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