Neoadjuvant Chemotherapy With or Without Regional Hyperthermia in Localized High-Risk Soft-Tissue Sarcoma
As reported in JAMA Oncology by Issels et al, long-term follow-up of the phase III EORTC 62961-ESHO 95 trial has shown improved outcomes with the addition of regional hyperthermia to neoadjuvant chemotherapy in patients with high-risk soft-tissue sarcoma.
Study Details
In the open-label trial, 329 adult patients from 9 centers (6 in Germany, 1 in Norway, 1 in Austria, and 1 in the United States) were randomized between July 1997 and November 2006 to receive neoadjuvant chemotherapy consisting of doxorubicin, ifosfamide, and etoposide with (n = 162) or without (n = 167) regional hyperthermia. Patients had a median age of 51 years, and 55% were male.
The primary endpoint was local progression-free survival. Follow-up ended in December 2014.
Survival Outcomes
Median follow-up was 11.3 years. By December 2014, 67% of patients had experienced disease relapse and 57% had died.
Median local progression-free survival was 67.3 months in the hyperthermia group vs 29.2 months in the control group (hazard ratio [HR] = 0.65, P = .002). Median disease-free survival was 33.3 vs 17.4 months (HR = 0.71, P = .01). Median overall survival was 15.4 vs 6.2 years (HR = 0.73, P = .04), with 5-year survival rates of 62.7% vs 51.3% and 10-year survival rates of 52.6% vs 42.7%.
The investigators concluded, “Among patients with localized high-risk soft tissue sarcoma, the addition of regional hyperthermia to neoadjuvant chemotherapy resulted in increased survival as well as local progression-free survival. For patients who are candidates for neoadjuvant treatment, adding regional hyperthermia may be warranted.”
The study was supported by the EORTC Soft Tissue and Bone Sarcoma Group, Deutsche Krebshilfe and Helmholtz Association, and National Institutes of Health.
Rolf Issels, MD, PhD, of the Department of Medicine III, University Hospital, LMU Munich, is the corresponding author for the JAMA Oncology article.
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