Laparoscopic Radical Trachelectomy in Early Cervical Cancer

Suk-Joon Chang, MD, PhD Director, Division of Gynecologic Oncology

Professor, Department of Obstetrics and Gynecology Ajou University School of Medicine, Suwon, Korea

6th ASM OGSHK and Ovarian Club VII Hong Kong Hong Kong Convention and Exhibition Centre

21-22 May, 2016

Disclosure

No relevant conflict of interests to disclose

Case Presentation

• 32 year old G0 with postcoital bleeding, CIN 3

• Medical-Surgical Hx: Negative • OBGYN Hx: Normal menses • Pelvic exam: Erosive cervix, no mass lesion Adnexa normal

• LEEP conization: Invasive SCC, > 5mm invasion with 9mm extension, margins +

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Pretreatment Evaluation

• No parametrial invasion • No LN metastasis • No distant metastasis

• FIGO stage IB1

“What would be your recommendation for this patient?”

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2016 NCCN Guidelines

• If the patient does not want fertility preservation,

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Traditional treatment of early stage cervical cancer beyond microinvasion

Radical hysterectomy + pelvic lymphadenectomy

+/- para-aortic lymphadenectomy or

CCRT

Loss of fertility

Background

• QoL and fertility preservation are critical issues for cancer survivors, especially reproductive-age patients.

• 42% of cervical cancer are under the age of 45 years who are potentially interested in a fertility-preserving surgery.

• Traditional forms of treatment eliminate the opportunity for child bearing

Plante M, Int J Gynecol Cancer (2013)

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Spread of Cervical Cancer

• Laterally (dominant) → parametrium

• Vertically (rare) – Stage IB and IIA → 0% – Stage IIB → 20%

Burghardt E and Holzer E, Obstet Gynecol (1977); Ungar L et al, BJOG (2005); Lintner B et al, Int J Gynecol Cancer (2013)

2016 NCCN Guidelines

• If the patient wants fertility preservation,

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Radical Trachelectomy in Early Cervical Cancer

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Radical trachelectomy is a curative conservative procedure to remove the cervix, upper 1-2 cm of the vagina, parametria (tissue adjacent to the cervix), and paracolpos while preserving the uterine corpus and fundus

In 1986, Prof. Daniel Dargent 1st undertook fertility-sparing surgery - laparoscopic pelvic LND and vaginal radical trachelectomy also referred to as the “Dargent operation”.

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Dargent D, Brun JL, Roy M, Mathevet P. La trachelectomie élargie: uné alternative á l’hystérectomie. Radicale dansu

traitment des cancers in filtrants. JOBGYN. 1994;2:285–292.

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Dividing the uterus after preparation of the specimen Isthmo-vaginal anastomosis after radical trachelectomy

Radical Trachelectomy

• Type – Vaginal radical trachelectomy (VRT) – Abdominal radical trachelectomy (ART) – Laparoscopic radical trachelectomy (LRT) – Robotic radical trachelectomy (RRT)

• The oncologic outcomes between radical hysterectomy and radical trachelectomy for similar-size lesions appear to be comparable.

Generally Accepted Selection Criteria for RT

• Patient who desires preservation of fertility • Age < 40 years • Stage IA1 with LVSI, IA2, small IB1 (≤ 2cm) • Limited endocervical extension

– Preoperative MRI : normal residual cervix above the level of the lesion to clear a safe margin

• No high-risk histology (eg, neuroendocrine tumor) • Negative pelvic nodes

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However, risk factors for recurrence and guideline for adjuvant therapy to decrease recurrence is not established yet.

Vaginal Radical Trachelectomy (VRT)

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Oncologic Outcome - VRT

• 10% abandoned cases : LN + on frozen section, endocervical margin + • 5% adjuvant therapy : risk factors on final pathology • Complications

–5.7% intraoperative complications –postoperative complications (bladder function, lymphocele...) –specific problems related to the trachelectomy procedure (dyspareunia, dysmenorrhea, cervical stenosis, menstrual abnormalities, chronic discharge)

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n Fertility Not Preserved Recurrences DeathsLanowska et al (2011) 225 13 (6%) 8 (3.8%) 4 (1.9%)

Shepherd et al (2012) 208 24 (11.5%) 8 (3.8%) 5 (2.4%)

Covens et al (2013) 180 17 (9.4%) 9 (2.7%) 2 (1.1%)

Plante et al (2011) 140 15 (10.7%) 6 (4.8%) 2 (1.6%)

Marchiole et al (2007) 135 17 (12.6%) 7 (5.7%) 5 (4.2%)

Kim et al (2012) 51 9 (17.6%) 2 (3.9%) 1 (1.9%)

Total 924 95 (10.2%) 40 (4.4%) 19 (2.1%)

Obstetric Outcome - VRT

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n T1 T2 T3 < 32wk 32-36.6wk > 37wk

Shepherd et al (2012) 125 27 (22%) 18 (14%) 73 (58%) 14 (11%) 26 (21%) 33 (26%) 45%

Plante et al (2011) 106 21 (20%) 3 (3%) 77 (73%) 4 (4%) 15 (14%) 58 (55%) 75%

Covens et al (2013) 86 14 (16%) 7 (8%) 65 (76%) 11 (13%) 11 (13%) 43 (50%) 66%

Speiser et al (2011) 60 5 (8%) 3 (5%) 45 (75%) 12 (20%) 6 (10%) 27 (45%) 60%

Mathevet et al (2003) 56 9 (16%) 8 (14%) 34 (61%) 2 (4%) 3 (5%) 29 (52%) 85%

Kim et al (2012) 19 1 (5%) 0 15 (78%) 0 6 (31%) 9 (47%) 60%

Total 452 77 (17%) 39 (8.6%) 309 (68%) 43 (9.5%) 67 (15%) 199 (44%) 64%

The percentage in red represents the percentage of term delivery of patients reaching the third trimester.

Abdominal Radical Trachelectomy (ART)

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Advantages - ART

• Familiar route – short learning curve – minimal additional training

• No special instrumentation • Patients with distorted vaginal anatomy • Pediatric patients • Bulky exophytic lesions • Increased radicality

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Clinical Outcomes - ART

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n Fertility Not Preserved Recurrences No. Pregnant/No. Attempting

Wethington et al (2012) 101 30 (30%) 4 (4%) 28/38 (74%)

Nishio et al (2009) 71 10 (14%) 6 (10%) 4/29 (14%)

Li et al (2011) 64 12 (19%) 0 2/10 (20%)

Muraji et al (2012) 23 3 (13%) 0 1/10 (10%)

Saso et al (2012) 30 0 3 (10%) 3/10 (30%)

Pareja et al (2008) 15 1 (6%) 0 3/6 (50%)

Ungar et al (2005) 33 3 (10%) 0 3/10 (30%)

Total 337 59 (17%) 13 (3.7%) 44/113 (39%)

Laparoscopic Radical Trachelectomy (LRT)

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LRT

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• Adapted from the laparoscopic radical hysterectomy technique.

• Variations in the technique – entire procedure laparoscopically – parts of the surgery laparoscopically and the rest vaginally

• Requires expert laparoscopic skills and adequate instrumentation.

LRT

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n Fertility Not Preserved Recurrences No. Pregnant/No. Attempting

Park et al (2012) 71 9 (13%) 7 (10%)

Kim et al (2010) 27 6 (22%) 1 (4.5%) 3/6

Chen et al (2008) 16 1 (6%) 0 5/?0

Hong et al (2011) 3 1 0 0

Cibula et al (2005) 1 0 0 0

Lee et al (2003) 2 0 0 0

Total 120 17 (14%) 9 (7%) 8

Robotic Radical Trachelectomy (RRT)

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RRT

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n Fertility Not Preserved Recurrences No. Pregnant/No. Attempting

Nick et al (2012) 12 4 0 1

Persson et al (2012) 13 2 0 4/5

Hong et al (2011) 3 0 0 0

Burnett et al (2009) 6 1 0 0

Geisler et al (2008) 1 0 0 0

Chuang et al (2008) 1 0 0 0

Total 36 7 (19%) 0 5

Experience on Laparoscopic Radical Trachelectomy (2004~2013)

Ajou University Hospital and Asan Medical Center

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Our LRT techniques• Combining total LRT and laparoscopy-assisted VRT, which

consists of 70% laparoscopic and 30% vaginal approaches preserving uterine artery

• Advantages – Both laparoscopic and vaginal merits – Direct vision on tumor – Help determine the level of cut – Shorter time for reanastomosis – More convenient & complete dissection of ureter/parametrium – More favorable restoration of reproductive function due to

preservation of the uterine artery

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Chang SJ et al, Gynecol Oncol (2012); Park JY et al, J Surg Oncol (2013)

Uterine artery-preserving LRT

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Chang SJ et al, Gynecol Oncol (2012)

Patients

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88 LRT trial

9 converted to LRH; Intraop frozen biopsy

revealed LNM or PM invasion.

79 completed LRT

78 Laparoscopy only

3 recur 9 recur

1 conversion to laparotpmy

because of IVC injury

Basic characteristics

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N = 79Age, yr (range) 31 (20-40)BMI, kg/cm2 (range) 20.8 (16.7-31.6)Preoperative LEEP or knife conization 47 (60)FIGO stage IA2 4 (5.1) IB1 72 (91.1) IB2 2 (2.5) IIA1 1 (1.3)Tumor > 2cm 29 (36.7)Histology SCC 60 (75.9) AC 18 (22.8) ASC 1 (1.3)LVSI + 12 (15.2)Parametrial invasion + 3 (3.8)LN metastasis + 3 (3.8)

Main clinical outcomes• Operation time: 291 min (120-710) • Estimated blood loss: 393 mL (50-1,500) • Perioperative complications

– Fever: 2 (2.5%) – Ureteral injury & IVC injury: 1 (1.3%) – Vesicovaginal fistula: 1 (1.3%)

• Median duration of follow-up: 44 months (3-105) • 9 patients received adjuvant chemotherapy

– 3-6 cycles of chemo with paclitaxel/platinum • Recurrence: 9/79 (11%) • Cancer-related death: 1/79 (1.3%)

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Disease-free survival

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all 79 patients

Tumor ≤2cm

Tumor >2cm

5 year DFS : 84% P=0.039

Overall survival

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all 79 patients

Tumor ≤2cm

Tumor >2cm

5 year DFS : 98% P=0.429

Factors associated with DFS

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Pregnancy Outcomes

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18 patients tried to conceive (5 received ART)

10 patients succeeded in 14 pregnancies

4 abortions 6 preterm birth 4 term birth

Pregnancy rate = 55.6%

Reports on LRT

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Author (year)

No of cases

Age (yrs.)

FIGO Stage SCC AC or

ASCTumor

Size, cm LVSIMedian

FU, months

1st Trimester

Loss

2nd Trimester

Loss

Preterm Birth

Term Birth

Recur Rate

Death rate

Pomel et al. (2002)

7 NR NR NR NR NR NR NR NR NR NR NR NR NR

Lee et al. (2003)

2 30,34 IB1, IB1 2 0 2.5,NR 1 12,9 NR NR NR NR 0 0

Cibula et al. (2005)

1 36 IB1 1 0 0.8 NR 4 NR NR NR NR 0 0

Bafghi et al. (2006)

6 30 IA2-IB1 NR NR NR 1 25 1 0 0 1 1 1

Kim et al. (2009) 32 29

(22-37) IB1-IIA 20 7 1.7 (0.4-3.5) 0 31

(1-58) 2 0 1 0 1 1

Park et al. (2009)

4 29 IA2-IB1 4 0 NR NR 34 NR NR NR NR NR NR

Martin et al. (2010)

9 32 IA2-IB1 6 3 0.5-2.5 NR 28 (6-32)

0 0 0 2 1 0

Wang et al. (2011)

1 30 IA2 1 0 0.35 0 14 NR NR NR NR 0 0

Hong et al. (2011) 4 29.5

(25-33) IA2-IB1 4 0 NR NR 34 (27-37) NR NR NR NR 1 0

Lu et al. (2013)

25 29 IA2-IB1 25 0 1.3 (0-2)

1 66 3 2 1 3 NR NR

Current data

79 31 IA2-IIA1 60 19 1.3(0-4.4) 12 44 (3-105)

2 2 6 4 9 (11) 1 (1.3)

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Summary -1• VRT

– More than 1000 cases published – Consistent low recurrence rate (<5%) – Best obstetrical outcome compared with other techniques. – Difficult to learn

• ART – More than 300 cases published – Easier to learn, no skill and instrumentation → most popular – Excessive radicality and patients selection

• RRT – Very attractive approach and good compromise to the ART – Oncological and obstetrical outcomes ??? – Main limitation : access to the robot system

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Summary - 2

• LRT – Technical challenges and extensive surgical skills – Onclogically safe alternative to radical hysterectomy for young women with early-stage cervical cancer.

– Reproductive outcomes were promising after LRT. – However, tumor > 2 cm and stromal invasion > 50% were significantly associated with increased risk of recurrence after LRT. Therefore, adjuvant therapy such as chemotherapy is recommended for these patients.

Conclusions

• Radical trachelectomy procedure has revolutionized the management of early-stage cervical cancer.

– Classic radical hysterectomy is no longer the criterion standard for young women with small lesions.

– Trend toward even more conservative surgery in carefully selected low-risk early-stage disease

• Guidelines and clinical protocols for the management of these patients should be created and followed by the gynecologist involved in the counseling and treatment of these patients.

• Further studies are needed to confirm previous results and to assess longterm fertility and oncological results.

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Thank you for your attention !

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Gynecologic Cancer Center Ajou University Hospital

Contact: drchang@ajou.ac.kr