Regional hyperthermia (RHT) improves response and survival when combined with systemic chemotherapy in the management of local..

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Regional hyperthermia (RHT) improves response and survival when combined with
systemic chemotherapy in the management of locally advanced, high grade
soft tissue sarcomas (STS) of the extremities, the body wall and the
abdomen: A Phase III randomized prospective study.

 


2007 ASCO Annual Meeting
Abstract No: 10009

Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 10009

 

R. D. Issels, L. H. Lindner, P. Wust, P. Hohenberger, K. Jauch, S.
Daugaard, U. Mansmann, W. Hiddemann, J. Blay, J. Verweij
Abstract:
Background:
Patients (Pts) with locally advanced, high-grade STS are at significant
risk for local failure and for metastasis. We evaluated the ability of
RHT to improve the outcome in pts who are treated with neoadjuvant
chemotherapy.
Methods: Eligibility included pts with STS = 5
cm, grade II/III, deep and extracompartmental, stratified according to
site (E = extremity vs. Non-E = body wall and abdomen). Pts were
randomly assigned to systemic chemotherapy (etoposide 250 mg/m2; ifosfamide 6 g/m2; adriamycin 50 mg/m2)
alone (EIA) or to systemic chemotherapy combined with RHT (EIA + RHT)
administered for 4 cycles every 3 weeks both prior and after local
aggressive therapy (surgery + radiotherapy), respectively. Primary
endpoints were local progression free survival (LPFS) and disease free
survival (DFS). Objective (CR + PR) response rate (ORR) evaluated after
4 cycles (EIA vs EIA + RHT) was a secondary endpoint. A total of 340
pts was required to show an improvement in median LPFS of 19.2 mos for
EIA + RHT (a=5% type I, 20% type II error).
Results: Pts
characteristics were well balanced between treatment arms. After median
follow-up of 24.9 months (mos) an intention-to-treat analysis showed a
significantly superior DFS for pts who received EIA + RHT (n=169)
compared to those treated with EIA alone (n=172) (median DFS: 31,7 mos
and 16,2 mos; log-rank p=0.003; Hazard ratio=0.65; CI95=0.48- 0.87,
p=0.004). The median LPFS was estimated 45,3 mos for EIA + RHT and 23,7
mos for EIA (log-rank p=0.015; Hazard ratio=0.66; CI95=0.48 - 0.90,
p=0.01). At 2 years, LPFS rates for E (149 pts) and for Non-E (192 pts)
were significantly better for EIA + RHT vs EIA alone (E: 84% vs 64%;
Non-E: 57% vs 39%) (p<0.02). The ORR was significantly better for
EIA + RHT (28,7%) vs EIA alone (12,6%) (p=0.002).
 
Conclusions:
Compared to chemotherapy alone, RHT combined with chemotherapy yields a
statistically significant improvement in tumor response , DFS and LPS,
in patients with locally advanced, high-grade STS. (Supported by
Deutsche Krebshilfe and HGF VH-VI- 140)