Prospective randomized evaluation of limb-sparing surgery plus radiation therapy compared with amputation in adults with high-grade soft-tissue sarcomas of the extremities
N = 43
- Population
- 43 adults with high-grade soft-tissue sarcomas of the extremities
- Design
- Prospective randomised trial, May 1975 to April 1981, randomised 2:1. Both groups received postoperative chemotherapy with doxorubicin (maximum cumulative dose 550 mg/m2), cyclophosphamide and high-dose methotrexate. Limb-sparing: wide local excision, then 5000 rads to the whole anatomic area at risk and 6000 to 7000 rads to the tumour bed.
- Arms
- Amputation (control, n = 16): Amputation at or above the joint proximal to the tumour, including all involved muscle groups, plus postoperative doxorubicin, cyclophosphamide and high-dose methotrexate
- Limb-sparing resection plus radiotherapy (experimental, n = 27): Wide local excision plus adjuvant radiotherapy (5000 rads to the area at risk, 6000 to 7000 rads to the tumour bed), plus postoperative doxorubicin, cyclophosphamide and high-dose methotrexate
- People
- Rosenberg SA
Δ 60-month DFS−7 pointsΔ 60-month OS−5 points
Show the numbers
| Endpoint | Analysis | Limb-sparing resection plus radiotherapy | Amputation | Effect |
|---|---|---|---|---|
| DFSRandomised patients (43); the analysis population is not stated in the abstract | primaryRosenberg 1982 | 71% at 5 y | 78% at 5 y | P=p2 = 0.75Five-year disease-free survival as printed in the abstract (71% and 78%); the abstract gives no confidence intervals and does not label the test behind p2. |
| OSRandomised patients (43); the analysis population is not stated in the abstract | primaryRosenberg 1982 | 83% at 5 y | 88% at 5 y | P=p2 = 0.99 |
| Endpoint | Analysis | Limb-sparing resection plus radiotherapy | Amputation | Effect |
|---|---|---|---|---|
| DFSRandomised patients (43); the analysis population is not stated in the abstract | primaryRosenberg 1982 | 71% at 5 y | 78% at 5 y | P=p2 = 0.75Five-year disease-free survival as printed in the abstract (71% and 78%); the abstract gives no confidence intervals and does not label the test behind p2. |
| OSRandomised patients (43); the analysis population is not stated in the abstract | primaryRosenberg 1982 | 83% at 5 y | 88% at 5 y | P=p2 = 0.99 |
Appears in
Sources
Rosenberg SA, Tepper J, Glatstein E, Costa J, Baker A, Brennan M, et al. The treatment of soft-tissue sarcomas of the extremities: prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy. Ann Surg. 1982;196(3):305-15.