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.
RCT Entities:
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.
Authors: Marry M van den Heuvel-Eibrink; Janna A Hol; Kathy Pritchard-Jones; Harm van Tinteren; Rhoikos Furtwängler; Arnauld C Verschuur; Gordan M Vujanic; Ivo Leuschner; Jesper Brok; Christian Rübe; Anne M Smets; Geert O Janssens; Jan Godzinski; Gema L Ramírez-Villar; Beatriz de Camargo; Heidi Segers; Paola Collini; Manfred Gessler; Christophe Bergeron; Filippo Spreafico; Norbert Graf Journal: Nat Rev Urol Date: 2017-10-31 Impact factor: 14.432
Authors: Najat C Daw; Yueh-Yun Chi; Yeonil Kim; Elizabeth A Mullen; John A Kalapurakal; Jing Tian; Geetika Khanna; James I Geller; Elizabeth J Perlman; Peter F Ehrlich; Anne B Warwick; Paul E Grundy; Conrad V Fernandez; Jeffrey S Dome Journal: Eur J Cancer Date: 2019-07-17 Impact factor: 9.162
Authors: Conrad V Fernandez; Elizabeth A Mullen; Yueh-Yun Chi; Peter F Ehrlich; Elizabeth J Perlman; John A Kalapurakal; Geetika Khanna; Arnold C Paulino; Thomas E Hamilton; Kenneth W Gow; Zelig Tochner; Fredric A Hoffer; Janice S Withycombe; Robert C Shamberger; Yeonil Kim; James I Geller; James R Anderson; Paul E Grundy; Jeffrey S Dome Journal: J Clin Oncol Date: 2017-12-06 Impact factor: 44.544
Authors: Hemant B Tongaonkar; Sajid S Qureshi; Purna A Kurkure; Mary-Ann A Muckaden; Brijesh Arora; Thyavihalli B Yuvaraja Journal: Indian J Urol Date: 2007-10