gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

Local control and progression free survival of 122 pts with high-risk soft tissue sarcomas (HR-STS) after previously inadequate surgery treated with neoadjuvant chemotherapy ± regional hyperthermia (RHT)

Meeting Abstract

  • corresponding author presenting/speaker Rolf Issels - Universitätsklinikum, München, Deutschland
  • Lars H. Lindner - Universitätsklinikum, München
  • Marcus Schlemmer - Universitätsklinikum, München
  • Peter Hohenberger - Universitätsklinikum, Mannheim
  • Peter Wust - Royal Marsden Hospital, London
  • Michael Schmidt - Universitätsklinikum, München
  • Jaap Verweij - Erasmus University Medical Center, Rotterdam
  • Ian Judson - Royal Marsden Hospital, London
  • Karl-Walter Jauch - Universitätsklinikum, München
  • Wolfgang Hiddemann

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocOP603

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk711.shtml

Published: March 20, 2006

© 2006 Issels et al.
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Outline

Text

Introduction: Positive margins after initial surgery of large (≥ 5 cm), high grade and deep HR-STS is a known risk factor for local recurrence and critical for local progression free survival. Beside primary (S1-group) or recurrent (S2-group) HR-STS the EORTC 62961/ESHO RHT 95 intergroup phase III study is recruiting also pts with HR-STS after initial inadequate surgery (S3-group). Therefore we analyzed local control and progression free survival for this subgroup of pts with comparison of outcome to the other both subgroups.

Methods: Among 291 pts (340 pts planned) with HR-STS randomized between 7/97 – 10/05, 122 pts, median age 51 yrs (range 18-69 yrs), primary median tumor diameter 9 cm (range 5-36 cm), all high grade, and extracompartmental entered the protocol after previously inadequate surgery (close margins: < 10 mm or macroscopic residual tumor). The protocol prescribed 4 pre- and 4 postoperative cycles EIA (total dose per cycle: etoposide 250 mg/m2; ifosfamide 6 g/m2; and doxorubicin 50 mg/m2) either combined with RHT (60 min, Tmax (tumor) = 42.5°C) parallel to EIA or EIA alone. In case of measurable tumor, response evaluation and definitive surgery and/or adjuvant radiotherapy were assessed for each patient after the first 4 cycles EIA ± RHT. All pts entering the protocol with primary (S1=137 pts), recurrent (S2=32 pts) or with inadequate resected tumors (S3=122 pts) were stratified to extremity (E=126) or non-extremity (NON-E=165).

Results: For response evaluation of patients with measurable disease after inadequate surgery (41/122) the clinical objective response rate to the neoadjuvant chemotherapy ± RHT (3 CR/10 PR) was 32%. The other pts showed stable disease (2 MR, 21 NC) (56%) or progression of disease (5 PD) (12%). For the 122 pts the 3-year local progression free survival (LPFS) was 60.4% (95% CI 49.9-71%) and - according to site - for E (43 pts) 86.3% (95% CI 74.7-97.8%) and for NON-E (79 pts) 48.3% (95% CI 35-6.1.6%), respectively.

Conclusions: Patients with inadequate surgery (S3) showed a higher objective response rate (32%) if compared with the overall response rate (23%) seen in all 291 pts (S1+S2+S3). Local progression free survival at 3 years for this subgroup was comparable for E (S3=86.3% vs S1 + S2=85.4%)but significantly better for NON-E (S3=48.3% vs S1+S2=33.2%; p<0.05). These pts do obviously benefit from the subsequent treatment regimen despite the high risk for local failure.