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November 1986

Doxorubicin Chemotherapy in the Treatment of Soft-Tissue Sarcoma: Combined Results of Two Randomized Trials

Author Affiliations

From the Departments of Surgery (Dr Wilson) and Pathology (Dr Corson), Brigham and Women's Hospital, Boston; Medical Oncology (Dr Antman) and Biostatistics (Dr Amato), Dana-Farber Cancer Institute, Boston; Medical Oncology (Drs Harmon and Carey), Pathology (Dr Proppe), Radiation Oncology (Dr Suit), and Surgery (Dr Wood), Massachusetts General Hospital, Boston; Radiation Oncology, University of Massachusetts Medical Center, Worcester (Dr Greenberger); and Surgery, Pennsylvania Hospital, Philadelphia (Dr Lerner).

Arch Surg. 1986;121(11):1354-1359. doi:10.1001/archsurg.1986.01400110146025

• In 1978, there were initiated two independent randomized, prospective trials of adjuvant doxorubicin hydrochloride (Adriamycin) following primary therapy for soft-tissue sarcoma. The virtual identity of these two protocols permits their combination for analysis. A total of 75 patients (42 men, 33 women) with soft-tissue sarcoma (stages IIB to IVA) were randomized, after receiving optimal regional therapy, to receive either doxorubicin hydrochloride (450 mg/m2) (37 patients) or observation (38 patients). Follow-up has ranged from 16 to 80 months (median, 49 months). Twenty-five patients (33%) died, and two patients receiving doxorubicin developed cardiotoxicity. No significant differences in local control, metastasis-free survival, disease-free survival, and overall survival were observed for the two treatment arms. Despite temporary prolongation of disease-free survival with doxorubicin in some subgroups, we conclude that there is no advantage to the use of adjuvant doxorubicin in the treatment of soft-tissue sarcoma.

(Arch Surg 1986;121:1354-1359)

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