Regional hyperthermia (RHT) plus neoadjuvant chemotherapy improves survival among patients with localized high-risk soft tissue sarcoma, according to a study published in JAMA Oncology.1
Previous studies demonstrated that hyperthermia with chemotherapy and ionizing radiation may have a synergistic relationship.
For the open-label phase 3 EORTC 62961-ESHO 95 study (ClinicalTrials.gov Identifier: NCT00003052), researchers randomly assigned 341 patients with soft tissue sarcoma to 4 cycles of neoadjuvant chemotherapy (doxorubicin, ifosfamide, and etoposide) alone or with RHT every 3 weeks. Stratification was done by tumor presentation and site.
After a median follow-up of 11.3 years, 67% (220) of patients had disease relapse (95% CI, 62%-72%), and 57% (188) had died (95% CI, 52%-62%).
Patients who received RHT with chemotherapy had improved local progression-free survival (PFS) (hazard ratio [HR], 0.65; 95% CI, 0.49-0.86; P = .002) compared with chemotherapy alone.
Patients in the RHT arm also had prolonged overall survival compared with patients in the neoadjuvant therapy alone arm (HR, 0.73; 95% CI, 0.54-0.6998; P = .04).
Patients receiving RHT had a 5-year survival rate of 62.7% (95% CI, 55.2%-70.1%) compared with 51.3% (95% CI, 43.7%-59.0%) among patients who received chemotherapy alone. The 10-year survival rate for patients in the RHT arm was 52.6% (95% CI, 44.7%-60.6%) vs 42.7% (95% CI, 35.0%-50.4%) among patients who received chemotherapy alone.
The study was halted after the experimental arm showed significantly improved relapse-free and overall survival rates compared with the control.
The authors concluded that “for patients who are candidates for neoadjuvant treatment, adding RHT may be warranted.”
- Issels RD, Lindner LH, Verweij J, et al. Effect of neoadjuvant chemotherapy plus regional hyperthermia on long-term outcomes among patients with localized high-risk soft tissue sarcoma. JAMA Oncol. 2018 Feb 15. doi: 10.1001/jamaoncol.2017.4996 [Epub ahead of print]