Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma

Gastroenterology

Volumn 151, Issue 6, 2016, Pages 1155-1163.e2

  Salem, Riad ^a   Gordon, Andrew C ^a   Mouli, Samdeep ^a   Hickey, Ryan ^a   Kallini, Joseph ^a   Gabr, Ahmed ^a   Mulcahy, Mary F ^a   Baker, Talia ^a   Abecassis, Michael ^a   Miller, Frank H ^a   Yaghmai, Vahid ^a   Sato, Kent ^a   Desai, Kush ^a   Thornburg, Bartley ^a   Benson, Al B ^a   Rademaker, Alfred ^a   Ganger, Daniel ^a   Kulik, Laura ^a   Lewandowski, Robert J ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Chemoembolization; Liver Cancer; Radioembolization; Randomized Trial

Indexed keywords

IODINATED POPPYSEED OIL; RADIOACTIVE MATERIAL; YTTRIUM 90; ANTINEOPLASTIC AGENT; ETHIODIZED OIL; YTTRIUM;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; ASCITES; BACTERIAL PERITONITIS; CANCER CONTROL; CANCER GROWTH; CANCER SURVIVAL; CHEMOEMBOLIZATION; CHILD PUGH SCORE; CLINICAL OUTCOME; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIARRHEA; DOSIMETRY; EMBOLIC PARTICLE; FATIGUE; FEMALE; HUMAN; HYPERBILIRUBINEMIA; HYPOALBUMINEMIA; INTENTION TO TREAT ANALYSIS; KAPLAN MEIER METHOD; LIVER CELL CARCINOMA; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MEDIAN SURVIVAL TIME; MINIMALLY INVASIVE PROCEDURE; OVERALL SURVIVAL; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RADIOEMBOLIZATION; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SURVIVAL TIME; TREATMENT RESPONSE; TUMOR NECROSIS; TUMOR VOLUME; ADVERSE EFFECTS; CANCER STAGING; CARCINOMA, HEPATOCELLULAR; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE COURSE; DISEASE FREE SURVIVAL; LIVER NEOPLASMS; MIDDLE AGED; NECROSIS; PATHOLOGY; SURVIVAL RATE;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, HEPATOCELLULAR; CHEMOEMBOLIZATION, THERAPEUTIC; DIARRHEA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; ETHIODIZED OIL; FEMALE; HUMANS; HYPOALBUMINEMIA; INTENTION TO TREAT ANALYSIS; LIVER NEOPLASMS; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; NECROSIS; NEOPLASM STAGING; PROSPECTIVE STUDIES; SURVIVAL RATE; YTTRIUM RADIOISOTOPES;

EID: 84997228944     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2016.08.029     Document Type: Article

References (38)

1. 1 Torre, L.A., Bray, F., Siegel, R.L., et al. Global cancer statistics, 2012. CA Cancer J Clin 65 (2015), 87–108.
2. 2 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines); hepatobiliary cancers, 2016.
3. 3 EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol 56 (2012), 908–943.
4. 4 Bruix, J., Sherman, M., Management of hepatocellular carcinoma: an update. Hepatology 53 (2011), 1020–1022.
5. 5 Lo, C.M., Ngan, H., Tso, W.K., et al. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology 35 (2002), 1164–1171.
6. 6 Llovet, J.M., Real, M.I., Montana, X., et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet 359 (2002), 1734–1739.
7. 7 Llovet, J.M., Bruix, J., Systematic review of randomized trials for unresectable hepatocellular carcinoma: chemoembolization improves survival. Hepatology 37 (2003), 429–442.
8. 8 Salem, R., Lewandowski, R.J., Kulik, L., et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology 140 (2011), 497–507.e2.
9. 9 Salem, R., Miller, F.H., Yaghmai, V., et al. Response assessment methodologies in hepatocellular carcinoma: complexities in the era of local and systemic treatments. J Hepatol 58 (2013), 1260–1262.
10. 10 Gaba, R.C., Lewandowski, R.J., Kulik, L.M., et al. Radiation lobectomy: preliminary findings of hepatic volumetric response to lobar yttrium-90 radioembolization. Ann Surg Oncol 16 (2009), 1587–1596.
11. 11 Vouche, M., Lewandowski, R.J., Atassi, R., et al. Radiation lobectomy: time-dependent analysis of future liver remnant volume in unresectable liver cancer as a bridge to resection. J Hepatol 59 (2013), 1029–1036.
12. 90Y radioembolization: implementing a new treatment paradigm. Eur J Nucl Med Mol Imaging 43 (2016), 2353–2359.
13. 13 Kulik, L.M., Carr, B.I., Mulcahy, M.F., et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology 47 (2008), 71–81.
14. 14 Oliveri, R.S., Wetterslev, J., Gluud, C., Transarterial (chemo)embolisation for unresectable hepatocellular carcinoma. Cochrane Database Syst Rev, 3, 2011, CD004787.
15. 15 Ray, C.E. Jr., Haskal, Z.J., Geschwind, J.F., et al. The use of transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma: a response to the Cochrane Collaboration review of 2011. J Vasc Interv Radiol 22 (2011), 1693–1696.
16. 16 Llovet, J.M., Di Bisceglie, A.M., Bruix, J., et al. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 100 (2008), 698–711.
17. 17 Wald, C., Russo, M.W., Heimbach, J.K., et al. New OPTN/UNOS policy for liver transplant allocation: standardization of liver imaging, diagnosis, classification, and reporting of hepatocellular carcinoma. Radiology 266 (2013), 376–382.
18. 18 Salem, R., Lewandowski, R.J., Atassi, B., et al. Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): safety, tumor response, and survival. J Vasc Interv Radiol 16 (2005), 1627–1639.
19. 19 Murthy, R., Nunez, R., Szklaruk, J., et al. Yttrium-90 microsphere therapy for hepatic malignancy: devices, indications, technical considerations, and potential complications. Radiographics 25:Suppl 1 (2005), S41–S55.
20. 20 Salem, R., Thurston, K.G., Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol 17 (2006), 1571–1593.
21. 21 Common Terminology Criteria for Adverse Events v4.0 NCI, NIH, DHHS. May 29, 2009.
22. 22 Riaz, A., Miller, F.H., Kulik, L.M., et al. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA 303 (2010), 1062–1069.
23. 23 Hernan, M.A., Brumback, B., Robins, J.M., Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology 11 (2000), 561–570.
24. 24 Gooley, T.A., Leisenring, W., Crowley, J., et al. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med 18 (1999), 695–706.
25. 25 Alemao, E., Rajagopalan, S., Yang, S., et al. Inverse probability weighting to control for censoring in a post hoc analysis of quality-adjusted survival data from a clinical trial of temsirolimus for renal cell carcinoma. J Med Econ 14 (2011), 245–252.
26. 26 Willems, S., Schat, A., van Noorden, M.S., et al. Correcting for dependent censoring in routine outcome monitoring data by applying the inverse probability censoring weighted estimator. Stat Methods Med Res, 2016 http://dx.doi.org/10.1177/0962280216628900.
27. 27 Gray, R.J., A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 16 (1988), 1141–1154.
28. 28 Proschan, M.A., Lan, K.G., Wittes, J.T., Statistical monitoring of clinical trials: a unified approach. 2006, Springer Science & Business Media, New York.
29. 29 Jitlal, M., Khan, I., Lee, S.M., et al. Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies. Br J Cancer 107 (2012), 910–917.
30. 30 Kooby, D.A., Egnatashvili, V., Srinivasan, S., et al. Comparison of yttrium-90 radioembolization and transcatheter arterial chemoembolization for the treatment of unresectable hepatocellular carcinoma. J Vasc Interv Radiol 21 (2010), 224–230.
31. 31 Seyal, A.R., Gonzalez-Guindalini, F.D., Arslanoglu, A., et al. Reproducibility of mRECIST in assessing response to transarterial radioembolization therapy in hepatocellular carcinoma. Hepatology 62 (2015), 1111–1121.
32. 32 Hamoui, N., Minocha, J., Memon, K., et al. Prophylactic embolization of the gastroduodenal and right gastric arteries is not routinely necessary before radioembolization with glass microspheres. J Vasc Interv Radiol 24 (2013), 1743–1745.
33. 33 Buyse, M., Sargent, D.J., Saad, E.D., Survival is not a good outcome for randomized trials with effective subsequent therapies. J Clin Oncol 29 (2011), 4719–4720.
34. 34 Lewandowski, R.J., Mulcahy, M.F., Kulik, L.M., et al. Chemoembolization for hepatocellular carcinoma: comprehensive imaging and survival analysis in a 172-patient cohort. Radiology 255 (2010), 955–965.
35. 35 Lencioni, R., Llovet, J.M., Han, G., et al. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol 64 (2016), 1090–1098.
36. 36 Kudo, M., Imanaka, K., Chida, N., et al. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer 47 (2011), 2117–2127.
37. 37 Vouche, M., Habib, A., Ward, T.J., et al. Unresectable solitary hepatocellular carcinoma not amenable to radiofrequency ablation: multicenter radiology-pathology correlation and survival of radiation segmentectomy. Hepatology 60 (2014), 192–201.
38. 38 Padia, S.A., Kwan, S.W., Roudsari, B., et al. Superselective yttrium-90 radioembolization for hepatocellular carcinoma yields high response rates with minimal toxicity. J Vasc Interv Radiol 25 (2014), 1067–1073.