Financial DisclosureFinancial Disclosure

““As it pertains to CME, I have As it pertains to CME, I have no relevant financial no relevant financial

relationships with any relationships with any commercial interest to commercial interest to

disclose.”disclose.”

Minimally Invasive Surgery in Minimally Invasive Surgery in Gynecologic OncologyGynecologic Oncology

Minimally Invasive Minimally Invasive Surgery in Surgery in

Gynecologic OncologyGynecologic Oncology

William M. Merritt, MDWilliam M. Merritt, MD

April 2010April 2010

ObjectivesObjectives

Reviews types of gynecologic cancer Reviews types of gynecologic cancer and treatmentsand treatments

Minimally Invasive Surgery (MIS)Minimally Invasive Surgery (MIS) Role of MIS in Gynecologic Oncology Role of MIS in Gynecologic Oncology

(and Gynecology)(and Gynecology) Patient benefits and risks with MISPatient benefits and risks with MIS

2009 Estimates on Female 2009 Estimates on Female CancerCancer

020406080

100120140160180200

New Cases Deaths

Th

ou

san

ds

© 2009, American Cancer Society, http://www.cancer.org

Ovarian CancerOvarian Cancer 21,550 estimated new cases in 200921,550 estimated new cases in 2009 Lifetime risk: 1.7%Lifetime risk: 1.7% Average age: 59Average age: 59 Risk Factors: family historyRisk Factors: family history SymptomsSymptoms

– BloatingBloating– Weight gainWeight gain– Abdominal discomfortAbdominal discomfort– Early satiety (feeling full)Early satiety (feeling full)– NauseaNausea

Detection:Detection:– Pelvic examPelvic exam– Imaging (Ultrasound, CT Scan)Imaging (Ultrasound, CT Scan)– Ca-125Ca-125– OVA1 (recently FDA approved)OVA1 (recently FDA approved)

Endometrial/ Uterine CancerEndometrial/ Uterine Cancer Most common gynecologic cancerMost common gynecologic cancer

– 42,160 new cases in 200942,160 new cases in 2009 Risk Factors: obesity, unopposed estrogen, Risk Factors: obesity, unopposed estrogen,

no pregnanciesno pregnancies Symptoms:Symptoms:

– Abnormal uterine bleedingAbnormal uterine bleeding– Bleeding after menopauseBleeding after menopause

Detection:Detection:– Pelvic examPelvic exam– Endometrial biopsyEndometrial biopsy– Pelvic ultrasoundPelvic ultrasound

Endometrioid UPSC/Clear CellPresent in earlier stage

Present with advanced stage

Stage I 73% Stage I 54%

Stage II 11% Stage II 8%

Stage III 13% Stage III 22%

Stage IV 3% Stage IV 16%

5-yr survival 5-yr survival

Stage I 85-90% Stage I 60%

Stage II 70% Stage II 50%

Stage III 40-50% Stage III 20%

Stage IV 15-20% Stage IV 5-10%

Gehrig et al, Gyn Onc 2010

Cervical CancerCervical Cancer 11,270 new cases in the 200911,270 new cases in the 2009 Death rates decreasing due to early detectionDeath rates decreasing due to early detection Risk factors:Risk factors:

– HPV infectionHPV infection– Cigarette smokingCigarette smoking– Sexual activity at an early age (exposure)Sexual activity at an early age (exposure)

Symptoms:Symptoms:– Abnormal vaginal bleedingAbnormal vaginal bleeding– Vaginal dischargeVaginal discharge

Detection:Detection:– Pelvic ExamPelvic Exam– Pap smear / HPV testingPap smear / HPV testing

Vulvar CancerVulvar Cancer Rare: 4% of all gynecologic cancersRare: 4% of all gynecologic cancers Risk factorsRisk factors

– HPVHPV– SmokingSmoking– Skin disorders of the vulvaSkin disorders of the vulva

SymptomsSymptoms– Itching (itch scratch cycle)Itching (itch scratch cycle)– Vulvar mass / ulcerVulvar mass / ulcer– BleedingBleeding

DetectionDetection– Pelvic examPelvic exam– BiopsyBiopsy

TreatmentTreatment

Ovarian cancerOvarian cancer– Surgery + chemotherapySurgery + chemotherapy

Endometrial cancerEndometrial cancer– Surgery Surgery ± radiation (± chemotherapy)± radiation (± chemotherapy)

Cervical cancerCervical cancer– Surgery OR radiation + chemotherapySurgery OR radiation + chemotherapy

Vulvar cancerVulvar cancer– Surgery ± radiationSurgery ± radiation

Vagina

Uterus

Endometrium

MyometriumOvary

Fallopian Tube

Cervix

Vagina

Uterus

Endometrium

MyometriumOvary

Fallopian Tube

Cervix

Surgical OptionsSurgical Options

Traditional: LaparotomyTraditional: Laparotomy

Midline vertical Transverse

Minimally Invasive Surgery Minimally Invasive Surgery (MIS)(MIS)

An approach to surgery whereby An approach to surgery whereby operations are performed with operations are performed with specialized instruments designed to specialized instruments designed to be inserted through small incisions or be inserted through small incisions or natural body openings natural body openings

TypesTypes– LaparoscopicLaparoscopic– RoboticRobotic

What can be done with MISWhat can be done with MIS HysterectomyHysterectomy

– SupracervicalSupracervical– TotalTotal

Tubes and ovariesTubes and ovaries MyomectomyMyomectomy

– Removal of fibroidsRemoval of fibroids Lymph node Lymph node

dissectiondissection– PelvicPelvic– AorticAortic

Diagnostic (looking)Diagnostic (looking)

MIS – What’s so good about it?MIS – What’s so good about it?

Less post-operative painLess post-operative pain Shorter hospital stayShorter hospital stay Less blood lossLess blood loss Quicker return to normal activitiesQuicker return to normal activities Smaller incisionsSmaller incisions

Are there any drawbacks?Are there any drawbacks?

Not all procedures are safe to do with Not all procedures are safe to do with MISMIS

TimeTime– Learning curveLearning curve– Some cases take longer compared to Some cases take longer compared to

traditional approachtraditional approach CostCost

Role of MIS in endometrial Role of MIS in endometrial cancercancer

FeasibilityFeasibility– Is it possible?Is it possible?– Reproducible?Reproducible?

Comparison with standard approachComparison with standard approach– Better, worse, and equivalent?Better, worse, and equivalent?

Risks/BenefitsRisks/Benefits– AcuteAcute– Long termLong term

LaparoscopyLaparoscopy

Laparoscopy vs Laparotomy Laparoscopy vs Laparotomy – GOG LAP2– GOG LAP2

Study Population (1996-2005)Study Population (1996-2005)– L/S: 1,696 L/S: 1,696 Open: 920Open: 920

Conversion rate: 434 (25.8%)Conversion rate: 434 (25.8%)

Surgical StagingSurgical Staging– Lymph node dissectionLymph node dissection

99% (open) vs. 98% (L/S)99% (open) vs. 98% (L/S)– Pelvic/aortic: 96% (open) vs. 92% (L/S)Pelvic/aortic: 96% (open) vs. 92% (L/S)– Aortic: 97% vs. 94%Aortic: 97% vs. 94%

– No difference in patients w/ advance No difference in patients w/ advance surgical stagesurgical stage

Walker et al, JCO 2009

Laparotomy(n=920)

% Laparoscopy(n=1,248)

% P

OR time (min) 130 204 <0.001

Hospital stay >2days

845 94 867 52 <0.001

Complications

-Vascular 29 4 75 5

-Post op fever 33 8 55 3

-Ileus/SBO 80 9 80 5

-Wound infection

33 4 53 3

-Transfusion 66 7 143 9

-Deaths 8 1 10 <1

-Bladder/Bowel

23 3 58 3

Walker et al, JCO 2009

What do the patients think?What do the patients think? L/S (n=535) vs. open (n=267)L/S (n=535) vs. open (n=267) Quality of life (FACT-G)Quality of life (FACT-G)

– EmotionalEmotional– PhysicalPhysical– SocialSocial– Functional well-well beingFunctional well-well being

6 weeks6 weeks– L/S: better physical functioning and body image, less pain, L/S: better physical functioning and body image, less pain,

earlier resumption of normal activities and return to workearlier resumption of normal activities and return to work

6 months6 months– L/S: better body imageL/S: better body image

Kornblith et al, Gyn Onc 2009.

Are there acute benefits?Are there acute benefits?

MIS (L/S and robotic; n=66) vs open (n=115)MIS (L/S and robotic; n=66) vs open (n=115) OR time (min)OR time (min)

– 284 vs 203 284 vs 203 P<0.0001P<0.0001 EBLEBL

– 300 vs 100 mL300 vs 100 mL P<0.0001P<0.0001 Hospital stayHospital stay

– 1 day vs 4 days 1 day vs 4 days P<0.0001P<0.0001 Median narcotic use (24 hr post op)Median narcotic use (24 hr post op)

– 43 mg vs 10 mg (morphine equiv) 43 mg vs 10 mg (morphine equiv) P<0.0001P<0.0001 Nausea – MIS patients required less rescue Nausea – MIS patients required less rescue

antiemetics 24hr pos opantiemetics 24hr pos op

Havrilesky et al, Gyn Onc 2009

Long term cancer benefit?Long term cancer benefit?L/S vs. Open (N)

Follow up(months)

Overall survival

Disease free survival

Cancer-related survival

Tozzi et al63 vs 59 44

82% vs 86% 87% vs 92% 25% (2/8) vs 40% (2/5)

Zullo et al40 vs 38 79

82% vs 84% 80% vs 82% 50% (4/8) vs 44% (4/7)

Malzoni et al

81 vs 78 38.5??? ??? ???

Tozzi et al, J Minim Invasive Gynecol 2005Zullo et al, Am J Obstet Gynecol 2009Malzoni et al, Gyn Onc 2009

• No difference in survival recently reported for GOG LAP2 trial at 3-yr follow up

Cervical cancerCervical cancerNo. pts OR time

(min)EBL (mL) Hosp. stay

(d)Margins Complications

Spirtos et al.All L/S

78 205 225 NR All negative

3 cystotomies1 ureterovaginal fistula

Abu-Rustum et al.L/S vs. open

17 vs. 195

371 vs. 295

301 vs. 693

4.5 vs. 9.7 NR No ureteral injuries or fistulas reported

Frumovitz et al.L/S vs. open

35 vs. 54 344 vs. 307

319 vs. 548

2 vs. 5 All negative

- 18% vs. 53% infectious morbidities- No noninfectious reported

Spirtos et al, AJOG 2002Abu-Rustum et al, Gyn Onc 2003Frumovitz et al, Obstet Gynec 2007

• No difference in recurrence or survival reported

NR = not reported

Robotic Surgery – What it isn’t…Robotic Surgery – What it isn’t…

Robotic Surgery- What it is…Robotic Surgery- What it is…

Robotic SurgeryRobotic Surgery da Vincida Vinci robot system is the only robotic surgical robot system is the only robotic surgical

system is use todaysystem is use today BenefitsBenefits

– Improved visual fieldsImproved visual fields– Less dependence on surgical assistanceLess dependence on surgical assistance– Surgeon comfortSurgeon comfort– Increased instrument mobilityIncreased instrument mobility

DrawbacksDrawbacks– CostCost– Loss of tactile feedbackLoss of tactile feedback– Learning curveLearning curve– AvailabilityAvailability– Bulky machineBulky machine– Trochar sizeTrochar size

Set-upSet-up

Set-upSet-up

Set-up

Robotic InstrumentsRobotic Instruments

Instruments are controlled by the surgeon’s hands

High range of motion for robotic instruments allow for addressing complex surgical

issues

Comparison of 3 methods:Comparison of 3 methods:open, L/S, roboticopen, L/S, robotic

Open (n=138), L/S (n=81), & robotic (n=103)Open (n=138), L/S (n=81), & robotic (n=103) OR time: L/S (213 min) > robot (191) > open (147)OR time: L/S (213 min) > robot (191) > open (147) RobotRobot

– Better lymph node countBetter lymph node count– Lower EBL 75 mLLower EBL 75 mL– Lower hospital stay (1 day)Lower hospital stay (1 day)

Complication rate: Robot (6%) vs. open (30%)Complication rate: Robot (6%) vs. open (30%) Conversion rate: L/S (5%) & robot (3%)Conversion rate: L/S (5%) & robot (3%) No long term follow up reportedNo long term follow up reported

Boggess et al, AJOG 2009

Is robotic surgery better Is robotic surgery better than laparoscopy?than laparoscopy?

Robot assisted Laparoscopy

OR time (min) 2621

1692

1923

2061

1413

EBL (mL) 509749

100

105

Hospital stay (days) 11.61

2

1

1. Leitao et al, Gyn Onc 20092. Lowe et al, Gyn Onc 20093. Nevadunsky et al, Gyn Onc 20094. Mendivil et al, Gyn Onc 2009

No difference in survival at 40 months (n=141)4

Robotics and cervical cancerRobotics and cervical cancer No. patients EBL (mL) OR time

(min)Hosp. stay (min)

Kim et al 10 207 355 7.9

Fanning et al 20 300 390 1

Sert et alRobot vs. L/S

7 vs. 7 71 vs. 160 241 vs. 3000 4 vs. 8

Nezhat et al.Robot vs. L/S

13 vs. 30 157 vs. 200 323 vs. 318 2.7 vs. 3.8

Boggess et alRobot vs. LAP

51 vs. 49 97 vs. 417 211 vs. 248 1 vs. 3.2

Kim et al, Gyn Onc 2008Fanning et al, AJOG 2008Sert et al, Int J Med Robot 2007Nezhat et al, JSLS 2008Boggess et al, AJOG 2008

Fertility preservation?Fertility preservation?

Laparotomy / vaginal approachLaparotomy / vaginal approach– Traditional approachTraditional approach

OR time: 163 to 253 minOR time: 163 to 253 min

– Recurrence rates: 2.7 to 7.3%Recurrence rates: 2.7 to 7.3%– Pregnancy (delivery >37 weeks) 60%Pregnancy (delivery >37 weeks) 60%

Robotic approachRobotic approach– 4 studies (8 pts total)4 studies (8 pts total)

OR time – 172 to 373 minOR time – 172 to 373 min EBL (mL) – 62 to 200EBL (mL) – 62 to 200 Hosp stay (d) – 1.5 to 3.5Hosp stay (d) – 1.5 to 3.5 Complications: 2 (edema & neuropathy)Complications: 2 (edema & neuropathy) F/U: no recurrence in 105 d F/U: no recurrence in 105 d (Ramirez et al , (Ramirez et al , Gyn Onc Gyn Onc 2010) 2010)

No pregnancies reported to dateNo pregnancies reported to dateDursun et al, EJSO 2007Ramirez et al, Gyn Onc 2008Ramirez et al, Gyn Onc 2010

Suturing During HysterectomySuturing During Hysterectomy

Conclusions

MIS surgery is a reasonable option in gynecologic cancer– Endometrial– Cervical– Ovary (early stage)

Laparotomy, laparoscopy and robotic surgery offer advantages for patients short term but are equivalent in patient survival

Robotic surgery offers surgeon advantages over laparoscopy