Treatment of primary, recurrent or inadequately resected high-risk soft-tissue sarcomas (STS) of adults: results of a phase II pilot study (RHT-95) of neoadjuvant chemotherapy combined with regional hyperthermia

The efficacy of thermochemotherapy in adult patients with primary, recurren t or inadequately resected non-metastatic high-risk soft-tissue sarcomas (S TS) was assessed. 54 patients were prospectively treated with four cycles o f etoposide, ifosfamide and doxorubicin (EIA) combined with regional hypert hermia (RHT) followed by surgery, another four cycles of EIA without RHT an d external beam radiation. The objective response rate was 16% and at a med ian follow-up time of 57 months, the 4-year estimated rates of local failur e-free survival (LFFS), distant metastasis-free survival (DMFS), event-free survival (EFS) and overall survival (OS) were 59% (95% confidence interval (CI) 45-73%), 59% (95% CI 44-73%), 26% (95% CI 14-38%) and 40% (95% CI 27- 53%) respectively. OS was in favour of patients responding to neoadjuvant t reatment (P=0.073). In comparison to a preceding phase II study including p re- and postsurgical thermochemotherapy (RHT-91), at a 4-year follow-up the RHT-95 study cohort showed an inferior LFFS rate (P=0.027), but this did n ot affect DMFS (P=0.558) or OS (P=0.126). Hence, postsurgical thermochemoth erapy seems critical for local tumour control without affecting survival. ( C) 2001 Elsevier Service Ltd. All rights reserved.