12 februari 2012: ik ben kanker-actueel aan het herzien en heb de link naar het studieverslag gepubliceerd in The Lancet gecorrigeerd.

4 oktober 2004: Bron: The Lancet d.d. 2 oktober 2004

Vermindering van postoperatieve chemo bij bepaalde vorm van leukemie - bekend onder Wilms' tumor of Wilms' kanker geeft zelfde therapeutische effect als traditionele langdurige chemokuren na operatie, aldus gerandomiseerde fase III studie, met Nederlandse deelname van o.a. Emma kinderziekenhuis. Standaard werd altijd 18 weken chemo gegeven, nu in deze studie nog maar vier weken en effect blijft hetzelfde therapeutische gezien dan. Een mooie conclusie want hiermee worden deze kinderen veel bijwerkingen en belastende chemokuren en ziekenhuisbezoek bespaard en wellicht ook hiermee minder kans op nadelige effecten van de chemokuren op latere leeftijd. De studie is 2 oktober 2004 gepubliceerd in The Lancet. Hieronder het abstract, via The Lancet is volledige artikel en studieverslag te lezen.

Reduction of postoperative chemotherapy in children with stage I intermediate-risk and anaplastic Wilms' tumour (SIOP 93-01 trial): a randomised controlled trial J de Kraker, N Graf, H van Tinteren, F Pein, B Sandstedt, J Godzinski, M F Tournade, for the International Society of Paediatric Oncology Nephroblastoma Trial Committee* Lancet 2004; 364: 1229-35 *Members listed at end of report. Emma Children's Hospital/Academic Medical Centre, Department of Paediatric Oncology, Amsterdam, Netherlands (J de Kraker MD); Universitätsklinik für Kinder und Jugendmedizin, Department of Paediatric Haematology/Oncology, Homburg/Saar, Germany (Prof N Graf MD); Comprehensive Cancer Centre Amsterdam, Netherlands (H van Tinteren MSc); Institut Gustave Roussy, Department of Paediatric Oncology, Paris, France (F Pein MD, M F Tournade MD); Childhood Cancer Research Unit/Astrid Lindgren Children's Hospital, Karolinska Institute, Stockholm, Sweden (B Sandstedt MD); and Marciniak Hospital, Department of Paediatric Surgery, Wroclaw, Poland (J Godzinski MD) Correspondence to: Dr J de Kraker, Department of Paediatric Oncology, Emma Kinderziekenhuis, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, Netherlands j.dekraker@AMC.UVA.nl

Summary Background Present treatment for Wilms' tumour is very successful. Now, efforts are aimed at reducing toxicity and burden of treatment by shortening schedules without loss of effectiveness. The objective of this randomised trial was to assess whether postoperative chemotherapy for patients with stage I intermediate-risk and anaplastic Wilms' tumour could be shortened to only 4 weeks from the standard 18 weeks, while maintaining equivalent event-free survival.

Methods Between June, 1993, and June, 2000, 410 patients were randomly assigned after four doses of vincristine plus one course of dactinomycin postoperatively either to stop further adjuvant chemotherapy (no further chemotherapy group, n=200), or to receive a further two courses of the same chemotherapy (standard group, n=210). Previous treatment consisted of chemotherapy before nephrectomy of four doses of vincristine and two courses of dactinomycin followed by surgical resection of the tumour. Eligible patients were at least 6 months old and had stage I tumours with either intermediate-risk histology or anaplasia. The primary endpoint of this equivalence trial was 2-year event-free survival. Both per-protocol and intention-to-treat analyses were done.

Findings By 2 years, 18 recurrences were reported in the standard group, and 22 in the no further chemotherapy group. Event-free survival was 91·4% (95% CI 87·5-95·2) for the no further chemotherapy group and 88·8% (84·3-93·2) for the standard group (difference=2·6%, upper 97·5% confidence limit 8·4%). The null hypothesis, that experimental treatment is less effective than standard treatment, could be rejected (p=0·008).

Conclusions Shortening duration of chemotherapy could reduce acute and late side-effects and inconvenience for patient and parents while maintaining effectiveness, and could be beneficial in terms of health costs.


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