1. Minimally Invasive Surgery in Gynecologic Oncology
Financial Disclosure
“As it pertains to CME, I have no relevant financial relationships with any commercial interest to disclose.”

2. Minimally Invasive Surgery in Gynecologic Oncology
William M. Merritt, MD
April 2010
I would like to thank ____________ for this opportunity to speak at this months “For Women’s Only” series. Since moving back to Columbia from Houston, My wife and I truly feel like we are back home here in South Carolina. Today’s topic is an important one in medicine today, not only in cancer, but in our field of women’s care.

3. Objectives Reviews types of gynecologic cancer and treatments
Minimally Invasive Surgery (MIS)
Role of MIS in Gynecologic Oncology (and Gynecology)
Patient benefits and risks with MIS
Throughout the next 30 minutes I hope to provide you with information that will be helpful for you or your loved ones in understanding where our field is today in cancer care. First I will review the most common Gynecologic cancers we provide care for. Next, I will discuss the topic of MIS and more specifically the different types and there role in gynecologic cancer conditions, as well as some benign (non-cancerous) conditions. Lastly, I have prepared some slide with commonly asked questions that I hope will be informative. Following I know we will have time to discuss any additional questions that you have but please feel free to raise your hand or stop me at any point to ask a question. I would like to keep this as informal as possible.

4. 2009 Estimates on Female Cancer
Thousands
© 2009, American Cancer Society,

5. Ovarian Cancer 21,550 estimated new cases in 2009 Lifetime risk: 1.7%
Average age: 59
Risk Factors: family history
Symptoms
Bloating
Weight gain
Abdominal discomfort
Early satiety (feeling full)
Nausea
Detection:
Pelvic exam
Imaging (Ultrasound, CT Scan)
Ca-125
OVA1 (recently FDA approved)
Ovarian cancer is second most common gynecologic cancer today and continues to be one of the most difficult to treat. The lifetime risk of developing ovarian cancer is 1.7%; however women with strong family history of ovary and/or breast cancer may have an increased risk due to genetics. Symptoms for ovarian cancer are generally nonspecific. When you interview women with ovarian cancer you will often hear that these type of symptoms have been occuring daily for several weeks and are/were different from their normal self. There are no good screening tests for this disease but using combination of exam, U/S, and ca-125 testing will help with diagnosis for certain patients.

6. Endometrial/ Uterine Cancer
Most common gynecologic cancer
42,160 new cases in 2009
Risk Factors: obesity, unopposed estrogen, no pregnancies
Symptoms:
Abnormal uterine bleeding
Bleeding after menopause
Detection:
Pelvic exam
Endometrial biopsy
Pelvic ultrasound
Endometrial or uterine cancer is the most common gynecologic cancer in the US and SC. Fortunately it is also very curable due to early detection. We know that women who have unopposed estrogen, that is not enough or no progesterone to the uterus are at high risk. HRT therapy has evolved to eliminate this possibility but unfortunately one of the main producers of estrogen is fat cells – hence obesity being a major risk factor. Women with AUB generally are evaluated with either a biopsy of U/S to confirm diagnosis.

7. Endometrioid UPSC/Clear Cell Present in earlier stage
Present with advanced stage
Stage I
73%
54%
Stage II
11% 8%
Stage III
13%
22%
Stage IV 3%
16%
5-yr survival
85-90%
60%
70%
50%
40-50%
20%
15-20%
5-10%
Gehrig et al, Gyn Onc 2010

8. Cervical Cancer 11,270 new cases in the 2009
Death rates decreasing due to early detection
Risk factors:
HPV infection
Cigarette smoking
Sexual activity at an early age (exposure)
Symptoms:
Abnormal vaginal bleeding
Vaginal discharge
Detection:
Pelvic Exam
Pap smear / HPV testing
Cervical cancer is not nearly as common as it used to be thanks to PAP smears. Early detection of precancerous cells has led to a significant delice in new cases and in turn deaths due to ovarian cancer. With the introduction of HPV (or Human Papilloma Virus) testing – early detection and screening methods continue to improve. Not to head off on to far of a tangent – many of you may have heard of the HPV vaccine. I truly feel like the jury is still out on this. I can discuss this more later if you want.

9. Vulvar Cancer Rare: 4% of all gynecologic cancers Risk factors
HPV
Smoking
Skin disorders of the vulva
Symptoms
Itching (itch scratch cycle)
Vulvar mass / ulcer
Bleeding
Detection
Pelvic exam
Biopsy
Vulvar cancer is even rarer than cervical cancer. Similar risk factors exist as for cervical cancer. Patients typically describe vulvar itching and bleeding. Diagnosis is made by biopsy.

10. Treatment Ovarian cancer Endometrial cancer Cervical cancer
Surgery + chemotherapy
Endometrial cancer
Surgery ± radiation (± chemotherapy)
Cervical cancer
Surgery OR radiation + chemotherapy
Vulvar cancer
Surgery ± radiation
Vagina
Uterus
Endometrium
Myometrium
Ovary
Fallopian Tube
Cervix
Vagina
Uterus
Endometrium
Myometrium
Ovary
Fallopian Tube
Cervix
Treatment for each of these cancers differs widely. This is mainly due to disease process itself. Ovarian cancer spreads like leaves off a tree. Goal at the time of surgery is take out all the visible cancer possible. Unfortunately, most patients that are diagnosed with ovarian cancer have disease already outside of the ovaries. For this reason, there is very little role for MIS. In a few cases, ovarian cancer is diagnosed in the early stage, i.e. confined to the ovary and these patients may be candidates for staging with MIS.
Endometrial cancer spreads into the uterus, through the bloodstream and lymphatics. At the time of surgery, a hysterectomy with removal of tubes and ovaries are perfomed. In addition, staging procedures including removal of lymph nodes in the pelvis and abdomen maybe performed based on the tumor itself.
Cervical cancer spreads by local extension, i.e. it invades tissue next to the cervix. It can also spread to lymph nodes. Upon diagnosis, patients are deemed surgical candidates based on size and stage of cancer. If surgery, then either a simple hysterectomy or radical hysterectomy is performed. Radical differs in that……
Vulvar cancer is treated typically by surgical resection of the tumor and regional lymph nodes. Patients may need additional therapy following in the form of XRT.

11. Surgical Options Traditional: Laparotomy Midline vertical Transverse
So when patients go to the OR for cancer surgery, the traditional approach was to make a large incision. Usually either an up and down or low transverse incision was made. For most cancer cases, the vertical incision is preferred due to allowing access to the upper abdomen for exploration.
Midline vertical
Transverse

12. Minimally Invasive Surgery (MIS)
An approach to surgery whereby operations are performed with specialized instruments designed to be inserted through small incisions or natural body openings
Types
Laparoscopic
Robotic
Over the past 15 years MIS has become a large part of surgical therapy not only in our field but others as well. MIS in a nut shell is defined as …….
Two types used in our specialty include.

13. What can be done with MIS
Hysterectomy
Supracervical
Total
Tubes and ovaries
Myomectomy
Removal of fibroids
Lymph node dissection
Pelvic
Aortic
Diagnostic (looking)

14. MIS – What’s so good about it?
Less post-operative pain
Shorter hospital stay
Less blood loss
Quicker return to normal activities
Smaller incisions

15. Are there any drawbacks?
Not all procedures are safe to do with MIS
Time
Learning curve
Some cases take longer compared to traditional approach
Cost

16. Role of MIS in endometrial cancer
Feasibility
Is it possible?
Reproducible?
Comparison with standard approach
Better, worse, and equivalent?
Risks/Benefits
Acute
Long term

17. Laparoscopy

18. Laparoscopy vs Laparotomy – GOG LAP2
Study Population ( )
L/S: 1,696 Open: 920
Conversion rate: 434 (25.8%)
Surgical Staging
Lymph node dissection
99% (open) vs. 98% (L/S)
Pelvic/aortic: 96% (open) vs. 92% (L/S)
Aortic: 97% vs. 94%
No difference in patients w/ advance surgical stage
Walker et al, JCO 2009

19. Hospital stay >2days 845 94 867 52
Laparotomy
(n=920) %
Laparoscopy
(n=1,248) P
OR time (min)
130
204
<0.001
Hospital stay >2days
845 94
867 52
Complications
-Vascular 29 4 75 5
-Post op fever 33 8 55 3
-Ileus/SBO 80 9
-Wound infection 53
-Transfusion 66 7
143
-Deaths 1 10
<1
-Bladder/Bowel 23 58
Walker et al, JCO 2009

20. What do the patients think?
L/S (n=535) vs. open (n=267)
Quality of life (FACT-G)
Emotional
Physical
Social
Functional well-well being
6 weeks
L/S: better physical functioning and body image, less pain, earlier resumption of normal activities and return to work
6 months
L/S: better body image
Kornblith et al, Gyn Onc 2009.

21. Are there acute benefits?
MIS (L/S and robotic; n=66) vs open (n=115)
OR time (min)
284 vs 203 P<0.0001
EBL
300 vs 100 mL P<0.0001
Hospital stay
1 day vs 4 days P<0.0001
Median narcotic use (24 hr post op)
43 mg vs 10 mg (morphine equiv) P<0.0001
Nausea – MIS patients required less rescue antiemetics 24hr pos op
Havrilesky et al, Gyn Onc 2009

22. Long term cancer benefit?
L/S vs. Open
(N)
Follow up
(months)
Overall survival
Disease free survival
Cancer-related survival
Tozzi et al
63 vs 59 44
82% vs 86%
87% vs 92%
25% (2/8) vs 40% (2/5)
Zullo et al
40 vs 38 79
82% vs 84%
80% vs 82%
50% (4/8) vs 44% (4/7)
Malzoni et al
81 vs 78
38.5
???
No difference in survival recently reported for GOG LAP2 trial at 3-yr follow up
Tozzi et al, J Minim Invasive Gynecol 2005
Zullo et al, Am J Obstet Gynecol 2009
Malzoni et al, Gyn Onc 2009

23. Cervical cancer No difference in recurrence or survival reported
No. pts
OR time
(min)
EBL (mL)
Hosp. stay (d)
Margins
Complications
Spirtos et al.
All L/S 78
205
225 NR
All negative
3 cystotomies
1 ureterovaginal fistula
Abu-Rustum et al.
L/S vs. open
17 vs. 195
371 vs. 295
301 vs. 693
4.5 vs. 9.7
No ureteral injuries or fistulas reported
Frumovitz et al.
35 vs. 54
344 vs. 307
319 vs. 548
2 vs. 5
- 18% vs. 53% infectious morbidities
- No noninfectious reported
NR = not reported
No difference in recurrence or survival reported
Spirtos et al, AJOG 2002
Abu-Rustum et al, Gyn Onc 2003
Frumovitz et al, Obstet Gynec 2007

24. Robotic Surgery – What it isn’t…

25. Robotic Surgery- What it is…

26. Robotic Surgery
da Vinci robot system is the only robotic surgical system is use today
Benefits
Improved visual fields
Less dependence on surgical assistance
Surgeon comfort
Increased instrument mobility
Drawbacks
Cost
Loss of tactile feedback
Learning curve
Availability
Bulky machine
Trochar size

27. Set-up

28. Set-up

29. Set-up

30. Instruments are controlled by the surgeon’s hands
Robotic Instruments
Instruments are controlled by the surgeon’s hands
High range of motion for robotic instruments allow for addressing complex surgical issues

31. Comparison of 3 methods: open, L/S, robotic
Open (n=138), L/S (n=81), & robotic (n=103)
OR time: L/S (213 min) > robot (191) > open (147)
Robot
Better lymph node count
Lower EBL 75 mL
Lower hospital stay (1 day)
Complication rate: Robot (6%) vs. open (30%)
Conversion rate: L/S (5%) & robot (3%)
No long term follow up reported
Boggess et al, AJOG 2009

32. Is robotic surgery better than laparoscopy?
Robot assisted
Laparoscopy
OR time (min)
2621
1692
1923
2061
1413
EBL (mL) 50 97 49
100
105
Hospital stay (days) 1
1.6 2
No difference in survival at 40 months (n=141)4
1. Leitao et al, Gyn Onc 2009
Lowe et al, Gyn Onc 2009
Nevadunsky et al, Gyn Onc 2009
Mendivil et al, Gyn Onc 2009

33. Robotics 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 al
Robot vs. L/S
7 vs. 7
71 vs. 160
241 vs. 3000
4 vs. 8
Nezhat et al.
13 vs. 30
157 vs. 200
323 vs. 318
2.7 vs. 3.8
Boggess et al
Robot vs. LAP
51 vs. 49
97 vs. 417
211 vs. 248
1 vs. 3.2
Kim et al, Gyn Onc 2008
Fanning et al, AJOG 2008
Sert et al, Int J Med Robot 2007
Nezhat et al, JSLS 2008
Boggess et al, AJOG 2008

34. Fertility preservation?
Laparotomy / vaginal approach
Traditional approach
OR time: 163 to 253 min
Recurrence rates: 2.7 to 7.3%
Pregnancy (delivery >37 weeks) 60%
Robotic approach
4 studies (8 pts total)
OR time – 172 to 373 min
EBL (mL) – 62 to 200
Hosp stay (d) – 1.5 to 3.5
Complications: 2 (edema & neuropathy)
F/U: no recurrence in 105 d (Ramirez et al , Gyn Onc 2010)
No pregnancies reported to date
Dursun et al, EJSO 2007
Ramirez et al, Gyn Onc 2008
Ramirez et al, Gyn Onc 2010

36. Suturing During Hysterectomy

37. 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