Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 9015
© 2004 American Society of Clinical Oncology

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Abstract

First interim report on the randomized EORTC 62961/ESHO-RHT 95 Intergroup Study (phase III) combined with regional hyperthermia (RHT) versus chemotherapy alone in the treatment of high-risk soft tissue sarcomas (HR-STS) in adults

Klinikum Grosshadern Medical Center, Dept of Internal Medicine III, Munich, Germany; Charite-Campus Buch & Virchow Klinikum, Berlin, Germany; Charite-Campus Virchow Klinikum, Berlin, Germany; Klinikum Grosshadern Medical Center, Institute for Biostatistics & Epidemiology, Munich, Germany; Royal Marsden Hospital, London, United Kingdom; Hospices Civils de Lyon & Ctr L. Bernard, Lyon, France; Erasmus University Medical Center, Rotterdam, Netherlands

9015

Background: Based on our phase II results, RHT is considered a promising neoadjuvant treatment strategy for HR-STS and is being evaluated in a prospective RCT (phase III). We are now reporting the results of the first interim analysis after recruitment of 146 patients (pts) with HR-STS (tumors 5 cm, grade 2 or 3, extracompartmental, and deep). Methods: Between July/97 and Nov/01 all pts have been randomised to receive four pre- and post-operative cycles EIA (etoposide: 250 mg/m²; ifosfamide: 6 g/m²; adriamycin: 50 mg/m²) either combined with RHT (74) or EIA alone (72). Pts were stratified by extremity (E=64) vs non-extremity (Non-E=82), and by primary (S1=65) vs recurrent (S2=29) vs previously inadequate (R1/R2) resected (S3=52) tumors. Results: At Nov/03 224 pts of planned 340 pts (170 pts per arm) have been randomized. For 141 pts entering the protocol treatment, 95% (preoperative) and 89% (postoperative) of prescribed EIA cycles could begiven. 80% (preoperative) an 66% (postoperative) of the planned numbers of RHT applications were performed. Hematological toxicity (grade 3/4) was seen in 17 pts consisting primarily of leucopenia (13) and thrombopenia (4). In 102 pts evaluable (not evaluable S3=33 or other=11) for response after completion of 4 EIA with or without RHT, objective response rate was 28% (2 CR; 27 PR). In addition, 7 pts showed MR (7%), 57 pts SD (56%) and 9 pts PD (6%). Of 135 assessable pts, 33% received no surgery (32 pts S3/R1 and 13 pts other reasons), but 61% received conservative resection (83) and 5% were amputated (7) with 10% histopathological complete necrosis (9). At median follow-up of 36 months (cut-off 4/03) the 3–year local progression free rate (LPFR), distant progression free rate (DPFR), and overall survival (OS) for E are 86.6% (95% CI: 77.3–96.0%), 78.1% (95% CI:67.0–89.1%) and 77.3%(95%CI:65.8–88.7%) andfor Non-E are 40.9%(95% CI:28.1–53.7%), 54.9%(95% CI:40.3–69.5%) and 41.5% (95% CI:28.9–54.0) repectively. Conclusions: The neoadjuvant EIA regimen with or without RHT is feasible and tolerable in the majority of pts. While this is a preliminary report, the estimated 3-year LPFR, DPFR and OS in local-advanced HR-STS pts are encouraging. The second interim analysis is planned for 247 pts.

No significant financial relationships to disclose.

Abstract presentation from the 2004 ASCO Annual Meeting