Survival after Yttrium-90 resin microsphere... : Hepatology (original) (raw)

Hepatobiliary Malignancies

Survival after Yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: A European evaluation

Sangro, Bruno1,*; Carpanese, Livio2; Cianni, Roberto3; Golfieri, Rita4; Gasparini, Daniele5; Ezziddin, Samer6; Paprottka, Philipp M.7; Fiore, Francesco8; Van Buskirk, Mark9; Bilbao, Jose Ignacio10; Ettorre, Giuseppe Maria11; Salvatori, Rita12; Giampalma, Emanuela4; Geatti, Onelio13; Wilhelm, Kai14; Hoffmann, Ralf Thorsten7; Izzo, Francesco15; Iñarrairaegui, Mercedes1; Maini, Carlo Ludovico16; Urigo, Carlo3; Cappelli, Alberta17; Vit, Alessandro5; Ahmadzadehfar, Hojjat6; Jakobs, Tobias Franz7; Lastoria, Secondo18 on behalf of the European Network on Radioembolization with Yttrium-90 Resin Microspheres (ENRY)

1_Liver Unit, Clinica Universidad de Navarra and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBEREHD), Pamplona, Spain_

2_Department of Interventional Radiology, IFO Regina Elena National Cancer Institute, Rome, Italy_

3_Department of Interventional Radiology, S. M. Goretti Hospital, Latina, Italy_

4_Bologna University Hospital, Bologna, Italy_

5_Diagnostic and Interventional Radiology, Azienda Ospedaliera S. M. della Misericordia, Udine, Italy_

6_Department of Nuclear Medicine, Bonn University Hospital, Germany_

7_Department of Interventional Radiology, LMU University Hospital, Munich, Germany_

8_Onco Interventional Radiology, Pascale Cancer Institute, Napoli, Italy_

9_Data Reduction LLC, Chester, NJ_

10_Department of Interventional Radiology, University Clinic of Navarra, Pamplona, Spain_

11_General Surgery and Transplantation Unit, San Camillo Hospital, Rome, Italy_

12_Department of Nuclear Medicine, S. M. Goretti Hospital, Latina, Italy_

13_Departments of Nuclear Medicine, Azienda Ospedaliera S. M. della Misericordia, Udine, Italy_

14_Department of Radiology, Bonn University Hospital, Germany_

15_Department of Hepatobiliary Surgery, Pascale Cancer Institute, Naples, Italy_

16_Department of Nuclear Medicine, IFO Regina Elena National Cancer Institute, Rome, Italy_

17_Department of Medical Oncology, S. Orsola-Malpighi University Hospital, Bologna, Italy_

18_Department of Nuclear Medicine, Pascale Cancer Institute, Naples, Italy_

*Address reprint requests to: Liver Unit, Clinica Universidad de Navarra, Avda. Pio XII, 36. 31008-Pamplona, Spain

Email: [email protected]

Received 11 February 2011; accepted 12 May 2011

Potential conflict of interest: Drs. Sangro and Jakobs are on the speakers' bureau of Sirtex Medical. Dr. Buskirk is a consultant for Sirtex Medical.

A complete list of ENRY investigators is provided in the Acknowledgments.

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Additional Supporting Information may be found in the online version of this article.

Abstract

A multicenter analysis was conducted to evaluate the main prognostic factors driving survival after radioembolization using yttrium-90–labeled resin microspheres in patients with hepatocellular carcinoma at eight European centers. In total, 325 patients received a median activity of 1.6 GBq between September 2003 and December 2009, predominantly as whole-liver (45.2%) or right-lobe (38.5%) infusions. Typically, patients were Child-Pugh class A (82.5%), had underlying cirrhosis (78.5%), and had good Eastern Cooperative Oncology Group (ECOG) performance status (ECOG 0-1; 87.7%), but many had multinodular disease (75.9%) invading both lobes (53.1%) and/or portal vein occlusion (13.5% branch; 9.8% main). Over half had advanced Barcelona Clinic Liver Cancer (BCLC) staging (BCLC C, 56.3%) and one-quarter had intermediate staging (BCLC B, 26.8%). The median overall survival was 12.8 months (95% confidence interval, 10.9-15.7), which varied significantly by disease stage (BCLC A, 24.4 months [95% CI, 18.6-38.1 months]; BCLC B, 16.9 months [95% CI, 12.8-22.8 months]; BCLC C, 10.0 months [95% CI, 7.7-10.9 months]). Consistent with this finding, survival varied significantly by ECOG status, hepatic function (Child-Pugh class, ascites, and baseline total bilirubin), tumor burden (number of nodules, alpha-fetoprotein), and presence of extrahepatic disease. When considered within the framework of BCLC staging, variables reflecting tumor burden and liver function provided additional prognostic information. The most significant independent prognostic factors for survival upon multivariate analysis were ECOG status, tumor burden (nodules >5), international normalized ratio >1.2, and extrahepatic disease. Common adverse events were: fatigue, nausea/vomiting, and abdominal pain. Grade 3 or higher increases in bilirubin were reported in 5.8% of patients. All-cause mortality was 0.6% and 6.8% at 30 and 90 days, respectively. Conclusion: This analysis provides robust evidence of the survival achieved with radioembolization, including those with advanced disease and few treatment options. (HEPATOLOGY 2011;)

Abbreviations: BCLC, Barcelona Clinic Liver Cancer; CI, confidence interval; CTCAE, Common Terminology Criteria for Adverse Events; ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma; HR, hazard ratio; INR, international normalized ratio; 90Y, yttrium-90.