TY - JOUR
T1 - Treatment with nephrectomy only for small, stage I/favorable histology Wilms' tumor
T2 - A report from the national Wilms' tumor study group
AU - Green, D. M.
AU - Breslow, N. E.
AU - Beckwith, J. B.
AU - Ritchey, M. L.
AU - Shamberger, R. C.
AU - Haase, G. M.
AU - D'Angio, G. J.
AU - Perlman, E.
AU - Donaldson, M.
AU - Grundy, P. E.
AU - Weetman, R.
AU - Coppes, M. J.
AU - Malogolowkin, Marcio
AU - Shearer, P.
AU - Coccia, P.
AU - Kletzel, M.
AU - Thomas, P. R.M.
AU - Macklis, R.
AU - Tomlinson, G.
AU - Huff, V.
AU - Newbury, R.
AU - Weeks, D.
PY - 2001/9/1
Y1 - 2001/9/1
N2 - Purpose: Children younger than 24 months with small (< 550 g), favorable histology (FH) Wilms tumors (WTs) were shown in a pilot study to have an excellent prognosis when treated with nephrectomy only. Patients and Methods: A study of nephrectomy only for the tratment of selected children with FH WT was undertaken. Stringent stopping rules were designed to insure closure of the study if the true 2-year relapse-free survival rate was 90% or lower. Results: Seventy-five previously untreated children younger than 24 months with stage I/FH WTs for which the surgical specimen weighed less than 550 g were treated with nephrectomy only. Three patients developed metachronous, contralateral WT 1.1, 1.4, and 2.3 years after nephrectomy, and eight patients relapsed 0.3 to 1.05 years after diagnosis (median, 0.4 years; mean, 0.51 years). The sites of relapse were lung (n = 5) and operative bed (n = 3). The 2-year disease-free (relapse and metachronous contralateral WT) survival rate was 86.5%. The 2-year survival rate is 100% with a median follow-up of 2.84 years. The 2-year disease-free survival rate (excluding metachronous contralateral WT) was 89.2%, and the 2-year cumulative risk of metachronous contralateral WT was 3.1%. Conclusion: Children younger than 24 months treated with nephrectomy only for a stage I/FH WT that weighed less than 550 g had a risk of relapse, including the development of metachronous contralateral WT, of 13.5% 2 years after diagnosis. All patients who experienced relapse on this trial are alive at this time. This approach will be re-evaluated in a clinical trial using a less conservative stopping rule.
AB - Purpose: Children younger than 24 months with small (< 550 g), favorable histology (FH) Wilms tumors (WTs) were shown in a pilot study to have an excellent prognosis when treated with nephrectomy only. Patients and Methods: A study of nephrectomy only for the tratment of selected children with FH WT was undertaken. Stringent stopping rules were designed to insure closure of the study if the true 2-year relapse-free survival rate was 90% or lower. Results: Seventy-five previously untreated children younger than 24 months with stage I/FH WTs for which the surgical specimen weighed less than 550 g were treated with nephrectomy only. Three patients developed metachronous, contralateral WT 1.1, 1.4, and 2.3 years after nephrectomy, and eight patients relapsed 0.3 to 1.05 years after diagnosis (median, 0.4 years; mean, 0.51 years). The sites of relapse were lung (n = 5) and operative bed (n = 3). The 2-year disease-free (relapse and metachronous contralateral WT) survival rate was 86.5%. The 2-year survival rate is 100% with a median follow-up of 2.84 years. The 2-year disease-free survival rate (excluding metachronous contralateral WT) was 89.2%, and the 2-year cumulative risk of metachronous contralateral WT was 3.1%. Conclusion: Children younger than 24 months treated with nephrectomy only for a stage I/FH WT that weighed less than 550 g had a risk of relapse, including the development of metachronous contralateral WT, of 13.5% 2 years after diagnosis. All patients who experienced relapse on this trial are alive at this time. This approach will be re-evaluated in a clinical trial using a less conservative stopping rule.
UR - http://www.scopus.com/inward/record.url?scp=0035449082&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035449082&partnerID=8YFLogxK
U2 - 10.1200/JCO.2001.19.17.3719
DO - 10.1200/JCO.2001.19.17.3719
M3 - Article
C2 - 11533093
AN - SCOPUS:0035449082
VL - 19
SP - 3719
EP - 3724
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 17
ER -