Preliminary results revealed reduction of relapse rate and improved survival. HRQOL is an essential guide in improving the conditions of pediatric cancer survivors.Īs a significant proportion of relapses occurred in the tumor bed or abdomen on patients with the fifth National Wilms Tumor Study stage I anaplastic Wilms tumor (WT), flank radiotherapy was added for stage I anaplastic WT in the subsequent study of the Children's Oncology Group (AREN0321). However, long-term follow-up is required to assess the ultimate renal function outcome. Health-related quality of life (HRQOL) using Pediatric Quality of Life Inventory and Lansky Play Performance Scale revealed significant improvement results of all functioning domains such as physical, social, emotional, and school subscales with P < 0.05 and performance scale (P < 0.04).Ĭonclusions: We suggest SIOP protocol for sBWT and bilateral nephron-sparing surgery in two stages. Mean DTPA glomerular filtration rate was 91.4/ml/min/1.73 m2 preoperatively and that of 3 months after completion of treatment was 84/ml/min/1.73 m2. Recurrence was seen in two patients of whom one had Denys–Drash syndrome. Event-free survival rate was 81.3% and overall survival was 90% over 2–5 years. Tumor with unfavorable histology showed 32% response (ratio of favorable: unfavorable histology 2:1). Mean regression in the size of tumor was 87% in four out of six patients. Among the six patients, there were four girls and two boys with a median age of 2 years. Results: Of nine patients, six were included in the study as three patients lost to follow-up. Statistical Analysis Used: Unpaired t-test and Mann–Whitney U-test were used for analysis. Subjects and Methods: SIOP 93-01 protocol was used to study nine patients of sBWT in a single center and followed up over a period from 2 to 5 years.
Settings and Design: Retrospective and prospective randomized study. 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.Ĭontext: Synchronous Bilateral Wilms tumor (sBWT).Īims: This study aimed to assess the outcome of patients with sBWT treated on SIOP protocol. The null hypothesis, that experimental treatment is less effective than standard treatment, could be rejected (p=0.008). 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%). Both per-protocol and intention-to-treat analyses were done.īy 2 years, 18 recurrences were reported in the standard group, and 22 in the no further chemotherapy group.
Aren0321 qarc trial#
The primary endpoint of this equivalence trial was 2-year event-free survival. Eligible patients were at least 6 months old and had stage I tumours with either intermediate-risk histology or anaplasia. Previous treatment consisted of chemotherapy before nephrectomy of four doses of vincristine and two courses of dactinomycin followed by surgical resection of the tumour.
Aren0321 qarc plus#
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.īetween 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). Now, efforts are aimed at reducing toxicity and burden of treatment by shortening schedules without loss of effectiveness. Present treatment for Wilms' tumour is very successful.
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