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Using Spacers for Delivery of High Dose Radiation
Theodore Hong, MDDirector, Gastrointestinal Radiation Oncology
Massachusetts General Hospital
Associate Professor of Radiation Oncology
Harvard Medical School
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Disclosures
• No relevant financial disclosures to material in this presentation
• Research Funding- Novartis• Advisory Board- Eisai
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The problem of bowel toxicity
• High dose, advanced radiation is effective in the treatment of intrahepatic cholangiocarcinoma
• Protons/IMRT can not solve the problem of tumor in contact with a mucosal surface
• Solution- Manual Displacement
Yoon SS, et al. Pract Radiat Oncol 2014
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MGH/MDACC/UPENN phase II
• 43 patients– 41 ICC, 2 mixed HCC/ICC
• 4 did not receive treatment– 3 could not meet dosing constraints– 1 became ineligible due to ECOG– Median longest tumor diameter (N=3):
• 6.9 cm (range 4.4 - 9.0 cm)
Hong TS, et al. ASCO 2015
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Treatment• 15 Fractions• Peripheral - 67.5 Gy• Central (within 2 cm porta hepatis) – 58 Gy
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Results• 39 analyzed
– 37 ICC, 2 mixed HCC/ICC– Median age – 66 years (range 29-87 years)– Cirrhosis
• None- 1 (3%)• Childs A – 34 (87%)• Childs B – 4 (10%)
– Prior systemic therapy – 24 pts (62%)– Number of tumors
• 1 lesion – 33 (85%)• 2 lesions – 4 (10%)• 3 lesions – 2 (5%)
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Results
Variable Minimum Median Maximum
Longest tumor dimension (cm) 2.2 5.8 10.9
CA 19-9 at baseline (u/mL) 0 72 10,549
Dose prescribed (Gy) 45 58 67.5
Dose received (Gy) 15.1 58 67.5
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Gr 3 Radiation-Related Toxicity3 pts (8%)
• Hyperbilirubinemia – 1 pt• Stomach ulcer – 1 pt• Liver failure – 1 pt• Ascites – 1 pt
1 patient had both liver failure and ascites.
No grade 4 radiation-related toxicities.
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Outcomes
Endpoint 1-year 2-year
Local Control 97% 90%
Overall Survival 69% 44%
Progression-Free Survival
40% 28%
Median follow up duration among 19 survivors:
13.2 months (range 0.6 – 50.4 months)
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OS – All Treated Subjectsn=39
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PFS – All Treated Subjectsn=39
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Outcomes- Exclude Child’s Bn=35
Endpoint 1-year 2-year
Local Control 96% 90%
Overall Survival 75% 48%
Progression-Free Survival
45% 32%
Median follow up duration among 18 survivors:
14.9 months (range 0.6 – 50.4 months)
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OS – Exclude Child’s Bn=35
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PFS – Exclude Child’s Bn=35
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Conclusions
• High dose, hypofractionated radiation (with protons) is associated with high rates of local control in ICC
• Radiation is safe• Long term survival is possible• These data form the foundation for NRG
GI-001
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Use of biologic spacers
• Ablative radiation dose can be limited by the immediate proximity of radiation-sensitive organs, including bowel
• Larger issue if hypofractionated doses are used.
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MGH/MDACC experience
• 14 patients• Retrospective review• Patients selected if tumor was in contact
or within 1 cm of mucosal surface
Yoon SS, et al. PRO 2014
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Biologic spacer
• Alloderm (Life cell)• Cadaveric human skin• Chemically processed to preserve the
structural and biologically active dermal matrix.
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Placement
• Laproscopically placed• 12 mm Hasson port placed in the
periunilical position• Two 5 mm ports and one 12 mm port
placed• Lysis of adhesions if necessary• Sheets of 8 x 16 cm sheets were folded
into a 3 layer sandwich and sewn at four corners
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Placement of Spacer
A B
C
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Results: Patients with Spacers
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Results: Net Change with Spacers
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Results: Radiation Delivered
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Results: Radiation Therapy Toxicity
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Tumor
GB
Omental fat
Alloderm
Alloderm
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Liver
Alloderm
Alloderm
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Duodenum
Alloderm
Small bowel
Alloderm
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Pre/Post Alloderm
Tumor
Bowel
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Plan
Alloderm
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Conclusions
• High dose radiation is an effective treatment for intrahepatic cholangiocarcinoma
• Biologic mesh spacers can allow patients not otherwise able to be treated to receive this therapy
• Biologic mesh spacers are associated with safe radiation treatments
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Acknowledgements
• Sam Yoon, MD• John Mullen, MD• Alex Haynes, MD• Christopher Crane, MD• Jennifer Wo, MD