Doxorubicin can be safely omitted from the treatment of stage II/III, intermediate risk histology wilms tumour: results of the siop wt 2001 randomised trial [Abstract]

Pritchard-Jones, Kathy, Graf, Norbert, Bergeron, Christophe, de Camargo, Beatriz, van den Heuvel, Marry, Sandstedt, Bengt, Leuschner, Ivo, Vujanic, Gordan, Boccon-Gibod, Liliane, Godzinski, Jan, Oldenburger, Foppe, van Tinteren, Harm and de Kraker, Jan 2011. Doxorubicin can be safely omitted from the treatment of stage II/III, intermediate risk histology wilms tumour: results of the siop wt 2001 randomised trial [Abstract]. Pediatric Blood and Cancer 57 (5) , p. 741. 10.1002/pbc.23299

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Abstract

Purpose: The SIOP WT2001 trial aimed to test whether doxorubicin (D) can be safely omitted from chemotherapy for stage II/III, intermediate risk histologyWilms tumour (WT), in the setting of exclusion of a newly defined high risk subgroup (blastemal-type) from the randomisation. Method: International multicentre trial (28 countries, 261 centres) registering all children diagnosed with a primary renal tumour. Those aged 6 m–18 yrs with localized tumours were treated with 4 weeks pre-operative chemotherapy with vincristine (V) and actinomycin D (A). Tumour stage and histological risk group were assigned after delayed nephrectomy. Stage II/III intermediate risk WTs were randomized between 26 weeks AVor AVD (total Doxo 250 mg/m2). Stage III tumours received 14.4 Gy flank irradiation. Statistics: A noninferiority limit of up to 10% decrease in 2 yr EFS was considered acceptable. Probability of wrongly accepting non-equivalence was set at alpha 0.025, power 0.90 with recruitment target 550 randomised patients. Randomisation was stratified by participating group and tumour stage. Results: 583 patients were randomized between 11/2001–12/2009, with 341 stage II and 242 stage III. Median follow up was 39 months. 94% (512/543) were confirmed as eligible by central pathology review. In intention to treat analysis, there were 22 events (20 relapses)/9 deaths among 291 randomised to AVD and 34 events (27 relapses)/7 deaths among 292 randomised to AV, with 2 yr EFS of 92% (95%CIs: 89–96%) and 89% (95%CIs: 85–93%) (logrank p¼0.06) and 5 yr overall survival of 96% (95%CIs: 94–99) and 96% (95%CIs: 93– 99) (logrank p¼0.61), respectively. The Hazard ratio for any event by 5 yrs in the experimental AV arm compared to standard AVD chemotherapy was 1.67 (95%CIs: 0.98– 2.85, stratified logrank p¼0.058). Analysis confined to eligible patients or by treatment received did not materially affect the results. Conclusion: By using stage and histology after pre-operative chemotherapy for risk stratification, doxorubicin can be omitted from treatment of stage II/III intermediate risk WTs.

Item Type:	Article
Status:	Published
Schools:	Schools > Medicine
Subjects:	R Medicine > R Medicine (General) R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Additional Information:	43rd Congress of the International Society of Paediatric Oncology (SIOP) 2011 Auckland, New Zealand, 28th-30th October, 2011, SIOP Abstracts
Publisher:	Wiley-Blackwell
ISSN:	1545-5009
Last Modified:	06 Jul 2023 01:42
URI:	https://orca.cardiff.ac.uk/id/eprint/21963

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