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Ivan Marri, Camillo Aliberti Unit of Oncological Diagnostic and Interventional Radiology,

Ivan Marri, Camillo Aliberti Unit of Oncological Diagnostic and Interventional Radiology, Delta Hospital AUSL Ferrara, Ferrara Italy camy.ali@libero.it. GEST 2011 April 27-30 Paris DC Bead Terumo Workshop.

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Ivan Marri, Camillo Aliberti Unit of Oncological Diagnostic and Interventional Radiology,

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  1. Ivan Marri, Camillo Aliberti Unit of Oncological Diagnostic and Interventional Radiology, Delta Hospital AUSL Ferrara, Ferrara Italy camy.ali@libero.it GEST 2011 April 27-30 Paris DC BeadTerumo Workshop DEBIRI on colorectal cancer liver metastases: personal experience and tips & tricks

  2. GEST 2011 April 27-30 Paris Intra-arterial treatment of liver malignancy with drug eluting Beads: Global Report of five years of experience (from March 2006 to March 2011) • 357 patientstreated • 626 TACE • 2 casesof major complications • (1 acute pancreatitis and 1 liverabscess)

  3. GEST 2011 April 27-30 Paris DEBDOX DEBIRI ColorectalCancer: 148pts Uveal Melanoma: 78pts Melanoma: 12pts Cholangiocarcinoma: 54pts PancreaticCancer: 8pts BreastCancer: 22pts GastricCancer: 8pts Carcinoid: 20pts Sarcoma: 5pts WillmsCancer: 2pts

  4. GEST 2011 April 27-30 Paris Liver metastases ofColorectalCancer: GeneralReport (From 2006 to 2011) • 148 patientstreated • 254 TACE • 100% technical success • 1 major complication(acute pancreatitis)

  5. GEST 2011 April 27-30 Paris • Pre-TreatmentImaging • Obtaining a triple-phase CT or MRI of the liverismandatorytoevaluate the indicationto the treatment of metastases withDC-Bead • Site and numberof LM • % ofliversubstitution • Vascularmapof the liver • Feedingvesselsof the lesions • Morphologicevaluationofileo-femoralarteries • Additionalimagingexaminationstorule out extrahepaticdiseaseshouldbeperformedas appropriate.

  6. GEST 2011 April 27-30 Paris Loading dose ofIrinotecan Each vial of DC Bead (2ml of Beads) can load 100mg of Irinotecan (loading dose 50mg Irinotecan/ml of Beads) Complete loading achieved within 60-120min: weusuallyloadBeads the daybefore the TACE.

  7. GEST 2011 April 27-30 Paris Choice of Dose For small lesions or lobar treatment: 100mg of Irinotecan loaded in 2ml of Beads + 100mg Irinotecan

  8. GEST 2011 April 27-30 Paris Choice of Dose For larger lesion or full liver treatment: a maximum of 200mg of Irinotecan loaded in 4ml of Beads + 200mg Irinotecan Indication to treatment with DC Bead in patients with liver replacing less than 70% . In case of replacing more than 50% interventional and clinical expertise is required to manage patients.

  9. GEST 2011 April 27-30 Paris Choice of DC Bead size Optimizing drug delivery: preferable use of smallparticles Chemosaturation Size 100-300 μm Size 70-150 μm Deeper penetration into the tumor vascular bed permits to deliver a greater effective dose of drug

  10. GEST 2011 April 27-30 Paris Choice of DC Bead sizeUse of 100-300μm Beads for a standard procedure After TACE Before TACE

  11. GEST 2011 April 27-30 Paris Choice of DC Bead size CE Marked for use ONLY with Irinotecan • Hypovascular metastases • Treatment of microsatellites lesions • Treatment of residual viable tissue after first TACE • Treatment of recurrent lesions

  12. GEST 2011 April 27-30 Paris Hypovascular lesions Before TACE Before TACE After TACE Treatment of microsatellites After TACE

  13. GEST 2011 April 27-30 Paris • Peri-proceduralmedication • Pain treatment: • 1 vial (10mg) of Morphine/100ml of physiological solution e.v. 30min. before the procedure • 1 vial of Morphine/100ml of physiological solution e.v. slow infusion during the TACE • 1 vial of Morphine/100ml of physiological solution very slow infusion afther the procedure • Prophylactic treatment against nausea:1 vial (5mg) of Tropisetron/100ml of phs.sol. e.v. before TACE and at +6 hours • Antibiotic prophylaxis and gastric protection should be administered from day 0 to day 5

  14. GEST 2011 April 27-30 Paris Drugadministration 1Remove the overnatant fluid 2Mix Beads with a solution of 5-10ml ofcontrast media / ml of DC Bead

  15. GEST 2011 April 27-30 Paris • The use of microcatheter is advisable: • Reduces the vasospasm • Permits the catheterization of difficult arteries • Permits an optimal distribution of microspheres Very Slow infusionofBeads!

  16. GEST 2011 April 27-30 Paris Drugadministration A selective (segmental or lobar) approach should be used; only in selected cases full liver treatment.

  17. GEST 2011 April 27-30 Paris Lobarapproach: Place the catheter as selectively as possible in the right or left hepatic artery

  18. GEST 2011 April 27-30 Paris Wholeliver treatment: Place the catheter as selectively as possible in tumors feeding arteries in right and left lobe Do not infuse Beads in common trunk of hepatic artery! High risk of administration of even a few DC Beads into extra-hepatic vessels 6 months after TACE

  19. GEST 2011 April 27-30 Paris DEBIRI administration Pay attention to identify the origin of cystic and pancreatic artery! Pancreatic artery Cystic artery

  20. GEST 2011 April 27-30 Paris EmbolizationEndpoint Injection should be continued until “near stasis” is observed in the artery directly feeding the tumor The aim of TACE with DC Bead is drug delivery not embolotherapy! AFTER TACE BEFORE TACE Endpoint: FULL DOSE (not stasis) No additional embolization should be performed

  21. GEST 2011 April 27-30 Paris Treatment response should be assessed according to modified RECIST (mRECIST)

  22. GEST 2011 April 27-30 Paris DEBIRI in ColorectalL.M.: Report of 120 pts Median survival time 22,4 months. Median time to progression 8.04 months Median duration of response 5,6 months Aliberti et al. JVIR in press

  23. GEST 2011 April 27-30 Paris The associationwithsistemictherapyincrease the responseto treatment • DEBIRI+Sistemictherapy • 63/116 • Mediansurvivaltime 24,6months • Mediandurationofresponse 8,2months • Mediantimetoprogression 10,2months • Only DEBIRI • 53/116 • Mediansurvivaltime 15,7months • Mediandurationofresponse 3,2months • Mediantimetoprogression 4,6months

  24. GEST 2011 April 27-30 Paris DEBIRI ColorectalLiver Metastases treatment algorithm DEBIRI TACE 2/4 ml of Beads Loaded with 100-200mg od Drug 4 week CT/MR or PET Complete Response Partial Response Progression Follow up and other oncological therapy TACE Other oncological therapy Progression TACE

  25. Liver metastases from UvealMelanoma GEST 2011 April 27-30 Paris • 60-70% Intrahepatic diffuse, 30-40% oligonodular • Surgery is feasible in only a minority of patients (30%) . • Systemic chemotherapy (nitrosureas, DITC, Cisplatin and Interferons) has achieved a low median survival (range 5-7 months) • Conventional TACE showed slightly better median survival (10 months) • Other therapeutic approaches (Photodynamic, RT, HIFU) are still investigational and require further supporting data. Palliative therapies have not been shown to significantly improve survival

  26. GEST 2011 April 27-30 Paris Liver metastases from Uveal Melanoma General report (from May 2007 to March 2011): • 78 Patientstreated • 104 TACE

  27. GEST 2011 April 27-30 Paris Liver metastases from Uveal Melanoma Treatment Schedule Beadsize 100-300μm Dose ofdrug 75-150mg (whenispossibleuse the maximum dose) Segmental or lobarapprochifnecessaryispossibletotreatwholeliver. Peri-proceduralmedicationis the sameofcolorectal metastases

  28. GEST 2011 April 27-30 Paris Liver metastases from Uveal Melanoma Results: clinicalresponses One month after TACE we observed a significant reduction (>50%) of the lesional contrast enhancement in 93% of patients We observed an overall Response Rate of 45/52 pts (86%) followed RECIST-modified criteria at 3 months f.u. 37 patients out 52 are alive at time of analysis, with a median time to progression of 7,5 months and median follow-up of 10 months (range 1-24 months) 40% of entire population are alive at 15 months Fiorentini G, Aliberti C, Del Conte A, Tilli M, Rossi S, Ballardini P, Turrisi G, Benea G: Intra-arterial hepatic chemoembolization (TACE) of liver metastases from ocular melanoma with slow-release irinotecan-eluting beads. Early results of a phase II clinical study.In Vivo; 2009 Jan-Feb;23(1):131-7

  29. GEST 2011 April 27-30 Paris Before TACE After TACE Liver metastases fromUveal Melanoma DSA Before TACE After TACE

  30. GEST 2011 April 27-30 Paris Advantagesof TACE with DEBIRI in Liver Metastases • Absenceofsystemictoxicity • Good treatment optionforpatientswithtoxicityofchemotheraphywaitingforfurthertherapy (Chemo-Holiday) • Effectivepalliation in preminenthepaticmetastaticdiseasefromvarioustumors • Probably the best treatment in ocular melanoma patients

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