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Treatment With Nephrectomy Only for Small, Stage I/Favorable Histology Wilms’ Tumor: A Report From the National Wilms’ Tumor Study Group

From the Department of Pediatrics, Roswell Park Cancer Institute; School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY; Department of Biostatistics, University of Washington; the Fred Hutchinson Cancer Research Center, Seattle, WA; Department of Pathology, Loma Linda University, Loma Linda; Department of Pediatrics, Los Angeles Children’s Hospital; Department of Pediatrics, School of Medicine, University of Southern California, Los Angeles; Department of Pathology, University of California at San Diego, San Diego, CA; Department of Pediatric Surgery, University of Texas at Houston Health Science Center; Department of Pediatrics, University of Texas M.D. Anderson Cancer Center, Houston; Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX; Department of Surgery, Children’s Hospital; Department of Surgery, Harvard Medical School, Boston, MA; Department of Pediatric Surgery, Denver Children’s Hospital, Denver, CO; Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia, PA; Department of Pathology, The Johns Hopkins Hospital, Baltimore, MD; Department of Pediatrics, Cooper Hospital; Departments of Pediatrics and Oncology, Cross Cancer Institute; the University of Alberta, Edmonton; Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; Department of Pediatrics, James Riley Whitcomb Hospital for Children; Department of Pediatrics, School of Medicine, University of Indiana, Indianapolis, IN; Department of Hematology, St Jude Children’s Research Hospital, Memphis, TN; Department of Pediatrics, School of Medicine, University of Nebraska, Omaha, NE; Department of Pediatrics, Children’s Memorial Hospital, Chicago; Department of Pediatrics, School of Medicine, Northwestern University, Evanston, IL; Department of Radiation Medicine, St Joseph’s Hospital, Tampa, FL; Department of Radiation Oncology, Cleveland Clinic Foundation, Cleveland, OH; and Department of Pathology, Portland, Oregon.

Address reprint requests to Daniel M. Green, MD, Department of Pediatrics, Roswell Park Cancer Institute, Elm and Carlton Sts, Buffalo, NY 14263; email: daniel.green{at}roswellpark.org© 2001 by American Society of Clinical Oncology. 0732-183X/01/1917-3719/$20.00

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.

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