RITE Thermo-chemotherapy for NON MUSCLE INVASIVE BLADDER CANCER (NMIBC) Ulrich K.Fr. Witzsch

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1 Thermo-chemotherapy for NON MUSCLE INVASIVE BLADDER CANCER (NMIBC) Ulrich K.Fr. Witzsch Klinik für Urologie und Kinderurologie, Chefarzt Prof. Dr. med Dr. hc E. Becht Krankenhaus Nordwest, Stiftung Hospital zum Heiligen Geist Frankfurt/Main Steinbacher Hohl 2-26, Germany

2 Possible conflict of interest Medical enterprise travel expense

3 History

4

5 Hyperthermia Two different approaches to reach the destruction threshold Temp. Temp. HIFU HYPERTHERMIA Time High Temperature (>85 C) Short Time (< 5 Sec.) Time Low Temperature (< 45 C) Long Duration (>1 Hr)

6 Hypothesis of Hyperthermia Acceleration of (bio)chemical processes Hyperthermia external Warm liquid internal Direct cell damage synergistic stimulation of immunological response

7 Hypothesis of Hyperthermia Acceleration of (bio)chemical processes Hyperthermia external Warm liquid internal Direct cell damage synergistic stimulation of immunological response

8 Hypothesis of Hyperthermia Selective death of cancer cells: Cancer cells are more sensitive for heat Vascular damage: Neoangiogenesis is common in malignomas New vessels are fragile Heat leads to vasdilatation and vessel damage

9 Hypothesis of Hyperthermia Synergism of intravesical hyperthermia and chemotherapy Increased binding of Mitomycin to DNA More strandbreaks Increased cell death of duplicating TCC cells Increased permeability into the cell( spontaneous diffusion minimal MW kd) Increased DNA sensitivity to heat

10 The aim more MMC-Molecules permeate into the tumor cell and increase the effect

11 Microwave Radiofrequency treatment alters cancer cell phenotype Matthew J. Ware Published: 13 July 2015 This suggested the malignant cells had undergone a form of radiofrequency shock. Non-malignant cells when subjected to a single RF treatment did not display any significant cytoplasmic retraction or detachment from the substrate surface.

12 Combat BRS HIVEC COMBined Antineoplastic Thermotherapy Bladder Recirculation System Hyperthermic Intra-VEsical Chemotherapy (HIVEC ).

13 Effectivity of chemo thermotherapy Colombo et al. 2003/11 Kiss et al Arends et al Sousa et al Tan et al eau/aua Poster Therapie vs. MMC 40mg vs. BCG HIVEC HIVEC vs. MMC 40mg Patienten 41 vs vs adjuvant / 24 neoadjuvant 153 vs. 154 Risikoklassifikation Intermediate- / high-risk, 1 CIS Intermediate -/ high-risk incl. CIS Intermediate - / highrisk incl. CIS Intermediate - / high-risk incl. CIS Intermediate / high risk : min, 8x 2x20mg/50ml, wöchentl. + 4x 2x30 monatl. MMC: 2x20 mg, 2x30 min, 8x wöchentl. + 4x monatl. * Keine Therapieschema Langzeit-Nebenwirkungen festgestellt. ** Signifikanter Unterschied 2x40mg/50ml, 2x 30min, 12x wöchentl. : 2x30 min, 2x20mg/50ml, wöchentl. + 6x Wochen 6x alle 6 BCG: 6x wöchentl., 3x wöchentl. in Monaten 3, 6, 12 adjuvant: 40mg/50ml, HIVEC/MMC wöchentl. + 6x 60 monatl. min, 4x neoadjuvant: HIVEC/MMC 80mg/50ml, 60 min, 8x wöchentl. vor TUR HIVEC 30 bzw. I: 60 40mg/50ml, wöchentl. + min, 3x 4x monatl. HIVEC II: 40mg/40ml, 60 min, 6x wöchentl. 13

14 ASCO GU 2018 Vögeli et al

15 Synergo Thermose nsoren Spülöffnung Antenne Intravesikale Chemotherapie mit Hyperthermie SWDGU FFM, Witzsch

16 Synergo

17 Synergo Intravesical radiofrequency induced hyperthermia enhances mitomycin C accumulation in tumour tissue Conclusion: Intravesical RF-CHT results in higher tumour MMC concentrations vs. cold MMC instillation which contributes to its superior efficacy.

18 Treatment Induction phase 2 x 40 mg Mitomycin per 30 Min with Hyperthermia 42 C 8 x weekly Control TUR- B 3 weeks after end of Induction phase Maintanance 2 x 20 mg Mitomycin per 30 Min with Hyperthermia 42 C 6 x every 6 Weeks Control cystoscopy every 3 months

19 Population

20 high-risk patients(ptis, pt1 G3, NMIBC and BCG failures n=271) Response rates Induction phase Number Percent No. Patients 271 Complete response Partial response No change

21 Side effects

22 Long term effect

23 Maintanance optimises effect

24 Comparison vs BCG

25 Synopsis RIHTC has low side effects CR after Induction 76,1% (206 of 271) 2y Progression free (CR) group 80,6% (160 of 206) 2y Progression free (all) 59% (160 von 271) Calculated advantage vs BCG 1y 241% 5y 291%

26 Synergo (a) intention-to-treat and (B) per-protocol efficacy analysis sets Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guerin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non Muscle-invasive Bladder Cancer Tom J.H. Arends et al EUROPEAN UROLOGY 69 (2016) , *

27 Synergo (a) intention-to-treat and (B) per-protocol efficacy analysis sets

28 ASCO GU 2018 Long-term results of organ preservation rate and progression risk in high-risk non-muscle-invasive bladder cancer (NMIBC) patients treated with radiofrequency-induced thermochemotherapy effect () with the Synergo system. Jill-Isabel Kilb, Arne Hauptmann, Florian Wagenlehner, Gerson Luedecke Induction 2x40, Maintanance 2x20 67 patients (4 female, 63 male), 65.7% Cis positive rate. 85% of the patients were treated alternatively to BCG with primary 15% were BCG failure patients treated alternatively to indicated cystectomy

29 ASCO GU 2018 Tumor persistence at week 11 after induction therapy proven by TURB was (10/67) 14.9% resulting in early cystectomy (4/10). Mean recurrence free time 3.5 years. In case of recurrence 10.4% progressed to MIBC incl- 6% metastatic tumors, high risk NMIBC was observed in 6% resulting in cystectomy low risk NMIBC recurrence was 1.5% with organ preservation. BC death rate was 1 out of 67. Incomplete treatments induced by SAE of was 9%. Bladder preservation rate was 80.6% with a long-lasting effectiveness ( > 5 years) of 14/26 (53.8%).

30 Synergo AUA2018

31 Synergo AUA 2018 Progression 5% 8% 8% Metastasis 5% Upper UT 6% Cystectomy 23% 10y OAS 54% 10y CSS 75%

32 S3 Leitlinie

33 EAU Guideline Device-assisted intravesical chemotherapy Hyperthermia Promising data have been presented on enhancing the efficacy of MMC using microwave-induced hyperthermia in patients with high-risk tumours [183]. In one RCT comparing one year of BCG with one year MMC and microwaveinduced hyperthermia in patients with intermediate and high-risk bladder cancer, a reduced RFS at 24 months in the MMC group was demonstrated [184] (LE: 1b). Different technologies which increase the temperature of instilled MMC are available, however, data about their efficacy are still lacking. Recommendation: In patients with BCG-refractory tumours, who are not candidates for RC due to comorbidities, use preservation strategies (intravesical chemotherapy, chemotherapy and microwave-induced hyperthermia). Weak

34 NICE guideline 2015 not included 2018 will be included

35 case 45 y, male 01/2012 TUR B: multifokal (4x) pta, high - grade 03/2012 TUR B: benigne 2012 Instillationstherapie mit Mitomycin (8x) 08/2012 TUR B: benigne 02/2013 TUR B: multifokal pta, low - grade 04/2013 TUR B: benigne

36 case 45 y, male 2013 Instillationstherapie mit BCG (bis 12/13) 2014 BCGitis mit hepatischem und pulmonalem Befall, mehrmonatige tuberkulostatische Therapie 08/2015 TUR B: multifokal pta, low grade 09/2015 TUR-B: keine Malignität Auswärtige Empfehlung zur Zystektomie mit Neoblase

37 case 7x TUR-B in 3,5 y 1. recurrance after Instillation with Mitomycin severe BCGitis (hep pul) tuberculostatic therapy for several months 2.recurrance after. BCG

38 case 11/ / Induction Synergo (2x40 mg Mitomycin, weekly) 04 12/ Maintanance Synergo (2x20 mg Mitomycin 6-weekly). 3-monatliche Zystoskopien, since 03/17 Maintanance (2x20 mg Mitomycin, 3-monthly) 2,5 y recurrance free Side effects: urge 1x Botoxinjection 3 /18

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