NWTS-4
Fourth National Wilms' Tumor Study (NWTS-4)
N = 1,687
- Population
- Previously untreated children under 16 years of age with Wilms tumour (stages I to IV favourable or anaplastic histology) or clear cell sarcoma of the kidney
- Design
- Cooperative-group study; between August 6, 1986 and September 1, 1994, 1,687 previously untreated children under 16 years of age were randomised to vincristine with either divided-dose (standard, 5 days) or single-dose (pulse-intensive) dactinomycin; high-risk patients also received divided-dose (3 days) or single-dose doxorubicin. Low-risk group: stages I to II favourable histology or stage I anaplastic histology; high-risk group: stages III to IV favourable histology or stages I to IV clear cell sarcoma of the kidney. A second randomisation of 905 children, after the completion of 6 months of chemotherapy, was to stop (short) or continue for 9 additional months (long) of chemotherapy; its low-risk group was stage II favourable histology.
- Arms
- Standard divided-dose schedule (control): Vincristine with divided-dose (standard) courses of dactinomycin (5 days); high-risk patients also divided-dose doxorubicin (3 days)
- Pulse-intensive single-dose schedule (experimental): Vincristine with single-dose (pulse-intensive) dactinomycin; high-risk patients also single-dose doxorubicin
- Long: chemotherapy continued to 15 months (control): Continue chemotherapy for 9 additional months after the first 6 months
- Short: chemotherapy stopped at 6 months (experimental): Discontinue chemotherapy after the first 6 months
- People
- Green DM, National Wilms' Tumor Study Group
Δ 24-month RFS−0.1 pointsΔ 24-month RFS−2.7 pointsΔ 48-month RFS−4.5 pointsΔ 48-month RFS+0.9 points
Show the numbers
| Endpoint | Analysis | Pulse-intensive single-dose schedule / Short: chemotherapy stopped at 6 months | Standard divided-dose schedule / Long: chemotherapy continued to 15 months | Effect |
|---|---|---|---|---|
| RFSLow-risk group (stages I to II favourable histology or stage I anaplastic histology), randomised to dosing schedule | primaryGreen 1998 | 91.3% at 2 y | 91.4% at 2 y | P=.988Randomised numbers as printed: 556 standard, 544 pulse-intensive. The abstract concludes the two have equivalent 2-year RFS. |
| RFSHigh-risk group (stages III to IV favourable histology or stages I to IV clear cell sarcoma of the kidney), randomised to dosing schedule | primaryGreen 1998 | 87.3% at 2 y | 90% at 2 y | P=.865Randomised numbers as printed: 288 standard, 299 pulse-intensive. The abstract concludes the two have equivalent 2-year RFS. |
| RFSLow-risk group (stage II favourable histology) after the second randomisation (stop at 6 months or continue to 15 months) | primaryGreen 1998 | 83.7% at 4 y | 88.2% at 4 y | P=.114-year RFS measured after the second randomisation. Numbers as printed: 190 short, 187 long. |
| RFSHigh-risk favourable-histology patients after the second randomisation (stop at 6 months or continue to 15 months) | primaryGreen 1998 | 89.7% at 4 y | 88.8% at 4 y | P=.874-year RFS measured after the second randomisation. Numbers as printed: 256 short, 246 long. The abstract reports this high-risk comparison for favourable-histology patients. |
| Endpoint | Analysis | Pulse-intensive single-dose schedule / Short: chemotherapy stopped at 6 months | Standard divided-dose schedule / Long: chemotherapy continued to 15 months | Effect |
|---|---|---|---|---|
| RFSLow-risk group (stages I to II favourable histology or stage I anaplastic histology), randomised to dosing schedule | primaryGreen 1998 | 91.3% at 2 y | 91.4% at 2 y | P=.988Randomised numbers as printed: 556 standard, 544 pulse-intensive. The abstract concludes the two have equivalent 2-year RFS. |
| RFSHigh-risk group (stages III to IV favourable histology or stages I to IV clear cell sarcoma of the kidney), randomised to dosing schedule | primaryGreen 1998 | 87.3% at 2 y | 90% at 2 y | P=.865Randomised numbers as printed: 288 standard, 299 pulse-intensive. The abstract concludes the two have equivalent 2-year RFS. |
| RFSLow-risk group (stage II favourable histology) after the second randomisation (stop at 6 months or continue to 15 months) | primaryGreen 1998 | 83.7% at 4 y | 88.2% at 4 y | P=.114-year RFS measured after the second randomisation. Numbers as printed: 190 short, 187 long. |
| RFSHigh-risk favourable-histology patients after the second randomisation (stop at 6 months or continue to 15 months) | primaryGreen 1998 | 89.7% at 4 y | 88.8% at 4 y | P=.874-year RFS measured after the second randomisation. Numbers as printed: 256 short, 246 long. The abstract reports this high-risk comparison for favourable-histology patients. |
Appears in
Sources
Green DM, Breslow NE, Beckwith JB, Finklestein JZ, Grundy PE, Thomas PR, et al. 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. J Clin Oncol. 1998;16(1):237-45.
Green DM, Breslow NE, Beckwith JB, Finklestein JZ, Grundy P, Thomas PR, et al. Effect of duration of treatment on treatment outcome and cost of treatment for Wilms' tumor: a report from the National Wilms' Tumor Study Group. J Clin Oncol. 1998;16(12):3744-51.