Effect of duration of treatment on treatment outcome and cost of treatmentfor Wilms' tumor: A report from the National Wilms' Tumor Study group

Purpose: National Wilms' Tumor Study (NWTS)-4 was designed to evaluate the efficacy, toxicity, and cost of the administration of different regimens fo r the treatment of Wilms' tumor (WT). Patients and Methods: Between August 6, 1986 and September 1, 1994, 905 pre viously untreated children aged younger than 16 years with stage II favorab le histology (FH) WT (low-risk [LR]), stages III to IV FH WT, or stages I t o IV clear-cell sarcoma of the kidney (highrisk[HR]) were randomized after the completion of 6 months of chemotherapy to discontinue (short) or contin ue for 9 additional months (long) treatment with chemotherapy regimens that included vincristine and either divided-dose (standard [STD]) courses (5 d ays) or single-dose (pulse-intensive [PI]) treatment with dactinomycin. HR patients also received either divided-dose (STD) courses (3 days) or single -dose (PI) treatment with doxorubicin. Results: The 4-year relapse-free survival (RFS) rates after the second rand omization for LR patients were 83.7% for the 190 patients treated with shor t and 88.2% for the 187 patients treated with long chemotherapy (P = .11). The 4-year RFS rates after the second randomization for HR FH patients were 89.7% for the 256 patients treated with short and 88.8% for the 246 patien ts treated with long chemotherapy (P = .87). The charge for treatment with the short PI treatment regimens for all children with stages I through IV F H WT was approximately one half of that with the long STD treatment regimen s. Conclusion: The short administration schedule for the treatment of children with WT is no less effective than the long administration schedule and can be administered at a substantially lower total treatment cost. (C) 1998 by American Society of Clinical Oncology.