduce the amount of vulnerability pre-surgery

Conclusion

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Logistische Regression

Complications (IIIB-V)

Age p=0.34, OR 1.01 (95% CI 0.98-1.03)

Age>70 p=0.25, OR 1.51 (95% CI 0.73-3.11)

Barthel-Index <100 p=0.003, OR 3.62 (95% CI 1.55-8.43)

IADL p=0.03 OR 0.58 (95%CI 0.35-0.956)

ASA p<0.0001, OR 2.98 (95% CI 1.65-5.38)

Charlson Comorbidity P=0.015, OR 2.33 ( 95% CI 1.18-4.61

Polypharmacy p<0.001, OR 3.40 (95% CI 1.63-7.10)

Albumin<3.5 g/dl p<0.009, OR 3.22 (95% CI 1.33-7.79)

Potassium < 3.6 mmol/L p<0.007, OR 5.11 (95% CI 1.55-16.81)

BMI>30 kg/m2 p<0.001, OR 4.99 (95% CI 2.00-12.43)

Nutritional Risk Score >2 P=0.04 OR 1,51 (95%CI 1.01-2.26)

Frailty Results

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Multivariate analysis


Age p=0.49, OR 0.89 ( 95% CI 0.95-1.02),

ASA p=0.01, OR 2.60 (95% CI 1.20-5.60)

Duration of surgery p=0.012, OR 1.26 (95% CI 1.05-1.52)

Albumin<3.5 g/dl p=0.028, OR 3.37 (95% CI 1.14-10.00)

BMI >30kg/m2 p=0.009, OR 3.81 (95% CI 1.40-10.35)

Potassium < 3.6 mmol/L p=0.02, OR 3.69 (95% CI 1.20-11.38)

Charlson Score > 2 p=0.88, OR 1.06 (95% CI 0.42-2.69)

Polypharmacy p=0.65, OR 1.26 (95% CI 0.41-3.98)

Frailty Results

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Logistische Regression


Bioimpedance Phase angle<4.75 p=0.007, OR 3.08 (95% CI 1.35-7.01)

Sport p=0.05, OR 0.82 (95% CI 0.67-1.00)

Climbing Stairs p=0.001, OR 4.15 (95% CI 1.73-9.98)

Weight loss p=0.41 OR 1.5 (95%CI 0,56-4,00)

Distress Thermo >8 p=0.004, OR 3.90 (95% CI 1.55-9.79)

Pain p<0.001, OR 3.45 ( 95% CI 1.66-7.18)

Fatigue p<0.0001, OR 5.05 (95% CI 2.43-10.52)

Nicotine p=0.009, OR 3.22 (95% CI 1.33-7.79)

Time up to go >9s p<0.001, OR 5.93 (95% CI 2.055-17.12)

Hand grip <18 P=0.01 OR 3.43 (95% CI 1.23-9.53)

MMSE 26-18/30-27 p=0.14 OR 3,00 (95%CI 0.06-13.08)

Frailty Results

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Surgical approach in the „elderly

patient and/or fragile patient“

Healthy and fit „elderly patient“:

according to guidelines

Fragile „elderly patient“:

short time of surgery, priorization of

procedures

(starting with resection of main tumor burden,

en-bloc-resections or rather absolutely

necessary procedures, thorough hemostasis,

as little anastomoses as possible, critical

indication for multivisceral operation

techniques and lymphonodectomy)


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Steps during treatment/operation

Discussion of therapeutic options

Definition of therapeutic aim of surgery (Improvement of

symptoms vs. Improvement of PFS)

Definition of therapeutic concept after surgery

Best preoperative organization and preparation (Less may be

more!)

Best intraoperative assistance (Weniger ist mehr)

Evaluation of abdominal situation, preparation of all relevant

(retroperitoneal) structures without damage

Re-Evaluation and if acquired adaption of therapeutic goal and

alternative and/or following therapy

Identification of emergency exit

Priorization of operative procedures (starting with resection of

main tumor burden, preferably en-bloc-resections, restriction to

small amount of anastomoses)

Postoperative: fast-track

Re-Evaluation and if acquired adaption of therapeutic goal and

alternative and/or following therapy

Pre-OP

OP

Post-OP


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What are the main points?

• Infrastructure (surgery team, back-up)

• Prevent damage! (GI, vessels)

• Don‘t get too impressed by the tumor

burden

• Try to interpret pattern of tumor burden

• Define healthy organ structures

• Define realistic ending of surgery

• Take safe routes (extra- and

retroperitoneal)


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Advice and more…

• Step-wise preparation according to

anatomy (each step makes you more

courageous)

• Use your ressources

• Involve everyone of your team

• Accompany your patients before,

during and after the operation


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Important steps of surgical education

Thorough indication

Understanding of absolute and

relative contraindications

Experience complications

Provoke complications

Realize complications

Prevent complications

Master complications


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17th ESO-E

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17th eso-esmo masterclass clinical oncology...dextra a. renalis dextra a. mestenterica inf. v....

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