Abstract

8507 NWTS - 5 was a multi-institutional clinical trial for patients less than 16 years of age at diagnosis with specific renal neoplasms who were diagnosed between August 1, 1995 and May 31, 2002. A uniform approach to the treatment of patients with relapse was employed. 103 patients who relapsed after initial chemotherapy with vincristine, actinomycin D and doxorubicin, and radiation therapy were registered on stratum C of the NWTS-5 Relapse protocol. Twelve patients were not evaluable: 5 due to insufficient data, 6 due to major protocol violations and one for refusal of therapy. Among the 91 remaining patients, 14 with bilateral Wilms tumor at diagnosis, 1 who developed a contralateral relapse, and16 who did not achieve a complete response to the initial therapy were not included in this analysis. Relapse treatment included initial chemotherapy, followed by surgical excision, if feasible, and radiation therapy. Maintenance chemotherapy included alternating courses of the drug pairs of cyclophosphamide and etoposide and carboplatinum and etoposide. The median duration of follow-up of surviving patients was 3.44 years from registration on the relapse protocol. The most frequent toxicity was profound thrombocytopenia that contributed to one on-study death, and discontinuation of maintenance therapy for 12 patients. One patient developed acute myelogenous leukemia. These results demonstrate that approximately one-half of children with Wilms tumor who relapse after initial treatment with vincristine, actinomycin D, doxorubicin and radiation therapy can be successfully re-treated. Author Disclosure Site Number of Patients Number of Second Events 4-year EFS (%) Number of Deaths 4-year Survival (%) All 60 33 42.3 27 48.0 Operative bed lung other 7 6 14.3 4 38.1 Liver other 6 5 16.7 4 33.3 Abdomen or pelvis lung 6 5 16.7 5 0.0 Lung only 33 16 48.9 13 52.8 Lung and other 6 1 80.0 1 80.0 Other 2 0 - 0 - No significant financial relationships to disclose.

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