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The
treatment of patients with high-grade malignant gliomas with RF-hyperthermia
D.
Hager, H. Dziambor, E. M. App, C. Popa, O. Popa, M. Hertlein
BioMed-Klinik
GmbH, Bad Bergzabern, Germany; KSN-Klinik Friedenweiler GmbH, Bad Bergzabern,
Germany
With
a median survival time (MST) of 10-12 months the prognosis of pts with
high-grade malignant gliomas is still poor.
Radiation may double MST.
Chemotherapy has a marginal effect on MST of 2-4 months in grade III and no
substantial effect in grade IV gliomas.
The primary aim of this feasibility study was to define if brain tumors may be
treated by low-radiofrequency deep hyperthermia (LF-RF-DHT).
The rationals for the use of LF-RF-DHT are:
1. increased SAR in tumor tissue,
2. cytotoxic effects of heat,
3. different electromagnetic interactions with tumor tissue (dielectricity,
conductivity, electric current),
4. anti-vascular effects of heat.
Methods
& Patients. Between 09/97 and 09/02, 36 pts with malignant gliomas (9
pts with anaplastic astrocytome WHO grade III, 27 pts with glioblastoma
multiforme WHO grade IV) were treated with LF-RF-DHT and boswellia serrata, an
inhibitor of leukotriene synthesis.
Pts with inoperable, subtotally resected or recurrent gliomas (WHO grade III and
IV) with progression after radio- and/or chemotherapy and a Karnofsky
Performance Score (KPI) of >50% were included.
Median age of the pts was 37 years (33-50) resp. 48 years (25-72); median KPI
was 70% (50-80) resp. 60% (50-90).
DHT was performed with a 13.56 MHz capacitive coupled RF-device.
The study was designed as a prospective open-label, single-arm, mono-centered
observational phase II trial.
Primary endpoints were MST and quality of life.
The analysis of the survival was calculated on the basis of an
intention-to-treat-analysis.
Results.
DHT of brain tumors with LF-RF-HT (13.56 MHz) is feasible.
The DHT-treatment is well tolerated and even pts at far advanced stages of
disease can be treated.
Partial remission or retardation of tumor growth could be observed.
Prolongation of MST and improvement of quality of live is clinically
significant.
The MST are listed (table):
MST of Pts with Gliomas
(Kaplan-Meier-Estimation) in Months.
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MST from Time of
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Grade III+IV
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Grade III
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Grade IV
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Dx of Disease
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23
(18;29)
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106
(14;197)
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20
(10;31)
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Progression
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19
(13;26)
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47
(8;85)
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15
(10;20)
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LF-RF-DHT
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11
(6;16)
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41
(0;92)
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8
(2;14)
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No of Cases: 35 (f:11,m:25); Censored: 8
(22.2%); Events: 28; Range: 95% Confidence Intervall
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© Copyright 2003
American Society of Clinical Oncology All rights
reserved worldwide
Source: http://www.asco.org/ac/1,1003,_12-002489-00_18-002003-00_19-00102803-00_29-00A,00.asp?cat=CNS+Tumors&parent=
Central+Nervous+System+Tumors&returnpid=2325&SubCat_ID=4
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