title: Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma.
abstract: Conventional transarterial chemoembolization (cTACE) is used to treat patients with hepatocellular carcinoma (HCC). Radioembolization is a minimally invasive procedure that involves implantation of radioactive micron-sized particles loaded with yttrium-90 (Y90) inside the blood vessels that supply a tumor. We performed a randomized, phase 2 study to compare the effects of cTACE and Y90 radioembolization in patients with HCC.
  
  
  
  From October 2009 through October 2015, we reviewed patients with HCC of all Barcelona Clinic Liver Cancer (BCLC) stages for eligibility. Of these, 179 patients with BCLC stages A or B met our enrollment criteria and were candidates for cTACE or Y90 therapy. Patients were assigned randomly to groups that received Y90 therapy (n = 24; 50% Child-Pugh A) or cTACE (n = 21; 71% Child-Pugh A). The primary outcome was time to progression (TTP), evaluated by intention-to-treat analysis. Secondary outcomes included safety, rate of response (based on tumor size and necrosis criteria), and Kaplan-Meier survival time. We performed inverse probability of censoring weighting and competing risk analyses.
  
  
  
  Patients in the Y90 radioembolization group had significant longer median TTP (>26 mo) than patients in the cTACE group (6.8 mo; P = .0012) (hazard ratio, 0.122; 95% confidence interval [CI], 0.027-0.557; P = .007). This was confirmed by competing risk and inverse probability of censoring weighting analyses accounting for transplantation or death. A significantly greater proportion of patients in the cTACE group developed diarrhea (21%) than in the Y90 group (0%; P = .031) or hypoalbuminemia (58% in the cTACE group vs 4% in the Y90 group; P < .001). Similar proportions of patients in each group had a response to therapy, marked by necrosis (74% in the cTACE group vs 87% in the Y90 group) (P = .433). The median survival time, censored to liver transplantation, was 17.7 months for the cTACE group (95% CI, 8.3-not calculable) vs 18.6 months for the Y90 group (95% CI, 7.4-32.5) (P = .99).
  
  
  
  In a randomized phase 2 study of patients with HCC of BCLC stages A or B, we found Y90 radioembolization to provide significantly longer TTP than cTACE. Y90 radioembolization provides better tumor control and could reduce drop-out from transplant waitlists. ClinicalTrials.gov no. NCT00956930.
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois; Division of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, Illinois; Division of Transplant Surgery, Department of Surgery, Northwestern University, Chicago, Illinois. Electronic address: r-salem@northwestern.edu.
authors: Riad
authors: R
authors: Salem
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Andrew C
authors: AC
authors: Gordon
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Samdeep
authors: S
authors: Mouli
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Ryan
authors: R
authors: Hickey
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Joseph
authors: J
authors: Kallini
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Ahmed
authors: A
authors: Gabr
authors: Division of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors: Mary F
authors: MF
authors: Mulcahy
authors: Division of Transplant Surgery, Department of Surgery, Northwestern University, Chicago, Illinois.
authors: Talia
authors: T
authors: Baker
authors: Division of Transplant Surgery, Department of Surgery, Northwestern University, Chicago, Illinois.
authors: Michael
authors: M
authors: Abecassis
authors: Section of Body Imaging, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Frank H
authors: FH
authors: Miller
authors: Section of Body Imaging, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Vahid
authors: V
authors: Yaghmai
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Kent
authors: K
authors: Sato
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Kush
authors: K
authors: Desai
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois.
authors: Bartley
authors: B
authors: Thornburg
authors: Division of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors: Al B
authors: AB
authors: Benson
authors: Department of Preventive Medicine, Northwestern University, Chicago, Illinois.
authors: Alfred
authors: A
authors: Rademaker
authors: Division of Hepatology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors: Daniel
authors: D
authors: Ganger
authors: Division of Hepatology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors: Laura
authors: L
authors: Kulik
authors: Section of Interventional Radiology, Department of Radiology, Northwestern University, Chicago, Illinois; Division of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors: Robert J
authors: RJ
authors: Lewandowski
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000473:pathology* / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D003967:Diarrhea / Q000209:etiology; D018450:Disease Progression; D018572:Disease-Free Survival; D004998:Ethiodized Oil / Q000627:therapeutic use; D005260:Female; D006801:Humans; D034141:Hypoalbuminemia / Q000209:etiology; D057194:Intention to Treat Analysis; D008113:Liver Neoplasms / Q000473:pathology* / Q000628:therapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D009367:Neoplasm Staging; D011446:Prospective Studies; D015996:Survival Rate; D015021:Yttrium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D015021:Yttrium Radioisotopes; D004998:Ethiodized Oil
keywords: Chemoembolization; Liver Cancer; Radioembolization; Randomized Trial