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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

    Universittsklinikum 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?

  • 3

    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?

  • 5

    Rectal Cancer

  • 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

  • 7

    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

  • 8

    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

  • 10

    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;15:19371947

    N = 147 Neoadjuvant (C)RT, Surgery, IORT R0-Recection 57% 5y-Disease-free Survival 34.1%

  • 12

    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

    13

    04/2009: Protocol submitted to the German Cancer Aid Foundation to get Financial Support

  • 14

    Anal Carcinoma

  • 15

    Analkanalkarzinom Phase II-Studie: Design

    Kouloulias et al. Am J Clin Oncol 2005;28:9199

  • 16

    Analkanalkarzinom Phase II-Studie: Hyperthermie

    Kouloulias et al. Am J Clin Oncol 2005;28:9199

  • 17

    Analkanalkarzinom Phase II-Studie: Ergebnisse

    Kouloulias et al. Am J Clin Oncol 2005;28:9199

    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

  • 19

    Prostate Cancer

  • 20

    Analkanalkarzinom Phase II-Studie: Hyperthermie

    Van der Kwast et al. J Clin Oncol 2007;25:4178-4186

  • Prostatakarzinom Randomisierte, multizentrische Studie geplant

    21

    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, Mnchen; Prof. Dr. H.J. Feldmann, Fulda