PMID- 9440748
OWN - NLM
STAT- MEDLINE
DCOM- 19980127
LR  - 20220331
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 16
IP  - 1
DP  - 1998 Jan
TI  - 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.
PG  - 237-45
AB  - 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.
FAU - Green, D M
AU  - Green DM
AD  - Department of Pediatrics, Roswell Park Cancer Institute, University at Buffalo, 
      State University of New York, 14623, USA. green@SC3101.med.buffalo.edu
FAU - Breslow, N E
AU  - Breslow NE
FAU - Beckwith, J B
AU  - Beckwith JB
FAU - Finklestein, J Z
AU  - Finklestein JZ
FAU - Grundy, P E
AU  - Grundy PE
FAU - Thomas, P R
AU  - Thomas PR
FAU - Kim, T
AU  - Kim T
FAU - Shochat, S J
AU  - Shochat SJ
FAU - Haase, G M
AU  - Haase GM
FAU - Ritchey, M L
AU  - Ritchey ML
FAU - Kelalis, P P
AU  - Kelalis PP
FAU - D'Angio, G J
AU  - D'Angio GJ
LA  - eng
GR  - CA-42326/CA/NCI NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 1CC1JFE158 (Dactinomycin)
RN  - 5J49Q6B70F (Vincristine)
RN  - 80168379AG (Doxorubicin)
SB  - IM
MH  - Adolescent
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects
MH  - Child
MH  - Child, Preschool
MH  - Combined Modality Therapy
MH  - Dactinomycin/administration & dosage/adverse effects
MH  - Doxorubicin/administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Humans
MH  - Infant
MH  - Kidney Neoplasms/*drug therapy/pathology/radiotherapy/surgery
MH  - Lung Diseases, Interstitial/etiology
MH  - Neoplasm Staging
MH  - Neoplasms, Germ Cell and Embryonal/*drug therapy/pathology/radiotherapy/surgery
MH  - Nephrectomy
MH  - Vincristine/administration & dosage/adverse effects
MH  - Wilms Tumor/*drug therapy/pathology/radiotherapy/surgery
EDAT- 1998/01/24 00:00
MHDA- 1998/01/24 00:01
CRDT- 1998/01/24 00:00
PHST- 1998/01/24 00:00 [pubmed]
PHST- 1998/01/24 00:01 [medline]
PHST- 1998/01/24 00:00 [entrez]
AID - 10.1200/JCO.1998.16.1.237 [doi]
PST - ppublish
SO  - J Clin Oncol. 1998 Jan;16(1):237-45. doi: 10.1200/JCO.1998.16.1.237.