Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: a report from the National Wilms' Tumor Study Group.

Abstract

PURPOSE:

The National Wilms' Tumor Study (NWTS)-4 was designed to evaluate the efficacy, toxicity, and cost of administration of different regimens for the treatment of Wilms' tumor (WT).

PATIENTS AND METHODS:

Between August 6, 1986 and September 1, 1994, 1,687 previously untreated children less than 16 years of age with stages I to II/favorable histology (FH) or stage I/anaplastic histology WT (low-risk [LR] group) or stages III to IV/FH WT or stages I to IV/clear cell sarcoma of the kidney (high-risk [HR] group) were randomized to treatment that included vincristine and either divided-dose (standard [STD]) courses (5 days) or single-dose (pulse-intensive [PI]) treatment with dactinomycin. HR patients also received either STD courses (3 days) or PI treatment with doxorubicin.

RESULTS:

The 2-year relapse-free survival (RFS) rates for LR patients were 91.3% for 544 randomized to treatment with PI and 91.4% for 556 randomized to treatment with STD chemotherapy (P = .988). The 2-year RFS rates for HR patients were 87.3% for 299 randomized to treatment with PI and 90.0% for 288 randomized to treatment with STD chemotherapy (P = .865).

CONCLUSION:

We conclude that patients treated with PI combination chemotherapy for LR or HR WT or clear cell sarcoma of the kidney have equivalent 2-year RFS to those treated with STD regimens. PI drug administration is recommended as the new standard based on demonstrated efficacy, greater administered dose-intensity, less severe hematologic toxicity, and the requirement for fewer physician and hospital encounters.

• Authors: D M Green, N E Breslow, J B Beckwith, J Z Finklestein, P E Grundy, P R Thomas, T Kim, S J Shochat, G M Haase, M L Ritchey, P P Kelalis, G J D'Angio
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 16 Issue 1 Pg. 237-45 (Jan 1998) ISSN: 0732-183X [Print] United States
• PMID: 9440748 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Dactinomycin
• Vincristine
• Doxorubicin

Topics

• Adolescent
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Combined Modality Therapy
• Dactinomycin (administration & dosage, adverse effects)
• Doxorubicin (administration & dosage, adverse effects)
• Drug Administration Schedule
• Humans
• Infant
• Kidney Neoplasms (drug therapy, pathology, radiotherapy, surgery)
• Lung Diseases, Interstitial (etiology)
• Neoplasm Staging
• Neoplasms, Germ Cell and Embryonal (drug therapy, pathology, radiotherapy, surgery)
• Nephrectomy
• Vincristine (administration & dosage, adverse effects)
• Wilms Tumor (drug therapy, pathology, radiotherapy, surgery)