OBJECTIVEWilms' Tumor Trial (WT-99) of Shanghai Children's Medical Center was designed and conducted by applying therapeutic regimens stratified by stage and histology in accordance with National Wilms' Tumor Study (NWTS) criteria of U.S.A. The main aim of WT-99 was to reduce treatment of low-stage, favorable-histology (FH) tumors without impairing survival and to improve prognosis of stage III and IV (FH) and unfavorable-histology (UFH) tremors with more intensive chemotherapy.

METHODSDiagnosis and treatment was decided by the multi-disciplinary team including oncologists, surgeons, pathologists, radiologists and diagnostic radiologists. Twenty consecutively diagnosed patients were recruited between October 1998 and October 2002. The regimen for patients at favorable-histology (FH) stage I and II and anaplastic stage I was vincristine (Vcr) and dactinomycin (Act-D) only, while for those at focal anaplastic stage II to IV and FH stage III and IV the regimen was Vcr, Act-D and adriamycin (Adr). Patients at diffuse anaplastic stage II to IV and clear cell stage I to IV received four-drug regimen including Vcr, etoposide (VP16), Adr and cytoxan (CTX). For those at rhabdoid stage I to IV the regimen was carboplatin, VP-16 and CTX. Un-resectable patients received 2 courses of Ifosfamide, Vcr and VP-16 as pre-surgery therapy. No radiation therapy was used for patients at stage I and FH stage II.

RESULTSTwenty patients, from 7 months to 12 years old, were enrolled. Pathologic analysis showed fourteen cases were at their FH, three at unfavorable-histology (UFH), two at clear cell and one at rhabdoid stage. Five patients were at stage I, five at stage II, six at stage III, three at stage IV and one at stage V. Eighteen reached complete response (90%), and two failed. One relapsed after 24 months of CCR and reached the second CR after intensive chemotherapy. No therapy-related death happened. Survival rate (SR) was 90% (18/20) and event-free survival (EFS) was 85% (17/20) at 11-45 months, average 27 months.

CONCLUSIONMulti-disciplinary team work model and protocol WT-99 are safe and effective for Wilms' tumor.