Variation in adherence to protocol recommendations for pre- and post-operative treatment of children with Wilms tumour in two consecutive studies in the UK and Ireland
Tugnait, S. Al-Saadi, R. Williams, R. Oostveen, M. Dzhuma, K. Brok, J. Irtan, S. Lopez, A. Weeks, M. Bate, J.
Tugnait, S.
Al-Saadi, R.
Williams, R.
Oostveen, M.
Dzhuma, K.
Brok, J.
Irtan, S.
Lopez, A.
Weeks, M.
Bate, J.
Citations
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Abstract
Background and Aims: Wilms tumour (WT) has excellent event-free
and overall survival rates. However, small differences exist between
countries participating in the same international study. This led us
to examine variation in adherence to protocol recommendations as a
potential contributing factor.
Methods: Retrospective analysis of all children with unilateral WT
treated with pre-operative chemotherapy in the SIOPWT2001 (2002-
11) and IMPORT (2012-18) studies in the UK and Ireland. Pre- and
post-operative treatments (including radiotherapy) were classified as:
per protocol (PP); deviation (PDEV) - variation for specified clinical rea-
sons; violation (PVIOL) - not treated per protocol.
Results: 1186 children with WT were registered by 20 centres. 983
(83%) had unilateral WT treated with pre-operative chemotherapy. All
had centrally reviewed pathology. Case Report Forms (CRFs) allow-
ing categorisation of the whole treatment pathway were available for
564 patients. Overall,58% (209/361) were treated PP in SIOPWT2001
and 67% (137/203) in IMPORT. A further 30% (110/361) and 17%
(34/203) respectively classified as PDEV. PVIOL occurred in 12%
(42/361) in SIOPWT2001 and 15% (31/203) in IMPORT. Stage III/IV
tumours had higher proportion PVIOL (18% SIOPWT2001; 28%
IMPORT) compared to stage I/II tumours (8% in both studies). The
highest rates of PVIOL were in stage IV (metastatic) IMPORT patients
(33%). The most common reasons for PVIOL were not changing
to high risk chemotherapy, use of radiotherapy for slow metastatic
responders and prolonged duration of pre-operative chemotherapy.
For children with stage I/II WT, 92%/91% received PP pre-operative
treatment and 79%/82% received PP post-operative treatment in
SIOPWT2001/IMPORT respectively. Correlation of protocol adher-
ence with survival is planned.
Conclusions: Protocol guidelines are followed closely for stage I and II
tumours but there is greater variation in more advanced disease. This
maybe reduced by the more explicit definitions of metastasis and treat-
ment response in the SIOP-RTSG UMBRELLA protocol that succeeded
the IMPORT study in 2019
Description
Date
2020
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Tugnait S, Al-Saadi R, Williams R, Oostveen M, Dzhuma K, Brok J, et al. Variation in adherence to protocol recommendations for pre- and post-operative treatment of children with Wilms tumour in two consecutive studies in the UK and Ireland. Pediatric Blood & Cancer. 2020;67:S67-S