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Hyperthermie und Radioonkologie:
Schwerpunkte der klinischen
Evolution
Lunchsymposium Dr. Sennewald Medizintechnik GmbH
DEGRO 2009, Bremen, 12. Juni 2009
Oliver J. Ott
Universitätsklinikum Erlangen, Strahlenklinik
University Cancer Center Erlangen
2
Bladder Cancer
Cervical Cancer
Head & Neck Cancer
Anal Canal Carcinoma
Colombo R et al. J Clin Oncol 2003 Harima Y et al. Int J Hyperthermia 2001
Datta NR et al. Int J Hyperthermia 1990 Kouloulias V et al. Am J Clin Oncol 2005
Hyperthermie Wirksam oder nicht?
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Esophageal Cancer Malignant Melanoma
GBM
Head & Neck Cancer Head & Neck Cancer Cervical Cancer
Sugimachi K et al. Int J Hyperthermia 1992 Overgaard J et al. Lancet 1995 Sneed PK et al. IJROBP 1998
van der Zee C et al. Lancet 2000 Valdagni R et al. IJROBP 1994 Valdagni R et al. IJROBP 1994
Hyperthermie Wirksam oder nicht?
4
Breast Cancer Peritoneal Carcinomatosis
Superficial Tumours
Verwaal VJ et al. J Clin Oncol 2003 Vernon CC et al. IJROBP 1996
Jones E et al. J Clin Oncol 2005
Hyperthermie Wirksam oder nicht?
6
Russian Trial: Flow Chart
T4NXM0 n = 115
R
A
N
D
O
M
10x 4 Gy n = 59
10x 4 Gy
+ Hyp. n = 56
RESECTABLE
Surgery n = 47
10x 4 Gy n = 68
YES
NO
Berdov BA et al. Int J Hyperthermia 1990;6:881-90
Rectal Cancer and Hyperthermia Randomised Trials
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Berdov BA et al. Int J Hyperthermia 1990;6:881-90
Rectal Cancer and Hyperthermia Randomised Trials
Russian Trial: Results
Endpoint RT + HT RT alone P-Value
Complete Response 16 % 2 % < 0.05
Partial Response 54 % 34 % < 0.05
Resection Rate 55 % 26 % n.a.
Overall Survival (5y) 36 % 7 % < 0.05
n.a. = not available
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German Trial: Flow Chart
Rau B et al. Viszeralchirurgie 2002;37:379-84 Schulze T et al.
Int J Hyperthermia 2006;22:301-18
Rectal Cancer and Hyperthermia Randomised Trials
uT3, uT4 n = 137
R
A
N
D
O
M
RCT n = 68
RCT +
RHT n
= 69
S
U
R
G
E
R
Y
C
H
E
M
O
9
German Trial: Results
Rau B et al. Viszeralchirurgie 2002;37:379-84 Schulze T et al.
Int J Hyperthermia 2006;22:301-18
Rectal Cancer and Hyperthermia Randomised Trials
Endpoint RCT + HT RCT alone P-Value
Response (CR + PR) 66 % 49 % < 0.05
Time to Progression 28 mo 20 mo < 0.05
Local Control (3y) 93 % 93 % n.s.
Overall Survival (3y) 89 % 80 % n.s.
n.s. = not significant
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Recurrent Rectal Cancer and Hyperthermia Published Papers
Reference n Treatment Endpoint
Milani V et al. (2008) 24 Re-RT + RHT Feasibility
Hildebrand B et al. (2004) 9 CTX + RHT Feasibility,
Palliation
Juffermans et al. (2003) 53 Re-RT + RHT Feasibility,
Palliation
Schaffer et al. (2003) 13 Re-RT + RHT Feasibility
Rau B et al. (2000) 18 RCT + RHT Feasibility
Anscher et al. (2000) 3 RCT + RHT Feasibility
Experience of mankind 120 Feasibility
Recurrent Rectal Cancer Prognosis influenced by surgery
11 Dresen RC et al. Annals of Surgical Oncology 2008;15:1937–1947
N = 147 Neoadjuvant (C)RT, Surgery, IORT R0-Recection 57% 5y-Disease-free Survival 34.1%
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Recurrent Rectal Cancer Phase II-Study (HyRec Trial)
1 2 3 4 5 6
Week
d2 d9 d23 d30
d 1-14 d 22-35
Radiotherapy PTV: depending on
former Tx Dose: 45 Gy
5-FU CIV (250 mg/m /d)
Oxaliplatin Bolus (50 mg/m /d)
Deep Regional Hyperthermia
R
E
S
E
C
T
I
O
N
d2 d9 d23 d30 d5 d12 d26 d33 d16 d19
Required Cases n =59
Ansprechpartner: Dr. O. Ott, Erlangen
HyRec Trial Current Status
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04/2009: Protocol submitted to the German Cancer Aid Foundation to get Financial Support
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Analkanalkarzinom Phase II-Studie: Ergebnisse
Kouloulias et al. Am J Clin Oncol 2005;28:91–99
5-Jahres-Kolostomiefreiheit:
95% vs. 68%
zu Gunsten der Hyperthermie
Study-Design
Inclusion Criteria
• Squamous cell cancer
• Anal Canal + Margin
• Age > 18 Jahre
• All Stages except T1 N0
CONTROL - ARM:
EXPERIMENTAL - ARM:
Week
1 2 3 4 5 6
Chemotherapy
MMC: 10 mg/m2
5-FU: 1000 mg/m2/d
Radiotherapy
50.4-59 Gy
Radiotherapy
50.4-59Gy
Chemotherapy MMC: 10 mg/m2
5-FU: 1000 mg/m2/d
Hyperthermia
once/week
5 x 1.8-2 Gy/W
Ansprechpartner: Prof. Dr. G. Grabenbauer, Coburg
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Analkanalkarzinom Phase II-Studie: Hyperthermie
Van der Kwast et al. J Clin Oncol 2007;25:4178-4186
Prostatakarzinom Randomisierte, multizentrische Studie geplant
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Flow Chart
R
A
N
D
O
M
PORT
PORT +
RHT
F
O
L
L
O
W
U
P
S
U
R
G
E
R
Y
PC (R0)
PC (R1/2)
Ansprechpartner: Prof. Dr. C. Belka, München; Prof. Dr. H.J. Feldmann, Fulda