OncothermiaOncothermiaOncothermiaOncothermia L o c oL o c oL o c oL o c o ---- r e g i o n a l h y p e r t h e r m i a w i t hr e g i o n a l h y p e r t h e r m i a w i t hr e g i o n a l h y p e r t h e r m i a w i t hr e g i o n a l h y p e r t h e r m i a w i t h
Medical Results h i g h t e c h m e d i c i n eh i g h t e c h m e d i c i n eh i g h t e c h m e d i c i n eh i g h t e c h m e d i c i n e
■ First year survival
■ Median survival
■ Efficacy and safety
40
7176
17 16
36
89
68
45
59
8287
72
51
65
97
85 83
68
114
92
25
99
258
103
39
24
0
20
40
60
80
100
120
0
20
40
60
80
100
120
Stomach Colon Rectum Liver Pancreas Lung andbronchus
Breast Kidney andrenal pelvis
Brain GBMStomach Colon Rectum Liver Pancreas Lung andbronchus
Breast Kidney andrenal pelvis
Brain GBM0
50
100
150
200
250
300
0
50
100
150
200
250
300
Oncothermia dataOncothermia data
Oncothermia patient’s numberOncothermia patient’s number
# p
ati
en
ts (
n)
SEERSEER
1st
yea
r s
ur
viv
al
(%)
First year survival comparison Challenge – Oncothermia is taken only in a small fraction of the overall survival. Its effect on the long overall survival could be negligible, even if it is very effective. The aggressive disease with short survival is a chance to indicate the efficacy. In this sense oncothermia is indicated as a feasible, effective method. (A. Szasz, A. Dani, et.al.: Retrospective analysis of 1180 oncological patients treated by electro-hyperthermia, DEGRO 11. Jahreskongress der Deutschen Gesellschaft für Radioonkologie, 26-29 Mai 2005, Kongresszentrum, Karlsruhe)
Studies are single arm, open label, observational for intention-to-treat (ITT) population, dominantly for the patients in late/advanced stages, where the conventional methods have fallen.
A comparison with large databases* was done. The survival rate was the studied endpoint. Inclusion criteria were the inoperable and/or in progression after chemo- and/or radio-therapy. Exclusions were the well known contraindications of oncothermia. The possible negative biases were connected to the missing randomization and the historical arm comparison and the voluntary basis (ITT population). Positive bias is the selected advanced patient-population, the missing “trial attention” and the entirely regular treatment conditions (no extra care is given). The treatment had minor number of erythema (<8%), and rarely subcutaneous fibrosis was observed; no other toxicity was observed except the usual toxic reactions of the complementarily applied
conventional treatments (radio- and/or chemo-therapies). Patients reported (subjective) decrease of adverse effect of parallel conventional therapies, decrease of pain and other subjective symptoms. Most patients reported improvement of their general well-being.
(*) Surveillance, Epidemiology, and End Results (SEER), National Cancer Institute, April 2000, www.seer.cancer.gov; EUROCARE-3, European Cancer Database, www.eurocare.org/profiles/index.html
40
7176
17 16
36
89
68
45
59
8287
72
51
65
97
85 83
68
114
92
25
99
258
103
39
24
0
20
40
60
80
100
120
0
20
40
60
80
100
120
Stomach Colon Rectum Liver Pancreas Lung andbronchus
Breast Kidney andrenal pelvis
Brain GBMStomach Colon Rectum Liver Pancreas Lung andbronchus
Breast Kidney andrenal pelvis
Brain GBM0
50
100
150
200
250
300
0
50
100
150
200
250
300
Oncothermia dataOncothermia data
Oncothermia patient’s numberOncothermia patient’s number
# p
ati
en
ts (
n)
SEERSEER
1st
yea
r su
rviv
al
(%)
Median survival comparison Median survival comparison Median survival comparison Median survival comparison
Oncothermia is applied for liver metastases from colorectal cancer primarily together with chemotherapy (n=30) and as monotherapy, after the failure of the conventional therapies (n=50).
The median survival rate was increased remarkably compared to the historical control.
(Hager ED, Dziambor H,
Hohmann D, Gallenbeck D,
Stephan M, Popa C.et al.: Deep hyperthermia with radiofrequencies in patients with liver metastases from colorectal
cancer. Anticancer Res. 19(4C):3403-3408, 1999)
Definite and impressive results were achieved for brain glioma patients. The median survival was increased by more than 75%, while in the case of the most advanced cohort (Glioblastoma multiforme, WHO IV) the results shows also excellent (more than 50%) gain.
(Szasz A, Sahinbas H: Presentation on the Annual Congress of Hungarian Oncologists, Budapest, 2004)
The retrospective data could be convincingly controlled by comparison of independent clinics, having the same device and treatment protocols for brain gliomas.
(HTT Clinic – Varkonyi A: Brain tumor
treatment by electro-hyperthermia, Annual User’s conference of OncoTherm, St. Istvan University, Godollo, 2003, BioMed Clinic – D.
Hager, H. Dziambor, E. M. App et all. The treatment of patients with high-grade malignant
gliomas with RF-hyperthermia. 39th ASCO Annual Meeting. 2003 (Abstract No. 470); Groenemeyer Clinic – Sahinbas H, Groenemeyer D, Boecher E, Szasz A: Retrospective clinical study of adjuvant electro-
hyperthermia treatment for advanced brain-gliomas, Deutsche Zeitschrift fuer Onkologie, 39:154-160, 2007)
Oncothermia study
Brain gliomas,
Dr. Sahinbas et. al.
Oncothermia study
Brain gliomas,
Dr. Sahinbas et. al.
Average median survival from data-banks
11.35 month
Average median survival from data-banks
11.35 month
74.5%
Patient n
um
ber
12.1
14.6
9.5
12.1
14.6
9.5
19.8
296 287 339 335
140
296 287 339 335
140
296 287 339 335
140
296 287 339 335
140200
400
600
800
1000
1200
1400
1600
200
400
600
800
1000
1200
1400
1600
12.1
14.6
9.5 1011.3
12.1
14.6
9.5
12.1
14.6
9.5
12.1
14.6
9.5
296 287 339 335
140
296 287 339 335
140
1578
296 287 339 335
140
296 287 339 335
140
0
5
10
15
20
25
Me
dia
n s
urv
iva
l(m
)
0
5
10
15
20
25
Me
dia
n s
urv
iva
l(m
)
0
5
10
15
20
25
Me
dia
n s
urv
iva
l(m
)
SEER (Surveillance, Epidemiology, and End Results) by the National Cancer Institute USA, April 2000MRC (Medical Research Council, Brain Tumor Working Party)RTOG(Radiation therapy Oncology Group, EORTC(European Organization for Research and Treatment of Cancer)
RT = Radiotherapy,
PCV= Procarbazine+CCNU(Lomustine)+Vincristine, TMZ= Temizolomide
SEER (Surveillance, Epidemiology, and End Results) by the National Cancer Institute USA, April 2000MRC (Medical Research Council, Brain Tumor Working Party)RTOG(Radiation therapy Oncology Group, EORTC(European Organization for Research and Treatment of Cancer)
RT = Radiotherapy, RT = Radiotherapy,
PCV= Procarbazine+CCNU(Lomustine)+Vincristine, PCV= Procarbazine+CCNU(Lomustine)+Vincristine, TMZ= TemizolomideTMZ= Temizolomide
0
5
10
15
20
25
Me
dia
n s
urv
iva
l(m
)
EORTC RT EORTC RT+TMZ MRC RT total MRC RT+PCV
total
RTOG total
Clinical study
0EORTC RT EORTC RT+TMZ MRC RT total MRC RT+PCV
total
RTOG total
Clinical study
0
200
400
600
800
1000
1200
1400
1600
200
400
600
800
1000
1200
1400
1600Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)Brain-gliomas (all grades)
Brain glioma median survival [month]
11.49 11.3
23.63 23
19.8
n=140n=28970 n=35n=29n=1578
5
15
25
SEER RTOG HTT Clinic BioMed Clinic Groenemeyer
Clinic
Brain glioma median survival [month]
11.49 11.3
23.63 23
19.8
n=140n=28970 n=35n=29n=1578
5
15
25
SEER RTOG HTT Clinic BioMed Clinic Groenemeyer
Clinic
Efficacy and safetyEfficacy and safetyEfficacy and safetyEfficacy and safety
The 3E+3S philosophy of oncotherm together with the scientific and technical solutions is also present in the medical studies. The 3E efficacy is well shown on the Kaplan-Meyer plots for advanced pancreatic and advanced non-small-cell lung cancer results. (The control arms are the historical data form the same physician.) (Dani A, Varkonyi A, Nyiro I, Osvath M.: Clinical experience of electro-hyperthermia for advanced pancreatic tumors, ESHO Conference, Munich, June 2003) and (Dani A.: Electro-hyperthermia for advanced NSCLC tumors, Deutscher Kongress für
Radioonkologie, Strahlenbiologie und Medizinische Physik , Erfurt 10-13 June 2004)
p=0.023
0
0.2
0.4
0.6
0.8
1
0 20 40 60 80 100 120 140
Overall Survival (months)
Pro
ba
bilit
y
Censored
Historical control
Oncothermia
Control arm (n=43)
Median (m) = 11.0
Control arm (n=43)
Median (m) = 11.0
Active arm (n=132)Median (m) = 14.7Active arm (n=132)Median (m) = 14.7
Advanced non-small-cell lung cancer (III+IV)
The 3S safety is well demonstrated on the combination of oncothermia with platinum derivatives and applying it second line with great success, without remarkable toxicity. (Fiorentini G, deGiorgi U, Turrisi G, Rossi S, Dentice P, Bernardeschi P: Deep electro-hyperthermia with radiofrequencies combined with thermoactive drugs in patients with liver metastases from colorectal cancer (CRC): a Phase II clinical study, ICACT 17th, Jan30-Feb2, Paris, France) and (Panagiotou P, Sosada M, Schering S, Kirchner H,: Siloah Clinic, Hannover, Irinotecan plus capecitabine with
regional electrohyperthermia of the liver as second line therapy in patients with metastatic Colorectal Cancer; European Society for Hyperthermic Oncology, June 8-11, 2005 Graz, Austria )
Comaprison of platinum derivatives completed with oncothermia
6 611
44
60
22
11
0
42
58
67
100
8
17
0 00.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
Res
ponse
CEA re
duct
ions
Red
uctio
n ana
lgesi
cs
Bette
r qua
lity o
f life
Burns G
2
Leuko
peni
a G2
Nau
sea &
V. G
3
Nef
roto
xicity G
2
Neu
roto
xicity
G3
clinical response oncothermia related toxicity chemotherapy related toxicity
pe
rce
nta
ge
[%
]
Carboplatine (n=18) [%]
Oxaliplatine (n=12) [%]
Liver metastasis of colerectal CA
response rate [%]
50.7
80
0
30
60
90
First line
(Oxalyplatine+
+folicacid+5-FU)
Second line
(Irinotecan+
+capecitabine+oncothermia)
Our principle, the 3E+3S, makes values for the patients and for their doctors, keep the oncothermia method an excellent weapon against cancer.
__________________________________________________________________________________________________________
Oncotherm Kft. Ibolya u. 2. H-2071 Páty Tel: +36 (0) 23/555-510 Fax: +36 (0) 23/ 555-515 [email protected] www.oncotherm.org
Hot Oncotherm GmbH Bonnerstr. 40. D-53842Troisdorf Tel: +49 (0) 2241/31992-0 Fax: +49 (0) 2241/31992-11 [email protected] www.oncotherm.de
Pancreas CA average survivals
7.1
8.33
11.9
0
2
4
6
8
10
12
14
classical chemotherapy* Gemzar+5FU+LV** classical plus oncothermia
Ave
rag
e s
urv
iva
l [m
on
ths]
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