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Results of the First Prospective Multi-institutional Treatment Study in Children With Bilateral Wilms Tumor (AREN0534). A Report From the Children's Oncology Group.
Peter F Ehrlich1, Murali Chintagumpala2, Yuen Chi3, Fred Hoffer4, Elizabeth Pearlman5, John Kalapurakal6, Anne Warwick7, Robert C Shamberger8, Geetika Khanna9, Arnold Paulino10, Eric Gratias11, Elizabeth Mullen12, James Geller13, Jeff Dome14, Michael Ritchey15
1University of Michigan, Ann Arbor, MI;2MD Anderson Baylor, Houston, TX;3University of Florida, Gainesville, FL;4University of Washington, Seattle, WA;5Luire Childrens Hospital, Chicago, IL;6Northwestern, Chicago, IL;7Walter Reed Medical Center, Washinton, DC;8Boston Childrens and Harvard University, Boston, MA;9University of Washington at St Louis, St Louis, MO;10Md Anderson, Houston, TX;11Childrens Oncology Group, Atlanata, GA;12Dana Farber and Boston Childrens Hopsital, Boston, MA;13University of Cincinnati, Cincinnati, OH;14Children National Medical Center, Washington DC, DC;15Phoenix Childrens Hosptial, Phoenix, AZ

OBJECTIVE(S): No prospective therapeutic clinic trials in children with bilateral Wilms tumors (BWT) exist. Historical outcomes for this group were poor and often involved prolonged chemotherapy; on NWTS-5, 4-year event-free-survival (EFS) and overall-survival (OS) were 61% and 80%. The Children’s Oncology Group (COG) study ARENO534 aimed to improve EFS and OS while preserving renal tissue by intensifying pre-operative chemotherapy completing definitive surgery by 12 weeks from diagnosis and modifying post-operative chemotherapy based on histologic response
METHODS:Patients were enrolled and imaging studies were centrally reviewed to assess for bilateral lesions. Patients with BWT were treated with 3-drug induction chemotherapy (vincristine, dactinomycin and doxorubicin) for 6 or 12 weeks based on radiographic response followed by surgery and further chemotherapy determined by histologic response. Radiation therapy was provided for post-chemotherapy stage III disease
RESULTS: 194/208 patients were evaluable. 4-year EFS and OS were 80.97% (95% CI: 70.98%-90.96%) and 94.16% (95% CI: 88.40%-99.92%). 25 patients relapsed and 7 had disease progression. After induction chemotherapy 163/194 (84.02%) underwent definitive surgical treatment in at least one kidney by 12 weeks and 39% retained parts of both kidneys. Surgical approaches included: unilateral total nephrectomy with contralateral partial nephrectomy (48%), bilateral partial nephrectomy (35%), unilateral total nephrectomy (10.5%), unilateral partial nephrectomy (4%) and bilateral total nephrectomies (2.5%)
CONCLUSIONS: The AREN0534 treatment approach including standardized three-drug preoperative chemotherapy, surgical resection within 12 weeks of diagnosis and response-based post-operative therapy improved EFS and OS and preservation of renal parenchyma compared to historical outcomes for children with BWT.

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