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April 1, 1986Journal of Clinical Oncology126 citations

A randomized trial for the treatment of high-grade soft-tissue sarcomas of the extremities: preliminary observations.

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FGF. GherlinzoniGBG. BacciPPPiero Picci

Key Result

Adjuvant chemotherapy with Adriamycin significantly increased the percentage of patients without sign of disease compared to no further therapy (79.1% vs 54.3%, P<0.005).

Study Design

Type

RCT (n=59)

PICO

P
Population
59 adult patients with high-grade soft-tissue sarcomas of the extremities, evaluated after local treatment, followed for a median of 27.6 months.
I
Intervention / Comparator
Adjuvant chemotherapy (Adriamycin) vs No further therapy (450 mg/m2)
O
Primary Outcome
Without sign of disease, p=<0.005

Main Result

Absolute Event Rate: 79.1% vs 54.3%

p-value: p=<0.005

Abstract

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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Cite This Study

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). Adjuvant chemotherapy with Adriamycin significantly increased the percentage of patients without sign of disease compared to no further therapy (79.1% vs 54.3%, P<0.005).

synapsesocial.com/papers/6a93b449cf8b8feb0b4629ebhttps://doi.org/10.1200/jco.1986.4.4.552
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