Why the study?
Does adjuvant chemotherapy with Adriamycin improve disease-free survival in adult patients with high-grade soft-tissue sarcomas of the extremities after local treatment?
RCT (n=59)
Does adjuvant chemotherapy with Adriamycin improve disease-free survival in adult patients with high-grade soft-tissue sarcomas of the extremities after local treatment?
Absolute Event Rate: 79.1% vs 54.3%
p-value: p=<0.005
Adjuvant chemotherapy with Adriamycin significantly improves disease-free survival in adult patients with high-grade soft-tissue sarcomas of the extremities.
Supports adjuvant Adriamycin after local therapy in high-grade extremity STS; confirms DFS benefit in this RCT.
A new trial for evaluating the effectiveness of adjuvant chemotherapy in high-grade soft-tissue sarcomas of the extremities in adult patients is presented. All patients after local treatment were randomized into two arms, one without further therapy and the other to receive adjuvant chemotherapy (Adriamycin [Farmitalia-Carlo Erba, Milan, Italy], 450 mg/m2). The preliminary results of the study are reported at a median observation period of 27.6 months. Of the 59 patients who entered the study, 79.1% in the chemotherapy group are without sign of disease, whereas the corresponding figure in the nonadjuvant chemotherapy group is 54.3%. The difference between the two groups is statistically significant (P less than .005, log rank test). These preliminary observations encourage continuation of the study.
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Gherlinzoni et al. (1986) conducted an RCT in High-grade soft-tissue sarcomas of the extremities (n=59). Adjuvant chemotherapy (Adriamycin) vs. No further therapy was evaluated on Without sign of disease (p=<0.005).
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