1505P - Comparison of two chemotherapy regimens (AI vs. EIA) combined with regional hyperthermia (RHT) in high-risk soft-tissue sarcoma (HR-STS)

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Soft Tissue Sarcomas
Therapy
Biological therapy
Presenter Philipp Aubele
Authors P.O. Aubele1, E. Kampmann2, G. Schuebbe3, S. Abdel-Rahman3, N. Dieterle3, R. Laubender4, R. Issels5, L.H. Lindner3
  • 1University Hospital Munich – Grosshadern, 81377 - Munich/DE
  • 2Lmu München, University Hospital Munich – Grosshadern, 81377 - Munich/DE
  • 3Dept Internal Medicine Iii Hematology/oncology, University Hospital Munich – Grosshadern, 81377 - Munich/DE
  • 4University Of Munich, Institute of Medical Informatics, Biostatistics, and Epidemiology, 81377 - Munich/DE
  • 5Dept. Of Medicine Iii, Helmholtz Zentrum München, Neuherberg/Munich/DE

Abstract

Introduction

A phase III study showed that RHT combined with EIA (E = etoposide, I = ifosfamide and A= doxorubicin) is effective in HR-STS (Lancet Oncol, 2010). EIA + RHT significantly improved tumor response and prolonged local progression-free (LPFS) and disease-free survival (DFS). Due to the mutagenic potential of etoposide the EIA-regimen was modified thereafter. Here we report a retrospective single center sequential analysis of EIA vs. AI both combined with RHT.

Methods

Patients (pts) with localized HR-STS received EIA (E:125mg/m2; I:6g/m2; A:50mg/m2) or AI (A:60mg/m2; I:9g/m2) with RHT (Tmax. 42°C; 60min.). Inclusion criteria and procedures were equivalent to the protocol of the phase III study. Response was evaluated according to RECIST and survival parameters were analysed using cox regression models, Kaplan-Meier and chi-square test. Possible confounders were selected by backward elimination using the likelihood ratio test.

Results

106 Patients (median age 48 years; 19 - 70) were treated with EIA (42pts; from 2006 – 2008) or AI (64pts; 2009 – 2012) with a median follow up of 28 months for EIA and 10 months for AI. Best clinical response rate (CR + PR + SD) for EIA + RHT was 89% compared with 97% for AI + RHT (p = 0,59). Risk for local disease progression or death was not significantly different (Hazard ratio (HR) 0.896; 95% CI 0.433 -1.855; p= 0,767). 1-year rates of LPFS and DFS were 73% [95% CI 0.60 - 0.87] and 73% [95% CI 0.60 - 0.87] for EIA and 77% [95% CI 0.65 - 0.89] and 63% [95% CI 0.49 - 0.77] for AI. Accordingly, for DFS HR was 0.739 (95% CI 0.382 - 1.428; p = 0.368) and for OS HR was 1.011 (95% CI 0.306 - 3.339; p = 0.958). There was also no significant difference in HRs for LPFS, DFS or OS after adjustment for confounders.

Conclusion

Combining both regimens with RHT, AI is an equally effective regimen if compared to the EIA regimen. The efficacy of both regimens combined with RHT is comparable to the published results of the phase III study. P. Aubele, E. Kampmann, G. Schuebbe contributed equally; this work contains parts of the doctoral thesis of G. Schuebbe.

Disclosure

All authors have declared no conflicts of interest.