endometrial cancer surgery open vs laparoscopic vs robotic surgery advantages, disadvantages, &...

Endometrial Cancer SurgeryEndometrial Cancer SurgeryOpen vs Laparoscopic vs Robotic SurgeryOpen vs Laparoscopic vs Robotic Surgery

Advantages, Disadvantages, & ResultsAdvantages, Disadvantages, & Results

Ginger J. Gardner, MDGinger J. Gardner, MDAssociate Professor, Weill Cornell Medical CollegeAssociate Professor, Weill Cornell Medical College

Associate Member, Gynecology ServiceAssociate Member, Gynecology ServiceDirector, Survivorship ProgramDirector, Survivorship Program

Department of SurgeryDepartment of SurgeryMemorial Sloan-Kettering Cancer CenterMemorial Sloan-Kettering Cancer Center

• Trial DesignProspective Randomized Control Trial

2:1 Randomization Laparoscopy vs LaparoscopyClinical stage I-IIAAll histologic subtypesFull staging Required

Hysterectomy, BSO, Washings, Pelvic & Para-aortic nodal dissection

Conversion to Laparotomy if inaccessible by Laparoscopy

• Short Term Follow-up: Complications, LOS, QOL• Recurrence Rate and Overall Survival

GOG LAP-2GOG LAP-2

GOG LAP-2GOG LAP-2Perioperative OutcomesPerioperative Outcomes

Walker JL, et al. J Clin Oncol 2009;27:5331-5336

Laparotomy Laparoscopy P-value

N 920 1696

Median age (years)Median BMI (kg/m2)

63 (55-71)29 (24-34)

63 (55-72)28 (24-34)

Converted - 434 (25.8%)

Median operative time (min) 130 (102-167) 204 (160-252) <0.001

Complications Intraoperative – any Postoperative – any (grade≥2) Postoperative antibiotic use

69 (8%)191 (21%)211 (23%)

160 (10%)240 (14%)274 (16%)

0.1<0.001<0.001

Hospital stay Stay >2 days Median LOS (days)

245 (94%)4 (3-5)

867 (52%)3 (2-4)

2 (not converted)4 (converted)

<0.001

Medians reported with interquartile ranges

Walker JL, et al. J Clin Oncol 2009;27:5331-5336


Pelvic lymph nodes Any obtained Median number

868 (99%)18 (12-24)

1585 (98%)17 (12-23)

0.18

Para-aortic lymph nodes Any obtained Median number

843 (97%)7 (4-11)

1482 (94%)7 (4-11)

0.002

Stage IIIC 84 (9%) 143 (9%) NS

Medians reported with interquartile ranges

GOG LAP-2GOG LAP-2Oncologic Surgical OutcomesOncologic Surgical Outcomes

Kornblith AB, et al. J Clin Oncol 2009;27:5337-5342.

GOG LAP-2GOG LAP-2Quality of LifeQuality of Life

GOG LAP-2GOG LAP-2Overall SurvivalOverall Survival

Walker, JL et al. J Clin Oncol 2012;30(7):695-700

OS89.8%89.8%

GOG LAP-2GOG LAP-2Types RecurrenceTypes Recurrence


Incidence Port Site Metastasis 4/1696 (0.24%)Stage IV CarcinosarcomaStage IIIC grade 2 EndometrioidStage IIIA grade 2 EndometrioidStage IB grade 2 Endometrioid

No significant difference in types of recurrent disease (local vs distant) between laparoscopy and laparotomy cases

GOG LAP-2GOG LAP-2Recurrence by SubgroupRecurrence by Subgroup


GOG LAP-2GOG LAP-2SummarySummary


Laparoscopy for Endometrial Cancer Fewer post-operative complications Faster recovery Better quality of life Similar nodal counts Similar overall survival All histologic subtypes eligible Low (0.24%) rate of port mets, mostly occurs in already

advanced stage disease No differece in Overall Survival

BUT, 25% Conversion to Laparotomy

Dutch TrialDutch Trial

Mourits MJE, et al. Lancet Oncol 2010;11:763-771.


N 94 185

Median age (years)Median BMI (kg/m2)

6329

6228

Converted - 20 (10.8%)

Median operative time (min)Median EBL (cc)Number days needing pain meds

71200

5

115100

3

<0.001<0.001<0.001

Complications Total major Total minor

14 (15%)11 (12%)

27 (15%)24 (13%)

NSNS

Hospital stay 5 2 <0.001

Resumption normal activities by 6 weeks postop

51 (62%) 129 (76%) 0.002

Laparoscopy were TLH; LND not done in any cases at allQOL better after LSC on 2 (two) SF-36 subscales

Bijen CB, et al. Gynecol Oncol 2011;121:76-82.

“TLH is cost effective compared to TAH…TLH should be recommended as a standard-of-care surgical procedure in early endometrial cancer.”

Dutch TrialCost effectiveness

LACE Trial*LACE Trial*

Janda M, et al. Lancet Oncol 2010;11:772-780.


N 142 190

Mean age (years) 62.7 62.8

Mean operative time (min) 109 138 0.001

Complications Intraoperative Postoperative

8 (5.6%)33 (23.2%)

14 (7.4%)22 (11.6%)

NS0.004

Hospital stay >2 days 139 (97.9%) 72 (37.9%) <0.0001

*Australia, New Zealand, Hong KongLaparoscopy were TLH; All pelvic LND +/- PA LND

Janda M, et al. Lancet Oncol 2010;11:772-780.

LACE TrialQuality of life

Fram2002

Zorlu2005

Zullo2005

Tozzi2005

Dutch trial2010

LACE2010

GOG2009

Total # of cases 61 52 78 122 279 332 2616

OP time NO SAME NO - NO NO NO

EBL YES - YES YES YES - YES

LN counts SAME SAME SAME SAME - - SAME

LOS YES YES YES YES YES YES YES

Complications - - YES - SAME YES YES

QOL - - YES - YES YES YES

Cost-effective - - - - YES - -

Survival - - - SAME - - SAME

Summary of RCTsSummary of RCTsLaparoscopy is BetterLaparoscopy is Better

Natural Evolution of TechnologyNatural Evolution of Technology

Evolution of TechnologyEvolution of Technology

Konrad Zuse’s Z1 (1938)First binary computerMechanical calculator

UNIVAC I – UNIVersal Automatic Computer (1951)First commercial computer

U.S. Census BureauOriginal price: $159,000

Ultimate price: $1.5 million46 systems built and sold

IBM 701– (1953)First commercial IBM computer

$15,000/month rental feeOnly 19 systems built and sold

Evolution of TechnologyEvolution of Technology

Altair (1974)Scelbi (1974)

First personal computerKit that user had to put together, make it work,

and write software256 Byte RAM

$400

IBM 5100 – First IBM PC (1975)50 pounds

Programming language (APL or BASIC)64K storage version

$19,975

Robotic SurgeryRobotic Surgery

• Improved Visualization

• Increased Surgeon Control

• Instrument Functionality

• Computer Enhanced Surgery

Why Robotics?Why Robotics?A New Tool For LaparoscopyA New Tool For Laparoscopy

MSKCC RoboticsMSKCC RoboticsAll servicesAll services

1 0 10 0 110 0 16 0 160 5 15 0 20248

12 0

6216

106

16 0

142137 145

270

309321359

69

6

752

401 367

8737

886

568

423

14497

1223

478

358

116 119

1071

0

200

400

600

800

1000

1200

1400

GYN GU Thoracic Other Total

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 *Jan-Sept

MSKCC Gynecology ServiceSurgical intraperitoneal cases

32% 26% P=0.002

698

945

101 106 137

10

100

200

300

400

500

600

700

800

900

1000

Uterine cancer

Benign CAH Cervical cancer

Adnexal cancer

Vulvar cancer

Case DistributionCase Distribution5/15/07 – 10/2/125/15/07 – 10/2/12

N=1988

Robotics in Endometrial CancerRobotics in Endometrial CancerLiterature reviewLiterature review

Author Year SiteTime period

(months)Total

NConverted

N (%)OR time

(min)EBL (ml)

LOS(d)

Reynolds* 2005 US 20 4 0 257 50 2

Boggess* 2008 US 31 103 3 (2.9%) 191.2 74.5 1

Seamon** 2008 US 26 105 13 (12.4%) 242 99 1

Bell* 2008 US - 40 0 184 166 2.3

Veljovich** 2008 US 13 25 0 283 66.6 1.7

Lowe* 2009 US 70 405 27 (6.7%) 170.5 87.5 1.8

Holloway* 2009 US 21 100 4 (4%) 171 103 1.1

Hoekstra** 2009 US 13 32 1 (3%) 195 50 1

Peiretti** 2009 Italy 24 80 3 (3.7%) 170 50 2

Cardenas** 2010 US 20 102 1 (1%) 222 100 1

Jung* 2010 Korea 33 28 0 193.2 - 7.9

Gocmen* 2010 Turkey 14 10 0 234.6 95 2.8

Leitao** SGO2011 US 38 271 32 (12%) 217 50 1

TOTAL 13 - 70 1305 84 (6.4%) 170 - 283 50 - 166 1 – 7.9

Series with staging and not rad hysts or other*mean; **median

Robotics in Endometrial CancerRobotics in Endometrial CancerLaparoscopic vs RoboticLaparoscopic vs Robotic

Boggess* Seamon* Cardenas* Leitao**

LRSN=81

RBTN=103

P-valueLRSN=76

RBTN=105

P-value

LRSN=173

RBTN=102

P-valueLRS

N=278RBT

N=271P-

value

Conversion 4.9% 2.9% NS 26.3% 12.4% 0.02 5.2% 1% NS 12% 12% NS

Room time (min) 336 305 <0.001 253.5 301 <0.001

OP time (min) 213.4 191.2 <0.0001 287 242 <0.001 178 237 <0.0001 184.5 217 <0.001

EBL (ml) 145.8 74.5 <0.0001 200 88 <0.001 187 109 <0.0001 100 50 <0.001

PLN # 17.4 20.5 0.06 22 21 NS 16.1 13 0.005 16 14 NS

PAN # 6.3 12 <0.0001 11 10 NS 7.2 9 0.07 5 6 NS

Total LN # 23.1 32.9 <0.001 23 22 NS 22.5 21 NS

LOS (days) 1.2 1 0.001 2 1 <0.001 2.3 1.9 NS 2 1 <0.001

Complications 13.6% 5.8% 0.07 14% 13% NS 7.5% 9.8% NS 16% 11% NS

*mean; **medianLRS=standard laparoscopy; RBT=robotically-assisted laparoscopy

Robotics in Endometrial CancerRobotics in Endometrial CancerLaparoscopic vs RoboticLaparoscopic vs Robotic

Boggess* Seamon* Cardenas* Leitao**

LRSN=81

RBTN=103

P-valueLRSN=76

RBTN=105

P-value

LRSN=173

RBTN=102

P-valueLRS

N=278RBT

N=271P-

value

Conversion 4.9% 2.9% NS 26.3% 12.4% 0.02 5.2% 1% NS 12% 12% NS

Room time (min) 336 305 <0.001 253.5 301 <0.001

OP time (min) 213.4 191.2 <0.0001 287 242 <0.001 178 237 <0.0001 184.5 217 <0.001

EBL (ml) 145.8 74.5 <0.0001 200 88 <0.001 187 109 <0.0001 100 50 <0.001

PLN # 17.4 20.5 NS 22 21 NS 16.1 13 0.005 16 14 NS

PAN # 6.3 12 <0.0001 11 10 NS 7.2 9 NS 5 6 NS

Total LN # 23.1 32.9 <0.001 23 22 NS 22.5 21 NS

LOS (days) 1.2 1 0.001 2 1 <0.001 2.3 1.9 NS 2 1 <0.001

Complications 13.6% 5.8% NS 14% 13% NS 7.5% 9.8% NS 16% 11% NS

*mean; **medianLRS=standard laparoscopy; RBT=robotically-assisted laparoscopy

• Increased Rate of MIS Surgery for Endometrial Cancer Patients

• Decreased Post-Operative Pain

• Same Day Hysterectomy

• SLN Fluorescence

Advantages of Robotics Advantages of Robotics over Laparoscopy?over Laparoscopy?

Leitao MM…Gardner GJ. Gynecol Oncol 2012;125:394-399

RoboticsImpact on practice

P<0.001

24%

11%

16%9%


RoboticsImpact on practice

P<0.001

39%

19%

28%

18%

HysterectomyHysterectomyLess pain with robotic approach?Less pain with robotic approach?

Variable ROBOT TLH P-value

N 26 44

Mean age (years) 44.9 42.2 NS

Mean BMI (kg/m2) 30.3 30.5 NS

Mean room time (min) 185 161.7 0.01

Mean OP time (min) 142.2 122.1 0.03

Mean ut weight (g) 212 170.4 NS

Mean EBL (ml) 113.5 98.8 NS

Mean Hgb drop 1.87 1.81 NS

Mean narcotic use (units) 1.2 5 0.002

Mean LOS (days) 1 1.4 0.01

Shashoua, et al. JSLS 2009

Robotics in Endometrial CancerRobotics in Endometrial CancerPostoperative painPostoperative pain

Variable ROBOT LRS P-value

Non-converted cases 239 244 -

IV PCA used 206 (86%) 217 (90%) 0.2

Procedure LAVH TLH Other

0202 (88%)

4 (2%)

189 (87%)28 (13%)

0

<0.001

Basal rate used 3 (2%) 21 (10%) 0.001

Time with PCA (hrs) Median (range) 14.9 (0-51) 16.8 (7-180) <0.001

Total fentanyl dose (ucg) Median (range) 242.5 (0-2705) 367.5 (0-2625) <0.001

Hourly total fentanyl dose (ucg) Median (range)

16.7 (0-122.5) 22.7 (0-132.4) 0.01

Leitao, Gardner, et al. SGO 2011

Robotic approach independently associated with less pain medication use when controlling for PCA medication used, use of basal rate, and time on PCA (P=0.04)

7/27/10 – 9/8/11

Median (range) or N (%)

Total 106

Median age (yrs)Median BMI (kg/m2)Median ASA classPreop diagnosis Endometrial cancer Ovarian cancer Cervical cancer Non-gyn cancer or benignPrior laparoscopy and/or laparotomy

52 (31 - 77)26.8 (18.5 – 56.8)

2 (1 – 3)

42 (40)4 (4)3 (3)

57 (54)53 (50%)

Same day hysterectomySame day hysterectomyOverall baseline cohort characteristicsOverall baseline cohort characteristics

Leitao Jr MM, et al. SGO 2012

7/27/10 – 9/8/11


Median uterine weight (g)Median EBL (ml)Procedures* Simple ComplexMedian room time (min)Median operative time (min)Median time case ended (hr:min)Median intraop crystalloid used (ml)Intraop ketorolac usedTrocar site marcaine used

98 (37 – 874)50 (5 – 300)

55 (52)51 (48)

197 (134 – 351)153 (79 – 289)

13:20 (10:06 – 22:03)1800 (600 – 3000)

75 (71)45 (43)

Same day hysterectomySame day hysterectomyOverall surgicopathologic characteristicsOverall surgicopathologic characteristics


*Simple procedure defined as total laparoscopic hysterectomy +/- BSO; complex procedure defined as TLH +/- BSO and any of the additional: SLN mapping, pelvic and/or aortic LND, appendectomy, omentectomy

7/27/10 – 9/8/11


Median time to discharge* Minutes HoursMedian distance from hospital (miles)Destination postop NY NJ PA CTStayed overnightMedical reason for staying overnight**

345 (146 – 1827)5.75 (2.4 – 3-.5)30.5 (0.2 – 149)

77 (73)24 (23)

3 (3)2 (2)

28 (26)13/28 (46)

Same day hysterectomySame day hysterectomyOverall discharge outcomesOverall discharge outcomes


*From end of case to discharge** Medical reasons: pain, nausea, fever, urinary retention, sinus arrhythmia, intraop complication, minilap, vasovagal (pre/postop); Non-medical reasons: patient desire, weather, late case, long commute

7/27/10 – 9/8/11


UCC postop visit UCC ≤ 48 hrs UCC 48 hrs to ≤ 7 days UCC 7 to 30 daysReadmitted to inpatientReasons for readmission Pelvic hematoma Retained foreign body Non-trocar ventral hernia (incarcerated) Abd wall hematoma, anemia, transfused

8 (7.5)1 (1)3 (3)4 (4)

4 (3.8)

1111

Same day hysterectomySame day hysterectomyOverall post-discharge outcomesOverall post-discharge outcomes


7/27/10 – 10/2/12

N

Total 196

Indications Uterine cancer Ovarian cancer Cervical cancer Non-gyn cancer indications

81 (40%)8 (4%)5 (2%)

102 (55%)

Procedures TLH +/-BSO TLH +/-BSO +SLN TLH +/-BSO +PLND TLH +/-BSO +PLPALND TLH +/-BSO +PLPALND +SLN TLH +/-BSO +PLPALND +oment TLH +/-BSO +PLPALND +oment +appy TLH +/-BSO +oment TLH +/-BSO +PALND TLH +/-BSO +PALND +oment +SLN PLPALND PALND PLPALND +omentect +Ipport Trachelectomy (simple) + BSO Debulking

102 (53%)58 (29%)

4 (2%)9 (6%)4 (1%)2 (2%)1 (1%)4 (2%)1 (1%)2 (1%)2 (1%)1 (1%)2 (1%)3 (2%)1 (1%)

Robotics at MSKCCRobotics at MSKCCSame day dischargeSame day discharge

7/27/10 –10/2/12

N

Total 196

Stayed overnightReasons Long commute Patient “wanted” Weather Late case Pain Nausea/HA Nausea/fever Emesis on emergence Urinary retention Abnormal EKG Intraop vaginal laceration Intraop cystotomy Pre- and/or postop vasovagal episodes Minilap to remove specimen Postop hypoxemia

42 (22%)

2101544114131221

Readmitted – totalReadmitted – went homeReadmitted – stayed o/n Pelvic hematoma Retained foreign object (driver cover) Abd wall hematoma Ventral (non-trocar) hernia

4/196 (2.1%)2/154 (1.3%)2/42 (4.8%)

1111

Robotics at MSKCCRobotics at MSKCCSame day hysterectomySame day hysterectomy

1. Provide a more accurate identification of tumor drainage

2. May avoid total lymphadenectomy

3. Decrease the risk of leg lymphedema, symptomatic lymphocysts, nerve injury, vascular injury and VTE

4. Provide for pathologic ultra staging analysis

5. Potential application in fertility-sparing surgery

Sentinel Lymph Node (SLN) Mapping in Endometrial Cancer

Robotic Fluorescence for Robotic Fluorescence for Sentinel Node MappingSentinel Node Mapping

CharacteristicLSC/RBT*Blue dye

RBT **ICG

P-value

NSuccessful SLN mapping – by patientBilateral pelvic mapping

270224 (83%)133 (49%)

125123 (98%)105 (84%)

<0.0005<0.0005

SLN mappingSLN mappingMSK experienceMSK experience

Disadvantages of Robotics?

• Learning Curve of New Technology

• Docking Time

• Cost

RoboticsRoboticsConversion ratesConversion rates

5/15/07-12/31/11 18.8% 15.8% 9.1% 7.4%

0

100

200

300

400

500

600

700

2007 2008 2009 2010 2011

5.7%

ResultsRobotic learning curve

COMPLETED Uterine cancer cases (310 RBT/263 LSC) - 5/07 - 12/31/10 (44 months)Median total room time


N 111 80 51 36 20 20 20 9

Median time (min) 350 310 267 266 232 247 211 241

Range 186-613 194-548 189-445 197-377 142-400 177-353 169-315 205-335

P<0.001

LRS = 250 min

ResultsRobotic learning curve

COMPLETED Uterine cancer cases (310 RBT/263 LSC) - 5/07 - 12/31/10 (44 months)Median operative time


P<0.001

LRS = 184 min

N 111 80 51 36 20 20 20 9

Median time (min) 267 227 193 176 164 152 145 163

Range 131-533 126-476 124-348 115-266 120-307 99-272 96-224 122-215

5/1/07 – 12/31/10 LSC RBT P-value

Hysterectomy only* N Total room time (min) Total skin-skin time (min)

24222 (135-380)152 (80-308)

32225.5 (142-512)

147 (99-440)0.40.9

SLN algorithm** N Total room time (min) Total skin-skin time (min)

120205.5 (128-415)

147 (85-322)

117254 (169-465)172 (96-334)

<0.001<0.001

PLPALND N Total room time (min) Total skin-skin time (min)

119300 (203-532)231 (128-445)

71312 (214-548)228 (157-476)

0.020.4

Times are reported as medians (ranges) for completed uterine cancer cases*Few hyst only cases – these data represent all RBT case and do not exclude first 20**Variable extent of selective LND and SLN introduced in RBT in mid 2009

Learning curveLearning curveTimes after first 20 robot casesTimes after first 20 robot cases


Robotics Learning CurveRobotics Learning CurveMedian docking time (min)Median docking time (min)

Robotics Costs

• Current cost analyses are based modeling and do not provide direct cost comparisons

• The greatest contribution to cost is the OR time • OR time is always longer when first learning

something new• Analyses compare early learning of robotics to

≥10-20 years of laparoscopic experience of often low volume robotic surgeons

• Higher volume more experienced centers result in lower costs

Robotics Points to consider about cost comparison

• Assess after robotic learning curve achieved • Compare costs of care of patients before and after

robotics introduced efficiently into practice (not just LRS vs RBT) – OR times equalize after learning curve– OR times better than LRS for many surgeons– More cases are done minimally invasive leading to all the

proven benefits of MIS being realized in greater number of patients

– Shorter LOS results in greater free inpatient beds to bring in more surgical volume

• Forget RBT vs OPEN comparisons – irrelevant• Costs decrease for technology over time and with

increasing competition• What are costs of drugs we use to improve PFS/OS

only by 2-4 months?

Jonsdottir GM, et al. Obstet Gynecol 2011;117:1142-1149

CostsImpact of increasing MIS approach

Jonsdottir GM, et al. Obstet Gynecol 2011;117:1142-1149

CostsImpact of increasing MIS approach

Indirect societal cost estimates for 2009

Abdominal Vaginal LSCRBT

$17,671-$18,065$15,631-$16,419$14,826-$15,483$13,501-$14,158

Wright JD, et al. J Clin Oncol 2012;30:783-791

CostsPopulation-based analysis of RBT vs LRS

• PERSPECTIVE DATABASE• Voluntary, fee-supported database• Samples >500 acute care hospitals • Submit data on inpatient admissions• Represents approximately 15% of nationwide

hospitalizations


CostsPopulation-based analysis of RBT vs LRS

A different “PERSPECTIVE”A review of inexperienced MIS/RBT surgeons


A different “PERSPECTIVE”More complex cases done with RBT?


A different “PERSPECTIVE”Effect of surgeons on early learning curve on

cost?


<9 cases per year >14 cases per year

45% decrease in cost!!

Cancer RegimensPFS

(mos)OS

(mos)Δ

(mos)Costs

(approx.)

Colon(N=923)

Lung(N=731)

Lung maintain(N=889)

Melanoma(N=502)

Ovary (recur)(N=484)

Breast - early(pooled)

IFL + bevIFL

ErlotinibBSC

ErlotinibPlacebo

Dacarbazine + IpilimumabDacarbazine + placebo

Gem/carbo + bevGem/Carbo + placebo

TrastuzumabNon-trastuzumab

10.66.2

12.48.4

20.315.6

6.74.7

12.3 wks11.1 wks

11.29.1

33.3*35.2*

mortality6%

8.5%

+4.7

+3.0

+1.2 wks

+2.1

+4.0 (pfs)-1.9 (os)*

$5000/doseq3wks

$3300/monthqd dosing

$30,000/doseX4

$5000/doseq3wks

$2600/doseq3wk x 17

““AdvancesAdvances”” in cancer in cancer Targeted therapy costsTargeted therapy costs

Conclusions • Prospective controlled trials suggest that Minimally

Invasive Surgical approach is superior for endometrial cancer when feasible: decreased rate of complications, hospital length of stay, equivalent nodal counts and oncologic outcomes

• Retrospective studies demonstrate equivalent excellent outcome for Robotics vs. Standard Laparoscopy

• Benefits of Robotics include increased case eligibility for MIS, increased instrument functionality, less pain, same day surgery, SLN flourescence

• Potential disadvantages: Learning Curve, Docking, Cost

THANK YOU!THANK YOU!

endometrial cancer surgery open vs laparoscopic vs robotic surgery advantages, disadvantages, &...

Documents

j clin oncol

lancet oncol

gynecol oncol

overall survivalgog

laparotomy casesgog

quality of lifegog lap

interquartile rangesgog

median operative time