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Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma.

ABSTRACT: Chemoembolization is one of several standards of care treatment for hepatocellular carcinoma (HCC). Radioembolization with Yttrium-90 microspheres is a novel, transarterial approach to radiation therapy. We performed a comparative effectiveness analysis of these therapies in patients with HCC.We collected data from 463 patients who were treated with transarterial locoregional therapies (chemoembolization or radioembolization) over a 9-year period. We excluded patients who were not appropriate for comparison and analyzed data from 245 (122 who received chemoembolization and 123 who received radioembolization). Patients were followed for signs of toxicity; all underwent imaging analysis at baseline and follow-up time points. Overall survival was the primary outcome measure. Secondary outcomes included safety, response rate, and time-to-progression. Uni- and multivariate analyses were performed.Abdominal pain and increased transaminase activity were more frequent following chemoembolization (P < .05). There was a trend that patients treated with radioembolization had a higher response rate than with chemoembolization (49% vs 36%, respectively, P = .104). Although time-to-progression was longer following radioembolization than chemoembolization (13.3 months vs 8.4 months, respectively, P = .046), median survival times were not statistically different (20.5 months vs 17.4 months, respectively, P = .232). Among patients with intermediate-stage disease, survival was similar between groups that received chemoembolization (17.5 months) and radioembolization (17.2 months, P = .42).Patients with HCC treated by chemoembolization or radioembolization with Yttrium-90 microspheres had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemoembolization. Post hoc analyses of sample size indicated that a randomized study with > 1000 patients would be required to establish equivalence of survival times between patients treated with these two therapies.

SUBMITTER: Salem R

PROVIDER: S-EPMC3129335 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma.

Salem Riad R Lewandowski Robert J RJ Kulik Laura L Wang Edward E Riaz Ahsun A Ryu Robert K RK Sato Kent T KT Gupta Ramona R Nikolaidis Paul P Miller Frank H FH Yaghmai Vahid V Ibrahim Saad M SM Senthilnathan Seanthan S Baker Talia T Gates Vanessa L VL Atassi Bassel B Newman Steven S Memon Khairuddin K Chen Richard R Vogelzang Robert L RL Nemcek Albert A AA Resnick Scott A SA Chrisman Howard B HB Carr James J Omary Reed A RA Abecassis Michael M Benson Al B AB Mulcahy Mary F MF

Gastroenterology 20101030 2

<h4>Background & aims</h4>Chemoembolization is one of several standards of care treatment for hepatocellular carcinoma (HCC). Radioembolization with Yttrium-90 microspheres is a novel, transarterial approach to radiation therapy. We performed a comparative effectiveness analysis of these therapies in patients with HCC.<h4>Methods</h4>We collected data from 463 patients who were treated with transarterial locoregional therapies (chemoembolization or radioembolization) over a 9-year period. We exc ...[more]

PMID: 21044630

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Project description:Background & aimsConventional 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.MethodsFrom 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.ResultsPatients 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).ConclusionsIn 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.

Project description:To evaluate and compare outcome of stereotactic body radiation therapy (SBRT), yttrium-90 radioembolization, radiofrequency ablation (RFA), or transarterial chemoembolization (TACE) as bridge to liver transplant (LT) in patients with hepatocellular carcinoma.We retrospectively reviewed patients treated at our institution with SBRT, TACE, RFA, or yttrium-90 as bridge to LT between 2006 and 2013. We analyzed radiologic and pathologic response and rate of failure after bridge therapy. Toxicities were reported using Common Terminology Criteria for Adverse Events, 4.0. Kaplan-Meier method was used to calculate disease-free survival (DFS) and overall survival after LT.Sixty patients with a median age 57.5 years (range, 44-70) met inclusion criteria. Thirty-one patients (50.7%) had hepatitis C cirrhosis, 14 (23%) alcoholic cirrhosis, and 8 (13%) nonalcoholic steatohepatitis cirrhosis. Patients received a total of 79 bridge therapies: SBRT (n = 24), TACE (n = 37), RFA (n = 9), and Y90 (n = 9). Complete response (CR) was 25% for TACE, 8.6% for SBRT, 22% for RFA, and 33% for Y90. Grade 3 or 4 acute toxicity occurred following TACE (n = 4) and RFA (n = 2). Transplant occurred at a median of 7.4 months after bridge therapy. Pathological response among 57 patients was 100% necrosis (n = 23, 40%), >50% necrosis (n = 20, 35%), <50% necrosis (n = 9, 16%), and no necrosis (n = 5, 9%). Pathologic complete response was as follows: SBRT (28.5%), TACE (41%), RFA (60%), Y90 (75%), and multiple modalities (33%). At a median follow-up of 35 months, 7 patients had recurrence after LT. DFS was 85.8% and overall survival was 79% at 5 years.All bridge therapies demonstrated good pathological response and DFS after LT. SBRT and Y90 demonstrated significantly less grade ≥3 acute toxicity. Choice of optimal modality depends on tumor size, pretreatment bilirubin level, Child-Pugh status, and patient preference. Such a decision is best made at a multidisciplinary tumor board as is done at our institution.

Project description:PURPOSE:To assess the predictive value of volumetric apparent diffusion coefficient (vADC) histogram quantification obtained before and 6?weeks (6w) post-treatment for assessment of hepatocellular carcinoma (HCC) response to 90Yttrium radioembolization (RE). METHODS:In this retrospective study, 22 patients (M/F 15/7, mean age 65y) who underwent lobar RE were included between October 2013 and November 2014. All patients underwent routine liver MRI pre-treatment and 6w after RE. Two readers assessed index tumor response at 6?months after RE in consensus, using mRECIST criteria. vADC histogram parameters of index tumors at baseline and 6w, and changes in vADC (?vADC) histogram parameters were calculated. The predictive value of ADC metrics was assessed by logistic regression with stepwise parameter selection and ROC analyses. RESULTS:Twenty two HCC lesions (mean size 3.9?±?2.9?cm, range 1.2-12.3?cm) were assessed. Response at 6?months was as follows: complete response (CR, n?=?6), partial response (PR, n?=?3), stable disease (SD, n?=?12) and progression (PD, n?=?1). vADC median/mode at 6w (1.81-1.82 vs. 1.29-1.35?×?10-?3?mm2/s) and ?vADC median/max (27-44% vs. 0-10%) were significantly higher in CR/PR vs. SD/PD (p?=?0.011-0.036), while there was no significant difference at baseline. Logistic regression identified vADC median at 6w as an independent predictor of response (CR/PR) with odds ratio (OR) of 3.304 (95% CI: 1.099-9.928, p?=?0.033) and AUC of 0.77. ?vADC mean was identified as an independent predictor of CR with OR of 4.153 (95%CI: 1.229-14.031, p?=?0.022) and AUC of 0.91. CONCLUSION:Diffusion histogram parameters obtained at 6w and early changes in ADC from baseline are predictive of subsequent response of HCCs treated with RE, while pre-treatment vADC histogram parameters are not. These results need confirmation in a larger study. TRIAL REGISTRATION:This retrospective study was IRB-approved and the requirement for informed consent was waived.

Dataset Information

Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma.

Publications

Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma.

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