Treatment with a full-dose regimen consisting of an anthracycline plus ifosfamide administered for 3 courses prior to surgery improves relapse-free and overall survival, in contrast with other regimens, among patients with localized, high-risk soft tissue sarcoma of the extremities and trunk wall, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1

An Italian Sarcoma Group trial demonstrated an overall survival benefit with 5 cycles of adjuvant full-dose epirubicin plus ifosfamide versus no chemotherapy in localized high-risk soft tissue sarcoma, and a subsequent study showed no difference between 3 and 5 cycles of the same regimen given in the neoadjuvant setting. Researchers compared the efficacy of a neoadjuvant full-dose anthracycline- and ifosfamide-containing regimen with other regimens.

For the multicenter, phase 3 trial ( Identifier: NCT01710176), investigators enrolled 287 adult patients with localized high-risk soft tissue sarcomas. Of those, 97 had undifferentiated pleomorphic sarcoma, 65 had myxoid liposarcoma, 70 had synovial sarcoma, 28 had leiomyosarcoma, and 27 had malignant peripheral nerve sheath tumors.

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Participants were randomly assigned to receive 3 courses of full-dose epirubicin plus ifosfamide or a histology-driven regimen.

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Median follow-up was 12.3 months. Epirubicin plus ifosfamide was associated with an absolute benefit of about 20% overall for both relapse-free survival and overall survival compared with other chemotherapy regimens.

At 46 months, the probability of relapse-free survival in the epirubicin plus ifosfamide arm was 0.62 versus 0.38 in the histology-driven arm (P = .004); the overall survival probability was 0.89 and 0.64, respectively (P = .033).


  1. Gronchi A, Ferrari S, Quagliuolo V, et al. Full-dose neoadjuvant anthracycline + ifosfamide chemotherapy is associated with a relapse free survival (RFS) and overall survival (OS) benefit in localized high-risk adult soft tissue sarcomas (STS) of the extremities and trunk wall: Interim analysis of a prospective trial. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.