Supplementary appendix

Supplementary appendix
This appendix formed part of the original submission and has been peer reviewed.
We post it as supplied by the authors.
Supplement to: Tristram A, Hurt CN, Madden T, et al. Activity, safety, and feasibility
of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT³VIN):
a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 2014; published
online October 8. http://dx.doi.org/10.1016/S1470-2045(14)70456-5.
Response Evaluation Criteria in Solid Tumours (RECIST)
The following guidelines have been adapted from the RECIST to suit this non-systemic topical treatment of precancerous lesions. All measurements should be taken and recorded in metric notation. RECIST recommends
that skin lesions be documented by color photography, including a ruler to estimate the size of the lesion.
However this is not essential and should only be done in centres that have access to medical photography. We
recommend using paper measuring tapes. The same method of assessment and the same technique should be
used to characterize each identified and reported lesion at baseline and during follow-up.
1. Baseline documentation of treated lesions
All baseline evaluations should be performed as closely as possible to the beginning of treatment and never
more than 4 weeks before the beginning of the treatment.
All VIN lesions up to a maximum ten lesions in total should be identified as lesions to be treated and recorded
and measured at baseline.
A sum of the longest diameter (SLD) for all lesions will be calculated and reported as the baseline SLD. The
baseline SLD will be used as reference by which to characterize the VIN lesion(s).
Below is an example of how to fill this in on the baseline CRF:
2. Documentation of treated lesions after baseline and calculation of the adapted RECIST criteria
Only the dimensions of lesions recorded at baseline should be measured and recorded on the CRF. Any new
lesions should not be included. So the SLDs for each visit should only include the measurements for lesions first
recorded at baseline i.e. those that have been treated for the whole duration of the treatment period. So the only
way that the number of lesions being measured can change during the trial is if some of these original baseline
lesions split up or coalesce. If there are any new lesions then just record them using the two questions about new
lesions on the CRF. If we continue the example from above, if at week 6 the patient had two new lesions but the
original lesions remained unchanged then the 6 week CRF should be completed as follows:
1

0 2
RECIST Criteria
The RECIST criteria at each of the 6, 12, 18, 24 and post-treatment Assessment Visits should be calculated as
follows:
1.
If all of the treated baseline lesions have disappeared then class as COMPLETE RESPONSE otherwise
continue below.
2.
Calculate the minimum sum of longest diameters (minimum SLD) – this is simply the smallest sum of
longest diameters of all the visits prior to the one for which you are assessing the RECIST criteria. It may or
may not be the same as the baseline visit. For example, if you are filling in a week 12 CRF and baseline SLD
was 65mm and week 6 SLD was 60mm then your minimum SLD would be 60mm.
3.
Divide the current SLD by the minimum SLD. If the result is greater than equal to 1.2 then class as
PROGRESSIVE DISEASE otherwise continue below. This demonstrates an increase of at least 20%.
4.
Divide the current SLD by the baseline SLD. If the result is less than or equal to 0.7 then class as
PARTIAL RESPONSE otherwise class as STABLE DISEASE. This demonstrates a decrease of at least 30%.
Adapted from: http://ctep.cancer.gov/forms/quickrcst.doc
2
Recruitment by centre
Site
Patients recruited
(n)
Principal investigator
Llandough
35
Amanda Tristram
Kent and Canterbury
29
Andrew Nordin
Liverpool Womens Hospital
15
John Kirwan
The Great Western Hospital
10
John Cullimore
James Cook University Hospital
9
Derek Cruikshank
Southmead
9
Dina Bisson
Queen Elizabeth (Gateshead)
8
Raj Naik
Maidstone
7
Stephen Attard-Montalto
University Hospital of North Durham
7
Partha Sengupta
Stoke Mandeville Hospital
5
Geraldine Tasker
Royal Bournemouth
4
Padma Eedarapali
Royal Devon & Exeter Hospital
4
Nigel Acheson
Coventry and Warwickshire
4
Ramanand Athavale
Nottingham City
3
David Nunns
Kings Mill Hospital
3
Clive Gie
Worthing Hospital
3
Michael Rymer
Royal Sussex County Hospital
3
Elizabeth Derrick
Whipps Cross University Hospital
2
Karen Gibbon
Cumberland Royal Infirmary
2
Shelia Pearson
Gloucestershire Royal
2
Kathryn Hillaby
Stafford General Hospital
2
Kirk Chin
Northampton General Hospital
2
Alastair Duncan
Addenbrookes Hospital
2
Peter Baldwin
St Mary's Manchester
2
Henry Kitchner
Peterborough District Hospital
1
Bruce Ramsay
Countess of Chester
1
Jed Hawe
Cheltenham
1
Kathryn Hillaby
New Cross Hospital
1
Alaa Elghobashy
St James' Leeds
1
Richard Hutson
University Hospital of North Staffordshire
1
Charles Redman
Tameside
1
Kyle Gilmour
Salford Royal Hospital
1
Brett Winter-Roach
3

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