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Single center early experience with locoregional treatment for HCC following sofosbuvir-based HCV therapy: safety and efficacy
JVIR
’
Scientific Session
Wednesday
tumor burden. These factors may be helpful as selection criteria for anticipating which patients are most likely to benefit from empiric admission after TAE.
4:03 PM
Abstract No. 384
Promising efficacy with liver-directed therapies for the treatment of metastatic and unresectable hepatic sarcomas D. Pierce1, E. Monroe1, G. Johnson1, E. Loggers2, R. Jones2, S. Pollack2, S. Padia1; 1University of Washington Medical Center, Seattle, WA; 2Fred Hutchinson Cancer Research Center, Seattle, WA.
4:12 PM
Abstract No. 385
Pain palliation and radiographic local control of spinal metastases with percutaneous radiofrequency ablation and vertebral augmentation A. Wallace1, A. Tomasian2, T. Greenwood1, D. Vaswani1, R. Vyhmeister3, J. Jennings1; 1Mallinckrodt Institute of
S173
Radiology, St Louis, MO; 2University of Southern California, Los Angeles, CA; 3Washington University School of Medicine, St Louis, MO. Purpose: To evaluate the efficacy of combination radiofrequency ablation (RFA) and vertebral augmentation (VA) at achieving pain palliation and radiographic local control of spinal metastases. Materials: Medical records of all patients who underwent RFA and VA of spinal metastases between April 2012 and February 2015 were reviewed. Lesion characteristics were assessed on pre-procedure imaging. Procedural complications were documented according to the Society of Interventional Radiology classification (1). Pre- and post-procedure mean worst pain scores 1- and 4-weeks after treatment were measured using the Numeric Rating Scale (10-point scale) and compared. Post-treatment imaging was reviewed for radiographic evidence of tumor progression. Tumors treated with radiation therapy at any time were exclued from local tumor control assessment. Results: During the study period, 81 RFA treatments of 123 spinal metastases were performed. Vertebral augmentation was performed after 96% (118/123) of ablations. Eighty one percent (100/123) of metastases involved the posterior vertebral body, 28% (35/123) were associated with erosion of the posterior vertebral body cortex and 42% (52/123) involved the pedicles. The median pre-procedure pain score was 8.0. Clinically significant decreased median pain scores of 3.75 (Po0.0001) and 3.0 (Po0.0001) were reported at 1and 4-week follow-up, respectively. No major complications occurred related to RFA, and there were no instances of symptomatic cement extravasation. Post-treatment imaging of 61 tumors (50%; 61/123) was assessed for evidence of radiographic tumor progression. Of these, radiographic local tumor control rates were 90% (44/49) at 3 months, 76% (29/38) at 6 months, and 71% (22/31) at 1 year after treatment. Conclusions: Radiofrequency ablation and VA appears to be an effective treatment for pain palliation and local control of spinal metastases. Reference 1. Ahmed, M, Solbiati L, Brace CL, et al. Image-guided tumor ablation: standardization of terminology and reporting criteria–a 10-year update. Radiology 2014; 273(1):241-260.
4:21 PM
Abstract No. 386
Single center early experience with locoregional treatment for HCC following sofosbuvir-based HCV therapy: safety and efficacy N. Swinburne, C. Besa Correa, N. Tabori, A. Fischman, R. Patel, F. Nowakowski, R. Lookstein, E. Kim; Icahn School of Medicine at Mount Sinai, New York, NY. Purpose: The recent introduction of sofosbuvir-based therapy (SBT), namely sofosbuvir and combined ledipasvir-sofosbuvir (Sovaldi and Harvoni, respectively; Gilead Sciences, Foster City, CA), has shown high efficacy in achieving sustained virologic response for patients with chronic hepatitis C virus (HCV) infection. However, SBT may cause clinical and
WEDNESDAY: Scientific Sessions
Purpose: The outcome for patients with metastatic/ unresectable sarcoma is poor, with a median overall survival of 12-16 months. We sought to evaluate the efficacy and safety of liver-directed therapies for treating hepatic sarcomas. Materials: A retrospective review identified all patients with metastatic and unresectable hepatic sarcoma treated with TAE, TACE, radioembolization (RE), and percutaneous RFA between 2004 and 2015. RECIST response was assessed for the target lesion; survival was assessed via Kaplan-Meyer analysis. 29 patients were identified (median age 47, 62% male). Histologic subtypes were: 11 leiomyosarcoma, 7 angiosarcoma, 6 GIST, 3 hemangiopericytoma, 1 epithelioid hemangioendoethelioma and 1 Ewing sarcoma. 23 patients (79%) had previously undergone systemic therapy and were considered chemo-refractory. Results: 19 patients (66%) were treated electively; 10 (34%) were treated emergently to control acute hemorrhage from tumor rupture. Those treated electively underwent a total of 9 TAE, 25 TACE, 12 RE and 4 RFA. All procedures were well tolerated with no grade 3 or 4 adverse events. The most common toxicities were post-embolization syndrome (10%) and fatigue (7%). 3 (16%) showed complete response (CR), 10 (53%) partial response (PR) and 6 (32%) stable (SD) or progressive disease (PD). RE and RFA had the highest rates of CR in the target lesion with 2/8 (25%) RE patients and 1/2 (50%) RFA patients showing CR. 1-year survival was 89%, 2year survival 83%, 3-year survival 31%, and 7-year survival 16%. All emergently treated patients underwent TAE. Angiosarcoma was the most frequent histology in this subgroup (7, 70%). Based on RECIST criteria for the target lesion, 2 (20%) had PR and 5 (50%) had SD or PD. 3 (30%) of patients did not survive the initial hospitalization. 1-year survival was 20% and 2-year survival was 10%. Conclusions: Liver-directed therapies are safe and effective in the elective treatment of metastatic and unresectable liver sarcomas, achieving local control of the target lesion in 465% of cases. The highest rates of CR were seen with RE and RFA, suggesting that further assessment of these treatments is warranted.
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S174
’
Wednesday
Scientific Session
laboratory liver toxicities in a subset of patients. To date, no study has evaluated safety and efficacy of locoregional therapy (LRT) with radiofrequency ablation (RFA), transarterial chemoembolization (TACE) and radioembolization (TARE) during and after SBT. We present our early single center experience. Materials: Patients that underwent LRT with RFA, TACE and/or TARE after completing SBT or within 30 days of initiating SBT were retrospectively reviewed. Patient demographics and performance data were obtained from medical records. Toxicity was evaluated during sofosbuvir treatment and within 30 days of LRT using CTCAE criteria. Tumor response was evaluated using mRECIST criteria on all available follow-up CT/MRI. Results: Twenty-one patients (age 62 ± 6.3 y; ECOG 0:6, 1:14, 2:1; Child Pugh A:17, B:4) with HCC were treated between 2/ 2014 and 7/2015 with RFA (n¼5), TACE (n¼19) and TARE (n¼16) during or after sofosbuvir (n¼12) or ledipasvir-sofosbuvir (n¼9) therapy. Total SBT course was 12 weeks (n¼4) or 24 weeks (n¼16); 1 patient terminated SBT at 10 weeks due to persistent abdominal pain. AEs attributable to SBT included grade 1 (n¼1) and grade 2 (n¼1) hyperbilirubinemia, grade 2 thrombocytopenia (n¼1), grade 1 pancytopenia (n¼1) and grade 1 headache (n¼1). AEs within 30 days of LRT included grade 1 hypertransaminasemia (n¼1), grade 1 nausea (n¼2) and grade 1 abdominal pain (n¼2) after TACE and grade 1 fatigue (n¼1) after TARE. Objective response rate was 73% (CR:15, PR:4, SD:4, PD:3). Disease control rate was 88%. Conclusions: Locoregional therapy with RFA, TACE and TARE during or after sofosbuvir-based therapy for HCV is safe and effective. Treatment with SBT should not be delayed due to planned LRT for HCC. Continued study is required to evaluate long term efficacy and overall survival. Reference 1. Eric Lawitz, et al. Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. N Engl J Med 2013; 368(20):1878-1888.
Scientific Session 40 WEDNESDAY: Scientific Sessions
Nonvascular: Abscess, Bilary, and Chest
3:00 PM
Abstract No. 387
’ FEATURED ABSTRACT Histotripsy liquefaction and subsequent fineneedle aspiration of large hematomas: feasibility study W. Monsky1, T. Khokhlova2, T. Matula3; 1University of Washington Medical Center, Seattle, WA; 2University
JVIR
of Washington, Department of Applied Physics, Seattle, WA; 3University of Washington, Seattle, WA. Purpose: Abdominal and muscular hematomas can have serious clinical consequences including abdominal or extremity compartment syndrome, abscess formation, and Page Kidney. Large, acute/sub-acute, hematomas usually cannot be adequately evacuated with percutaneous drains due to their viscosity. Indwelling drains may result in infection of a previously sterile hematoma. Histotripsy is mechanical fractionation using successive high intenisty ultrasound pulses. The goal of this work was to evaluate histotripsy techniques for rapid ultrasound-guided liquefaction of large volume hematomas with subsequent 21 gauge needle aspiration. Materials: The histotripsy methods—cavitation histotripsy (CH) and boiling histotripsy (BH) or a combination thereof —were applied to liquefy in vitro hematoma phantoms, fresh bovine blood poured into 50 ml molds and allowed to clot. 1 and 1.5 MHz ultrasound transducers were developed with low duty cycles to prevent heating while allowing short treatment times. The large areas of liquefaction, created by translating the focus within the sample in a 2D rectangular grid, were subsequently aspirated with a 21 gauge needle. The contents of the lysate were analyzed by histology and by sizing in a Coulter counter. Results: The peak instantaneous power to achieve BH was lower (at 1.5 MHz) or equal to (1 MHz) to that required to initiate CH. BH lysis was 1.5-2 times larger than with CH. The lysates contained minute amount of debris larger than 70 um and 99% of particulates were smaller than 10 um. The contents of the large anechoic area of liquefaction produced by histotripsy were successfully aspirated using a 21 gauge needle under ultrasound guidance, yielding 8 cc (for 1.5 MHz treatment) to 30 cc (for 1 MHz) of lysate with less than10 minutes of histotripsy. CH-aided liquefaction was slower, but the areas of liquefacton were more regularly shaped, facilitating easier aspiration. Conclusions: Histotripsy is optimized for liquefaction of large extravascular hematomas allowing for rapid fine needle aspiration under ultrasound guidance, without the need for chronic indwelling catheters or open surgical evacuation.
3:09 PM
Wednesday, April 6, 2016 3:00 PM – 4:30 PM Room: 205/206
’
Abstract No. 388
Three-dimensional printing of an abdominal compression device to facilitate CT-fluoroscopyguided interventional procedures Y. Epelboym1, P. Shyn2, T. Kelil1, J. Chick3, N. Chauhan3, B. Ripley4, A. Hosny5, F. Scholz6; 1Brigham & Women’s Hospital, Boston, MA; 2Brigham & Women’s Hospital, Chestnut Hill, MA; 3Hospital of the University of Pennsylvania, Philadelphia, PA; 4University of Washington, Seattle, WA; 5Wyss Institute for Biologically Inspired Engineering, Cambridge, MA; 6Lahey Clinic, Burlington, MA. Purpose: Percutaneous biopsies or drainages of deep intraperitoneal or retroperitoneal targets may be problematic due to intervening critical structures or long skin-to-target
’
Scientific Session
Wednesday
tumor burden. These factors may be helpful as selection criteria for anticipating which patients are most likely to benefit from empiric admission after TAE.
4:03 PM
Abstract No. 384
Promising efficacy with liver-directed therapies for the treatment of metastatic and unresectable hepatic sarcomas D. Pierce1, E. Monroe1, G. Johnson1, E. Loggers2, R. Jones2, S. Pollack2, S. Padia1; 1University of Washington Medical Center, Seattle, WA; 2Fred Hutchinson Cancer Research Center, Seattle, WA.
4:12 PM
Abstract No. 385
Pain palliation and radiographic local control of spinal metastases with percutaneous radiofrequency ablation and vertebral augmentation A. Wallace1, A. Tomasian2, T. Greenwood1, D. Vaswani1, R. Vyhmeister3, J. Jennings1; 1Mallinckrodt Institute of
S173
Radiology, St Louis, MO; 2University of Southern California, Los Angeles, CA; 3Washington University School of Medicine, St Louis, MO. Purpose: To evaluate the efficacy of combination radiofrequency ablation (RFA) and vertebral augmentation (VA) at achieving pain palliation and radiographic local control of spinal metastases. Materials: Medical records of all patients who underwent RFA and VA of spinal metastases between April 2012 and February 2015 were reviewed. Lesion characteristics were assessed on pre-procedure imaging. Procedural complications were documented according to the Society of Interventional Radiology classification (1). Pre- and post-procedure mean worst pain scores 1- and 4-weeks after treatment were measured using the Numeric Rating Scale (10-point scale) and compared. Post-treatment imaging was reviewed for radiographic evidence of tumor progression. Tumors treated with radiation therapy at any time were exclued from local tumor control assessment. Results: During the study period, 81 RFA treatments of 123 spinal metastases were performed. Vertebral augmentation was performed after 96% (118/123) of ablations. Eighty one percent (100/123) of metastases involved the posterior vertebral body, 28% (35/123) were associated with erosion of the posterior vertebral body cortex and 42% (52/123) involved the pedicles. The median pre-procedure pain score was 8.0. Clinically significant decreased median pain scores of 3.75 (Po0.0001) and 3.0 (Po0.0001) were reported at 1and 4-week follow-up, respectively. No major complications occurred related to RFA, and there were no instances of symptomatic cement extravasation. Post-treatment imaging of 61 tumors (50%; 61/123) was assessed for evidence of radiographic tumor progression. Of these, radiographic local tumor control rates were 90% (44/49) at 3 months, 76% (29/38) at 6 months, and 71% (22/31) at 1 year after treatment. Conclusions: Radiofrequency ablation and VA appears to be an effective treatment for pain palliation and local control of spinal metastases. Reference 1. Ahmed, M, Solbiati L, Brace CL, et al. Image-guided tumor ablation: standardization of terminology and reporting criteria–a 10-year update. Radiology 2014; 273(1):241-260.
4:21 PM
Abstract No. 386
Single center early experience with locoregional treatment for HCC following sofosbuvir-based HCV therapy: safety and efficacy N. Swinburne, C. Besa Correa, N. Tabori, A. Fischman, R. Patel, F. Nowakowski, R. Lookstein, E. Kim; Icahn School of Medicine at Mount Sinai, New York, NY. Purpose: The recent introduction of sofosbuvir-based therapy (SBT), namely sofosbuvir and combined ledipasvir-sofosbuvir (Sovaldi and Harvoni, respectively; Gilead Sciences, Foster City, CA), has shown high efficacy in achieving sustained virologic response for patients with chronic hepatitis C virus (HCV) infection. However, SBT may cause clinical and
WEDNESDAY: Scientific Sessions
Purpose: The outcome for patients with metastatic/ unresectable sarcoma is poor, with a median overall survival of 12-16 months. We sought to evaluate the efficacy and safety of liver-directed therapies for treating hepatic sarcomas. Materials: A retrospective review identified all patients with metastatic and unresectable hepatic sarcoma treated with TAE, TACE, radioembolization (RE), and percutaneous RFA between 2004 and 2015. RECIST response was assessed for the target lesion; survival was assessed via Kaplan-Meyer analysis. 29 patients were identified (median age 47, 62% male). Histologic subtypes were: 11 leiomyosarcoma, 7 angiosarcoma, 6 GIST, 3 hemangiopericytoma, 1 epithelioid hemangioendoethelioma and 1 Ewing sarcoma. 23 patients (79%) had previously undergone systemic therapy and were considered chemo-refractory. Results: 19 patients (66%) were treated electively; 10 (34%) were treated emergently to control acute hemorrhage from tumor rupture. Those treated electively underwent a total of 9 TAE, 25 TACE, 12 RE and 4 RFA. All procedures were well tolerated with no grade 3 or 4 adverse events. The most common toxicities were post-embolization syndrome (10%) and fatigue (7%). 3 (16%) showed complete response (CR), 10 (53%) partial response (PR) and 6 (32%) stable (SD) or progressive disease (PD). RE and RFA had the highest rates of CR in the target lesion with 2/8 (25%) RE patients and 1/2 (50%) RFA patients showing CR. 1-year survival was 89%, 2year survival 83%, 3-year survival 31%, and 7-year survival 16%. All emergently treated patients underwent TAE. Angiosarcoma was the most frequent histology in this subgroup (7, 70%). Based on RECIST criteria for the target lesion, 2 (20%) had PR and 5 (50%) had SD or PD. 3 (30%) of patients did not survive the initial hospitalization. 1-year survival was 20% and 2-year survival was 10%. Conclusions: Liver-directed therapies are safe and effective in the elective treatment of metastatic and unresectable liver sarcomas, achieving local control of the target lesion in 465% of cases. The highest rates of CR were seen with RE and RFA, suggesting that further assessment of these treatments is warranted.
’
S174
’
Wednesday
Scientific Session
laboratory liver toxicities in a subset of patients. To date, no study has evaluated safety and efficacy of locoregional therapy (LRT) with radiofrequency ablation (RFA), transarterial chemoembolization (TACE) and radioembolization (TARE) during and after SBT. We present our early single center experience. Materials: Patients that underwent LRT with RFA, TACE and/or TARE after completing SBT or within 30 days of initiating SBT were retrospectively reviewed. Patient demographics and performance data were obtained from medical records. Toxicity was evaluated during sofosbuvir treatment and within 30 days of LRT using CTCAE criteria. Tumor response was evaluated using mRECIST criteria on all available follow-up CT/MRI. Results: Twenty-one patients (age 62 ± 6.3 y; ECOG 0:6, 1:14, 2:1; Child Pugh A:17, B:4) with HCC were treated between 2/ 2014 and 7/2015 with RFA (n¼5), TACE (n¼19) and TARE (n¼16) during or after sofosbuvir (n¼12) or ledipasvir-sofosbuvir (n¼9) therapy. Total SBT course was 12 weeks (n¼4) or 24 weeks (n¼16); 1 patient terminated SBT at 10 weeks due to persistent abdominal pain. AEs attributable to SBT included grade 1 (n¼1) and grade 2 (n¼1) hyperbilirubinemia, grade 2 thrombocytopenia (n¼1), grade 1 pancytopenia (n¼1) and grade 1 headache (n¼1). AEs within 30 days of LRT included grade 1 hypertransaminasemia (n¼1), grade 1 nausea (n¼2) and grade 1 abdominal pain (n¼2) after TACE and grade 1 fatigue (n¼1) after TARE. Objective response rate was 73% (CR:15, PR:4, SD:4, PD:3). Disease control rate was 88%. Conclusions: Locoregional therapy with RFA, TACE and TARE during or after sofosbuvir-based therapy for HCV is safe and effective. Treatment with SBT should not be delayed due to planned LRT for HCC. Continued study is required to evaluate long term efficacy and overall survival. Reference 1. Eric Lawitz, et al. Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. N Engl J Med 2013; 368(20):1878-1888.
Scientific Session 40 WEDNESDAY: Scientific Sessions
Nonvascular: Abscess, Bilary, and Chest
3:00 PM
Abstract No. 387
’ FEATURED ABSTRACT Histotripsy liquefaction and subsequent fineneedle aspiration of large hematomas: feasibility study W. Monsky1, T. Khokhlova2, T. Matula3; 1University of Washington Medical Center, Seattle, WA; 2University
JVIR
of Washington, Department of Applied Physics, Seattle, WA; 3University of Washington, Seattle, WA. Purpose: Abdominal and muscular hematomas can have serious clinical consequences including abdominal or extremity compartment syndrome, abscess formation, and Page Kidney. Large, acute/sub-acute, hematomas usually cannot be adequately evacuated with percutaneous drains due to their viscosity. Indwelling drains may result in infection of a previously sterile hematoma. Histotripsy is mechanical fractionation using successive high intenisty ultrasound pulses. The goal of this work was to evaluate histotripsy techniques for rapid ultrasound-guided liquefaction of large volume hematomas with subsequent 21 gauge needle aspiration. Materials: The histotripsy methods—cavitation histotripsy (CH) and boiling histotripsy (BH) or a combination thereof —were applied to liquefy in vitro hematoma phantoms, fresh bovine blood poured into 50 ml molds and allowed to clot. 1 and 1.5 MHz ultrasound transducers were developed with low duty cycles to prevent heating while allowing short treatment times. The large areas of liquefaction, created by translating the focus within the sample in a 2D rectangular grid, were subsequently aspirated with a 21 gauge needle. The contents of the lysate were analyzed by histology and by sizing in a Coulter counter. Results: The peak instantaneous power to achieve BH was lower (at 1.5 MHz) or equal to (1 MHz) to that required to initiate CH. BH lysis was 1.5-2 times larger than with CH. The lysates contained minute amount of debris larger than 70 um and 99% of particulates were smaller than 10 um. The contents of the large anechoic area of liquefaction produced by histotripsy were successfully aspirated using a 21 gauge needle under ultrasound guidance, yielding 8 cc (for 1.5 MHz treatment) to 30 cc (for 1 MHz) of lysate with less than10 minutes of histotripsy. CH-aided liquefaction was slower, but the areas of liquefacton were more regularly shaped, facilitating easier aspiration. Conclusions: Histotripsy is optimized for liquefaction of large extravascular hematomas allowing for rapid fine needle aspiration under ultrasound guidance, without the need for chronic indwelling catheters or open surgical evacuation.
3:09 PM
Wednesday, April 6, 2016 3:00 PM – 4:30 PM Room: 205/206
’
Abstract No. 388
Three-dimensional printing of an abdominal compression device to facilitate CT-fluoroscopyguided interventional procedures Y. Epelboym1, P. Shyn2, T. Kelil1, J. Chick3, N. Chauhan3, B. Ripley4, A. Hosny5, F. Scholz6; 1Brigham & Women’s Hospital, Boston, MA; 2Brigham & Women’s Hospital, Chestnut Hill, MA; 3Hospital of the University of Pennsylvania, Philadelphia, PA; 4University of Washington, Seattle, WA; 5Wyss Institute for Biologically Inspired Engineering, Cambridge, MA; 6Lahey Clinic, Burlington, MA. Purpose: Percutaneous biopsies or drainages of deep intraperitoneal or retroperitoneal targets may be problematic due to intervening critical structures or long skin-to-target