Transcript Options for surgical trials in vulva cancer.

Options for surgical trials in vulva
cancer.
Henry Kitchener, University of Manchester
ANZGOG, March 2013
Role of surgery in early vulval cancer
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To effect a cure by preventing recurrence.
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Small tumours (straightforward)
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Large tumours (more complex)
To preserve vulval function and avoid chronic
lymphoedema.
Aims of surgery
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To excise the primary tumour and minimise risk of
local recurrence
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To excise groin nodes (uni or bilateral)
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To stage, in order to plan adjuvant treatment, assess
margins
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To avoid disfigurment
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Conservation of function
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Plastic procedures
Sentinel node surgery in vulval cancer
Photographs courtesy of Dr Cath Holland
Evidence base from Cochrane Reviews of
surgery for VIN and early cancer.
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VIN. (Pepas et al, 2011)
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One RCT of laser vs ultrasonic surgical aspiration.
30 patients; underpowered for primary outcome.
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Early cancer (Ansink et al 1999)
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No adequate RCT’s. 3 observational studies.
Radical local excision is safe (margin >8mm)
Contralateral groin node dissection is unnecessary in lateralised
disease.
Superficial groin node dissection is unsafe.
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Note: Some studies rejected because early cancer could not be
separated, and treatment not uniform.
Track record of surgical research in vulval
cancer.
Generally sparse
 Lack of RCT’s
But
 Surgery has been improved greatly by incremental
change
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Triple incision in the 1980’s
Ipsilateral groin node dissection in the 1990’s
Sentinel node dissection in the 2000’s
Approach has been “Innovate without increasing
hazard”
Vulval cancer surgery
More
radical
Enbloc radical vulvectomy (Way)
1960's
1980's
2000's
Challenges for surgical trials in vulval
cancer.
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Disease is rare
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Survival is generally good
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Many cases are easily managed
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In problem cases, surgery may not be the solution
Vulval cancer: What do we know?
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It exists in two forms
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HPV related (basiloid)
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Lichen sclerosis related (differentiated)
Basiloid
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Preceded by VIN3 whereas (differentiated) arises more
spontaneously
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May be more widespread and difficult to resect conservatively
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Trend has been toward younger women (HPV, smoking)
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HPV vaccination will protect
Vulval cancer: What else do we know?
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Disease presents at an earlier age.
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40-50% are HPV related.
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Groin node dissection and RXT can result in considerable
morbidity.
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Sentinel node detection could avoid the need for most
groin node dissections.
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Chemoradiation can achieve dramatic responses but can
have marked late effects
Role of surgery in VIN 3
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To deal effectively with VIN 3
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Unifocal (easy)
Multifocal (difficult)
To preserve vulval function
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May not be feasible with widespread disease and there is a
risk of recurrence.
But, would anti-HPV strategies be more
effective?
Antiviral Therapy
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Imiquimod
HPV Vaccines
Photodynamic therapy
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50 – 60% response rates
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Need to get rid of HPV 16
Trial in VIN3
Problem:
Widespread VIN3
Hypothesis: Eradication of widespread VIN3 may be
facilitated by antiviral therapy followed
by completion surgery
Intervention: Antiviral therapy followed by surgery
Control:
Antiviral therapy
Outcome:
Time to progression
Power:
Based on superiority (based on 50%
recurrence)
Conclusion
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VIN3/vulval cancer surgical trials are challenging.
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Need GCIG collaboration.
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Role of completion surgery following antiviral therapy
offers a potential trial setting