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Regional hyperthermia plus chemotherapy increased survival in soft-tissue sarcoma
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ECCO 15 – ESMO 34 Multidisciplinary Congress
Updated data from the EORTC-ESHO intergroup trial demonstrated that patients with high-risk soft-tissue sarcoma who received chemotherapy plus regional hyperthermia were 30% more likely to be alive and disease free almost three years after the start of treatment compared with patients assigned to standard chemotherapy alone.
In 2007, researchers reported preliminary results of this trial at the ASCO Annual Meeting. These findings demonstrated that regional hyperthermia improved the outcome in patients with localized, advanced, high-risk soft-tissue sarcoma who were treated with neoadjuvant chemotherapy. The current results include an analysis of therapy-induced responses and survival prolongation.
“These findings provide a new standard treatment option, and we believe they are likely to change the way many specialists treat these tumors,” Rolf Issels, MD, PhD, professor of medical oncology at Klinikum Grosshadern Medical Center at the University of Munich, Germany, said in a press release.
The phase-3 study included 341 patients with high-risk soft-tissue sarcoma who were randomly assigned to etoposide 250 mg/m2, ifosfamide 6 g/m2, adriamycin 50 mg/m2 (EIA) at four cycles every three weeks alone or EIA plus regional hyperthermia both before and after local therapy. The primary endpoint was local PFS; secondary endpoints included objective response rates, time to progression, DFS and OS. Median follow-up was 34 months.
According to data presented by Issels at a press conference of the ECCO 15 – ESMO 34 Multidisciplinary Congress in Berlin, adding regional hyperthermia to chemotherapy reduced the risk for recurrence or death by 42%. Patients assigned to chemotherapy plus regional hyperthermia survived an estimated 120 months before progression vs. 75 months for patients assigned to chemotherapy alone. In addition, compared with chemotherapy alone, the combination improved median DFS (P=.011) and time to progression (P=.006).
The improvement in OS was not significant in the intent-to-treat population. However, when the researchers analyzed OS in patients who completed all four cycles of chemotherapy or four cycles plus eight hyperthermia treatments, OS increased for those assigned to combined treatment (P=.038), and they were 44% less likely to die during follow-up compared with those assigned to chemotherapy alone.
During the press conference, Issels warned that data for OS should be taken with caution, as it only includes a subpopulation of the total study group.
At two years, 76% of patients assigned to regional hyperthermia were alive without local progression compared with 61% of patients assigned to chemotherapy alone. Tumor shrinkage occurred in 12.7% of patients assigned to chemotherapy vs. 28.8% assigned to combination therapy. In addition, tumor growth occurred in 6.8% of those assigned to combination therapy vs. 20% of those assigned to chemotherapy alone.
“This strategy has been in development for about 20 years, with about 150 leading groups studying it, but the clear results of this trial show that the field has now matured to the point where we must step up efforts to explore its potential to offer an entirely new way of treating locally advanced disease in several major cancers,” Issels said.
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