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The Role of Radiation therapy for Intra- and Extrahepatic Biliary Cancers

The Role of Radiation therapy for Intra- and Extrahepatic Biliary Cancers. C h ristopher H. Crane , M.D. Program Director, GI Section Department of Radiation Oncology . Outline. Liver XRT in the stereotactic era Organ motion management Image guidance (IGRT): CT, CBCT

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The Role of Radiation therapy for Intra- and Extrahepatic Biliary Cancers

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  1. The Role of Radiation therapy for Intra- and Extrahepatic Biliary Cancers Christopher H. Crane, M.D. Program Director, GI Section Department of Radiation Oncology

  2. Outline • Liver XRT in the stereotactic era • Organ motion management • Image guidance (IGRT): CT, CBCT • Neoadjuvant surgery • Functional imaging TC-99 Spect • High dose XRT results • Intrahepatic Cholangiocarcinoma

  3. Outline – con’t • Extrahepatic biliary cancer AHBPA consensus guidelines – (pending) • Adjuvant • Locally advanced unresectable

  4. Intrahepatic Cholangiocarcinoma: High Dose Stereotactic Radiation approaches Intrahepatic Gallbladder Extrahepatic - Hilar Extrahepatic - Periampullary

  5. Challenges of High Dose Liver XRT • Tumor delineation • Sparing (often diseased) liver • Proximity of duodenum, stomach colon • Organ motion • Respiratory motion • Day to day differences

  6. Mechanisms of hepatic failure – liver tumors • HV / IVC occlusion - hepatic congestion – liver ischemia – liver failure • PV occlusion – liver ischemia • Obstruction of the main bile ducts • Biliary sepsis

  7. Budd–Chiarisyndrome = tumor related mortality

  8. RPM System Tracks Breathing Motion during CT marker block with IR-reflecting dots

  9. Targeting the tumor:4D-CT Treatment Simulation

  10. Feedback Guided Gated Breath-hold (FGBH) • Patient to voluntarily holds their breath within the gate (visual feedback helps this process) • Turn the beam on when the patient is holding their breath in the gate. • CBCT or CT-on-rails can be done during FGBHs

  11. Daily CT vs Simulation CT with IVC Daily CT Simulation

  12. CBCT vsSim CT CBCT Sim CT

  13. Unresectable 14 cm IHC -Before XRT

  14. Stereotactic IMRT treatment 100Gy/25x 75Gy/25fx Stomach Max 55Gy

  15. 3 months post therapy

  16. IHCA near stomach: 67.5Gy/15fx - IMRT Stomach/Tumor interface NPO NPO

  17. Neoadjuvant Surgery Laparoscopic/open Alloderm Placement Yoon, et al, PRO, 9/2013

  18. Sometimes the bowel is too closeColon, duodenum, stomach are dose limiting duodenum 0 cm tumor Courtesy Tom Aloia

  19. AlloDerm® Envelope Courtesy Tom Aloia

  20. Open AlloDerm® Spacer Placement Courtesy Tom Aloia

  21. Envelope colon Envelope duodenum 3 cm tumor

  22. Unresectable Intrahepatic Cholangio near Stomach

  23. IMRT after Alloderm Placement 100Gy/25x 75Gy/25fx

  24. IMRT after Alloderm Placement 100Gy/25x 75Gy/25fx

  25. IMRT after Alloderm Placement 100Gy/25x 75Gy/25fx

  26. 6 wk follow-up scan

  27. Pre vs post XRT scan

  28. 99mTc-sulfur colloid SPECT functional treatment planning in patients with hepatoma

  29. IMRT vs Protons • IMRT- better bowel sparing • sharper edge (penumbra) • Protons + Charged particles– better liver sparing • don’t exit, but high dose volume larger

  30. Limitations of IMRT / Liver Primaries “Exit dose”= Must be less than 20-30Gy Inadequate Doses for Tumor Cure (in Larger Tumors)

  31. 25Gy /15fx

  32. MDACC/ MGH Phase II Study Primary Hepatic Tumors2009-0556 • P-01 supported trial in collaboration with MGH • <12 cm hepatic primary tumors • 58 CGE / 15 fractions for central tumors • 67.5 CGE / 15 fractions for tumors >2cm from the hilum • N=54 accrued, 35 IHCCa • 1 in-field progression • No significant toxicity

  33. MGH/MDACCPhase IIPreliminary data • 35 patients w IHCCa accrued from 4/2010 to present • 15 fractions • Peripheral - 67.5 GyE • (Central (within 2 cm portahepatis) – 58 GyE

  34. MGH/MDACC Tolerability • No Gr.3/4 events • No RILD • No Radiation-induced biliary strictures

  35. Results • OS is 58% at 2 years. 1-yr 2-yr • OS 69% 58% • PFS 41% 28% 1 local tumor progression – LC >90%

  36. 80y/0 with HCC – Proton 67.5CGE/15fx 1/3/13 5/14/13 , 11/20/13

  37. MGH/MDACC: Preliminary data High dose Proton Therapy MS- NR >30mo 2 yr OS- 58% MS- 11mo 2 yr OS- 9% MDACC Conventional doses* *Crane IRJOBP, 2002 Unpublished, 6/2013

  38. RTOG 1320 – Phase III Trial Liver Directed Radiation Therapy Followed by maintenance Gem/Cis x 4 Unresectable Cholangioca -liver confined -no cirrhosis or CPC A -up to 2 satellite lesions -12 cm or less Gem/Cis x 4 Re-staging AND Randomization after cycle 3 Radiation Planning during cycle 4 Gem/Cis x 4 • Stratify: • Largest tumor > 6 cm • -satellite y/n Hong, PI, Activation 2014

  39. SummaryAblative Radiation Therapy for IHC • Tumor control is dose related • Proton therapy = higher doses in selected cases • Extremely well tolerated • LC 90-100% • Inoperable patients: Curative treatment option? • 2yOS > 50% • 5yOS- need more FU • Possibly comparable to surgery • Limitations • Proximity to bowel • Metastatic disease control

  40. Biliary Tract Tumors Intrahepatic Gallbladder Extrahepatic - Hilar Extrahepatic - Periampullary

  41. MSKCC Results – Initial site of recurrenceHilarCholangiocarcinoma- 60% of rec LRR 76 pts with HCA 24% R+ resections 25% LN+ 10% Adjuvant therapy CTX- 6 pts CXRT- 2pts Recurrence 41% local 24% regional 36% distant 13% DM + LRR 60% of rec LRR Jarnagin, et al 98, (8) 21 AUG 2003

  42. Unresectable HilarcholangiocarcinomasNon-operative treatment Neoadjuvant CXRT / Transplant Chemoradiation +/- brachytherapy

  43. History of EHBT - Transplantation • Early results (1990’s) of hepatic transplant poor • Considered a contraindication • 5-yr OS *17% , **23% • 47% local / remnant tumor recurrence • Mayo– neoadjuvant CXRT , transplant protocol * Penn, Surgery 1991 **Meyer, Transplantation, 2000

  44. Efficacy of Neoadjuvant Chemoradiation, Followed by Liver Transplantation, for Perihilar Cholangiocarcinoma at 12 US Centers 5 yr OS from presentation 53% 25% dropout 5 yr OS from transplant 65% Gastroenterology Volume 143, Issue 1 2012 88 - 98.e3

  45. Results of palliative EBRT + brachytherapy:Long term OS is possible MS 10-14.6mo Ghafoori, et al, IJROBP 2011

  46. Resected HilarcholangiocarcinomasAdjuvant treatment

  47. Adjuvant Radiation Treatment EHBT – JHU (1996) “Post-operative radiation therapy did not provide a benefit…” • *only 16 patients curatively resected + CXRT • Irradiated pts: more hepatic or HA invasion Nakeeb: Ann Surg, Volume 224(4).October 1996.463-475

  48. Adjuvant Radiation Treatment EHBT JHU MDACC “Post-operative radiation therapy did not provide a benefit…” “CXRT of particular benefit in high-risk patients” *Irradiated pts: more hepatic or HA invasion *Irradiated pts: all R+ or N+ Nakeeb: Ann Surg, Volume 224(4).October 1996.463-475 Borghero Y, Crane et al Ann SurgOnc 2008

  49. MCW results: Improved OS with CXRTResected EHBT (n=90) (2002) • 48% received (C)XRT • MVA: • CXRT improved OS • HR 3.1 p<0.08 • More recent era outcomes improved with multimodality therapy p<0.05 Nakeeb, et al Surgery Volume 132, Issue 4 2002 555 - 564 Improved survival in resected biliary malignancies

  50. Adjuvant CXRT - Improved Survival (2000) R+ tumors R0: MS 18.4 vs 20mo, p=NS • Todoroki et al. IJROBP 46(3);581-587: 2000

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