Abstract

From Nov. 1990 to Oct. 1994 a total of 97 (72% pretreated) adults with locally-advanced, nonmetastastic soft tissue sarcomas were entered in a protocol (RHT-91) involving regional hyperthermia (RHT) combined with systemic preoperative chemotherapy followed by surgery. Primary tumor grading (84 patients had grade II or III), tumor size (>8 cm) and/or extracompartmental tumor extension (46 patients), or local recurrences (51 patients) were defined as high-risk factors. RHT was produced by an electromagnetic regional heating device (BSD-2000 system). For systemic chemotherapy the 97 patients received etoposide/ifosfamide/doxorubicin (EIA) with RHT being given on day 1 and 4 in repeated cycles (EIA/RHT) every 3 weeks. By the cutoff date for this analysis (Oct. 1994), 70 patients had undergone surgery after receiving EIA chemotherapy combined with RHT; 60 tumors except 10 could be resected without amputation. In 27 patients no further surgical procedure was performed. In 92 evaluable patients, the clinical response rate is 34% (1 CR = complete, 15 PR = partial, 17 MR = minor). 41 patients showed stable disease (NC) and 18 patients showed tumor progression (PD). Pathologic response to preoperative thermochemotherapy was evaluable in 70 patients with 30 responders (=43%) having either >50% histologic necrosis (FHR) within the resected tumors (20 patients) or pathological complete response (pCR) at the time of surgery (10 patients). All patients received-whenever possible-adjuvant chemotherapy and postoperative radiation. At the cutoff date, best response was obtained by the strategy of the RHT-91 study in 40 patients (=41%) showing no evidence of disease (NED) (median observation time = 18 months). An updated report will be given in regard to overall survival for non chemo-pretreated (n = 73) and chemopretreated (n = 24) patients. The protocol of a randomized multicenter trial (RHT-95) in patients with primary or recurrent high-risk soft tissue sarcomas will be presented to further test the potential of preoperative thermochemotherapy compared to neoadjuvant chemotherapy alone in regard to local control and survival. Supported by grant M19/88/Wi9 from the Deutsche Krebshilfe, Bonn.

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