Research Reporting Standards for Radioembolization of Hepatic Malignancies
2011; Elsevier BV; Volume: 22; Issue: 3 Linguagem: Inglês
10.1016/j.jvir.2010.10.029
ISSN1535-7732
AutoresRiad Salem, Robert J. Lewandowski, Vanessa L. Gates, Charles Nutting, Ravi Murthy, Steven C. Rose, Michael C. Soulen, Jean-François H. Geschwind, Laura Kulik, Yun Hwan Kim, Carlo Spreafico, Marco Maccauro, Lourens Bester, Daniel B. Brown, Robert K. Ryu, Daniel Y. Sze, William S. Rilling, Kent T. Sato, Bruno Sangro, José Ignacio Bilbao, Tobias F. Jakobs, Samer Ezziddin, Suyash Kulkarni, Aniruddha Kulkarni, David Liu, David Valenti, Philip Hilgard, Gerald Antoch, Stefan Müller, Hamad Alsuhaibani, Mary F. Mulcahy, Marta Burrel, María Isabel Real, Stewart Spies, Abdulredha Esmail, Jean‐Luc Raoul, Étienne Garin, M. Johnson, Al B. Benson, Ricky A. Sharma, Harpreet Wasan, Bieke Lambert, Khairuddin Memon, Andrew S. Kennedy, Ahsun Riaz,
Tópico(s)Hepatitis B Virus Studies
ResumoRadioembolization is a field of interventional oncology that continues to evolve. The number of institutions adopting this approach is increasing; this trend is paralleled by a greater number of research investigations reported in the peer-reviewed literature. Therefore, developing standardization and reporting criteria therefore becomes of paramount importance in order to facilitate clear communications between investigators. The vehicle of a standards document provides the framework for reporting various aspects of the technique, including classification of methodology, descriptors of toxicities and complications, imaging guidance, and appropriate terminology that require specific attention when reporting clinical studies. It is the standpoint of the group that adherence to the recommendations will facilitate the main objective: improved precision and communication for reporting the various aspects of radioembolization. This approach should translate to more accurate comparison of data across centers and, ultimately, to enhanced research methodology. Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver; its incidence is increasing worldwide. It ranks as the sixth most common tumor and third most common cause of cancer-related mortality (1Parkin D.M. Bray F. Ferlay J. Pisani P. Global cancer statistics, 2002.CA Cancer J Clin. 2005; 55: 74-108Crossref PubMed Scopus (17151) Google Scholar, 2Bosch F.X. Ribes J. Diaz M. Cleries R. Primary liver cancer: worldwide incidence and trends.Gastroenterology. 2004; 127: S5-S16Abstract Full Text Full Text PDF PubMed Scopus (2116) Google Scholar). Primary liver tumors include HCC and intrahepatic cholangiocarcinoma. Surgical resection is preferred over transplantation and is considered potentially curative in patients with resectable HCC and normal liver function (3Michel J. Suc B. Montpeyroux F. et al.Liver resection or transplantation for hepatocellular carcinoma? Retrospective analysis of 215 patients with cirrhosis.J Hepatol. 1997; 26: 1274-1280Abstract Full Text PDF PubMed Scopus (146) Google Scholar). Transplantation is considered the gold standard for patients with unresectable HCC and whose disease is within the Milan criteria (4Mazzaferro V. Regalia E. Doci R. et al.Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis.N Engl J Med. 1996; 334: 693-699Crossref PubMed Scopus (5529) Google Scholar). Resection and transplantation have limited roles, given advanced disease (chronic liver disease and/or tumor extent) at presentation and limited organ availability (5Kulik L.M. Atassi B. van Holsbeeck L. et al.Yttrium-90 microspheres (TheraSphere(R)) treatment of unresectable hepatocellular carcinoma: downstaging to resection, RFA and bridge to transplantation.J Surg Oncol. 2006; 94: 572-586Crossref PubMed Scopus (259) Google Scholar, 6Lu D.S. Yu N.C. Raman S.S. et al.Radiofrequency ablation of hepatocellular carcinoma: treatment success as defined by histologic examination of the explanted liver.Radiology. 2005; 234: 954-960Crossref PubMed Scopus (318) Google Scholar, 7Maddala Y.K. Stadheim L. Andrews J.C. et al.Drop-out rates of patients with hepatocellular cancer listed for liver transplantation: outcome with chemoembolization.Liver Transpl. 2004; 10: 449-455Crossref PubMed Scopus (194) Google Scholar). Chemoembolization and radiofrequency ablation represent standard therapies in treating patients and serve as a bridge to transplantation in selected patients (8Lencioni R. Crocetti L. Radiofrequency ablation of liver cancer.Tech Vasc Interv Radiol. 2007; 10: 38-46Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar, 9Takayasu K. Arii S. Ikai I. et al.Prospective cohort study of transarterial chemoembolization for unresectable hepatocellular carcinoma in 8510 patients.Gastroenterology. 2006; 131: 461-469Abstract Full Text Full Text PDF PubMed Scopus (691) Google Scholar). Radioembolization has an emerging role in “bridging” patients within criteria by delaying tumor progression. It has also been shown to downstage disease beyond the Milan, to within, transplant criteria (10Carr B.I. Hepatic arterial 90yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients.Liver Transpl. 2004; 10: S107-S110Crossref PubMed Scopus (216) Google Scholar, 11Salem 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. 2005; 16: 1627-1639Abstract Full Text Full Text PDF PubMed Scopus (320) Google Scholar, 12Lewandowski R.J. Kulik L.M. Riaz A. et al.A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization.Am J Transplant. 2009; 9: 1920-1928Crossref PubMed Scopus (415) Google Scholar). A recent study has demonstrated that radioembolization leads to longer time-to-progression and better toxicity profile when compared with chemoembolization (13Salem R, Lewandowski RJ, Kulik L, et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology Epub ahead of print Oct 30 2010.Google Scholar). Patients with macrovascular tumor involvement have also exhibited evidence of clinical benefit after radioembolization (14Kulik L.M. Carr B.I. Mulcahy M.F. et al.Safety and efficacy of (90)Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis.Hepatology. 2007; 47: 71-81Crossref Scopus (472) Google Scholar). Worldwide, secondary liver tumors are more common than primary liver tumors (15Lewandowski R.J. Thurston K.G. Goin J.E. et al.90Y microsphere (TheraSphere) treatment for unresectable colorectal cancer metastases of the liver: response to treatment at targeted doses of 135-150 Gy as measured by [18F]fluorodeoxyglucose positron emission tomography and computed tomographic imaging.J Vasc Interv Radiol. 2005; 16: 1641-1651Abstract Full Text Full Text PDF PubMed Scopus (133) Google Scholar). Secondary liver tumors are managed by both surgical and nonsurgical methods. The role of radioembolization for secondary liver tumors is promising and it has been shown to be safe and efficacious in patients with secondary liver tumors from colorectal carcinoma, neuroendocrine tumors, and other primary tumors (16Gray B. Van Hazel G. Hope M. et al.Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer.Ann Oncol. 2001; 12: 1711-1720Crossref PubMed Scopus (432) Google Scholar, 17Rhee T.K. Lewandowski R.J. Liu D.M. et al.90Y radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience.Ann Surg. 2008; 247: 1029-1035Crossref PubMed Scopus (184) Google Scholar, 18Kennedy A.S. Dezarn W.A. McNeillie P. et al.Radioembolization for unresectable neuroendocrine hepatic metastases using resin 90Y-microspheres: early results in 148 patients.Am J Clin Oncol. 2008; 31: 271-279Crossref PubMed Scopus (321) Google Scholar, 19Sharma R.A. Van Hazel G.A. Morgan B. et al.Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy.J Clin Oncol. 2007; 25: 1099-1106Crossref PubMed Scopus (251) Google Scholar, 20Kennedy A.S. McNeillie P. Dezarn W.A. et al.Treatment parameters and outcome in 680 treatments of internal radiation with resin 90Y-microspheres for unresectable hepatic tumors.Int J Radiat Oncol Biol Phys. 2009; 74: 1494-1500Abstract Full Text Full Text PDF PubMed Scopus (180) Google Scholar, 21Mulcahy M.F. Lewandowski R.J. Ibrahim S.M. et al.Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres.Cancer. 2009; 115: 1849-1858Crossref PubMed Scopus (136) Google Scholar, 22Van Hazel G. Blackwell A. Anderson J. et al.Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer.J Surg Oncol. 2004; 88: 78-85Crossref PubMed Scopus (350) Google Scholar, 23Kennedy A.S. Salem R. Radioembolization (yttrium-90 microspheres) for primary and metastatic hepatic malignancies.Cancer J. 2010; 16: 163-175Crossref PubMed Scopus (72) Google Scholar). The International Working Group on Image-guided Tumor Ablation published a document entitled “Image-guided tumor ablation: standardization of terminology and reporting criteria” (24Goldberg S.N. Grassi C.J. Cardella J.F. et al.Image-guided tumor ablation: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2005; 16: 765-778Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar). The main objective was “improved precision and communication in this field that leads to more accurate comparison of technologies and results and ultimately to improved patient outcomes” (24Goldberg S.N. Grassi C.J. Cardella J.F. et al.Image-guided tumor ablation: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2005; 16: 765-778Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar). The publication of this document led to the publication of a document focused on catheter-directed therapies entitled “Transcatheter therapy for hepatic malignancy: standardization of terminology and reporting criteria” (25Brown D.B. Gould J.E. Gervais D.A. et al.Transcatheter therapy for hepatic malignancy: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2007; 18: 1469-1478Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar). A transcatheter therapy that is believed to have potential benefit from standardization of terminology and reporting criteria is radioembolization. This therapy is commonly used for patients diagnosed with primary and secondary liver malignancies. A comprehensive document standardizing the indications, techniques, multimodality treatment approaches, and dosimetry has been presented previously by the Radioembolization Brachytherapy Oncology Consortium (26Kennedy A. Nag S. Salem R. et al.Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: a consensus panel report from the radioembolization brachytherapy oncology consortium.Int J Radiat Oncol Biol Phys. 2007; 68: 13-23Abstract Full Text Full Text PDF PubMed Scopus (511) Google Scholar). The initial goals of the Working Group's proposal for standardization fall in line with the initiative of the Society of Interventional Radiology (SIR), which promotes interventional oncology. Along these lines, SIR’s Technology Assessment Committee has been charged with reviewing and commenting on the standardization of terminology and reporting criteria. Accordingly, the document has been modified in an attempt to align its contents with prior SIR standards and to address additional issues that have been raised by the Technology Assessment Committee. In essence, this independent review and ratification by the SIR Technology Assessment Committee of the previous reports represents a continuation of the collaborative initiative to consolidate and unite all investigators and clinicians practicing interventional oncology by providing a common language to describe therapies and outcomes (24Goldberg S.N. Grassi C.J. Cardella J.F. et al.Image-guided tumor ablation: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2005; 16: 765-778Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar, 25Brown D.B. Gould J.E. Gervais D.A. et al.Transcatheter therapy for hepatic malignancy: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2007; 18: 1469-1478Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar). Recognizing that the management of patients with liver tumors requires a multidisciplinary approach, it is recommended to use terms that are in accordance with all disciplines involved. The details and definitions reported in the prior documents pertaining to radioembolization have been incorporated into the present document. This document is designed for reporting research and is not intended for clinical procedural notes on individual patients. Although substantial technical jargon and marketing terminology appear in the peer-reviewed medical literature, these should not be used. Radioembolization is an image-guided transcatheter tumor therapy. Radioactive materials (radionuclide embedded in the carrier, attached to carrier surface, or in suspension with the carrier) are injected via feeding vessel(s) to the tumor(s) in an attempt to achieve cell death by delivering a high dose of focused radiation to the tumor. It is advised to use “radioembolization” instead of terms like “selective internal radiation therapy” or “transarterial radionuclide therapy.” The device manufacturer with the brand name of the device should be reported once in the Methods section. Subsequently treatment should be reference by the agent (eg, yttrium-90 [90Y], iodine-131 [131I], holmium-166 [166Ho]). Table 1 presents a brief overview of the available radioembolic devices worldwide. The following details also require description.Table 1Brief Description of Available Radioembolic DevicesNameTheraSphereSIR-Spheres131I-Lipiodol188Re HDD*- Lipiodol32P-GMSMilican166HoMSRadionuclide (symbol)Yttrium 90 (90Y)Yttrium 90 (90Y)Iodine 131 (131I)Rhenium 188 (188Re)Phosphorus 32 (32Llovet J.M. Fuster J. Bruix J. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma.Liver Transpl. 2004; 10: S115-S120Crossref PubMed Scopus (570) Google ScholarP)Holmium 166 (166Ho)Holmium 166 (166Ho)Half-life (h)64.264.2192.516.9342.726.826.8CarrierGlass microspheresResin microspheresIodized oilIodized oilGlass microspheresChitosanPoly (L-lactic acid)Carrier size (μm)20–3020–60NANA46–76NA25–35Note.— HDD = 4-hexadecyl-1,2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol; GMS = glass microspheres. Open table in a new tab Note.— HDD = 4-hexadecyl-1,2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol; GMS = glass microspheres. Presently, the following radionuclides are available: 90Y (TheraSphere [MDS Nordion, Ottawa, Ontario, Canada] and SIR-Spheres [Sirtex Medical, Lane Cove, Australia]), 131I (Lipiocis; CIS Bio International, Gif sur Yvette, France), rhenium-188 (188Re), phosphorus-32 (32P) (BrachySil; pSividia, Watertown, Massachusetts) and 166Ho. It is recommended to present these radionuclides as the name of the element (not necessarily capitalized) with a dash followed by the mass number or as a symbol with the mass number as a left-hand superscript to the symbol (eg, yttrium-90 or 90Y). The half-life should be presented in standard units of time (hours instead of days). It is also important to appropriately report the carrier of the radionuclide. Iodized oil, chitosan, and microspheres have been used as carriers for the radionuclides. Furthermore, the constituents of the microspheres (ie, resin or glass) should be described. The range of particle size (per the package insert) may be reported. As a result of the development of new radioactive materials, studies comparing different devices may be seen in the future. Thus, when reporting outcomes it is recommended to describe the device early in the manuscript, with emphasis on the radionuclide and the carrier, and define the abbreviations/terms that will be used for the device(s). It is preferred to use the term “procedure” rather than “operation” (24Goldberg S.N. Grassi C.J. Cardella J.F. et al.Image-guided tumor ablation: standardization of terminology and reporting criteria.J Vasc Interv Radiol. 2005; 16: 765-778Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar). A “procedure” refers to a single patient encounter for treatment of liver tumor(s). The term “treatment session” is synonymous with “procedure” but it is recommended to choose only one of these terms and use it uniformly throughout the manuscript. Multiple vials may be injected in one treatment session. The term “treatment cycle” consists of all procedures required to complete treatment of the tumor-bearing portion of the liver (not including pretreatment angiography). If a patient has bilobar disease, patients may need two procedures, constituting one treatment cycle. Therefore, a treatment cycle has been completed when all known disease has been treated. It is advised to use the term “progression” to refer to the appearance of new tumor (hepatic or extrahepatic) and for the reappearance of tumor in a previously treated area (local progression). A new treatment cycle may be initiated in case of progression. The number of patients in the study, the number of participating institutions, and patient numbers per institution must be provided. Age may be reported as a median and range. A baseline demographics table is of high importance, with appropriate presentation of parameters such as age, sex, and ethnicity. The risk factors for the development of the liver tumors should be reported. In case of HCC, the etiology and incidence of chronic liver disease should be reported (eg, hepatitis B, hepatitis C, alcohol). “Cryptogenic cirrhosis” is a term to describe cirrhosis without a clear etiology. The number/percentage of HCCs developing in the absence of cirrhosis should also be reported. In the case of secondary liver tumors, it is recommended to report the primary malignancy. Treatments used for the primary tumor should be reported (eg, history of chemotherapy/radiation therapy/surgery). It is also important to report any relevant comorbidities (eg, performance status > 0, cancer-related symptoms) (27Oken M.M. Creech R.H. Tormey D.C. et al.Toxicity and response criteria of the Eastern Cooperative Oncology Group.Am J Clin Oncol. 1982; 5: 649-655Crossref PubMed Scopus (7900) Google Scholar). Physical examination should be performed, and the performance status should preferably be reported according to the Eastern Cooperative Oncology Group score (Table 2). Alternatively, the Karnofsky score may be used. Whenever possible, the quality of life should be evaluated using validated instruments (eg, Functional Assessment of Cancer Therapy–General questionnaire or Functional Assessment of Cancer Therapy–Hep questionnaire for patients with HCC) at baseline and during each follow-up encounter.Table 2Eastern Cooperative Oncology Group Performance StatusStatusDescription0Asymptomatic and fully active1Symptomatic; fully ambulatory; restricted in physical strenuous activity2Symptomatic; ambulatory; capable of self-care; > 50% of waking hours are spent out of bed3Symptomatic; limited self-care; > 50% of time spent in bed, but not bedridden4Completely disabled; no self-care; 100% bedridden5Deceased Open table in a new tab These should include complete blood counts, prothrombin time/International Normalized Ratio, liver function tests, and tumor markers (eg, α-fetoprotein for HCC). At minimum, baseline bilirubin values and tumor marker values should be reported in one of two formats: (i) stratified by cutoff values into low or high groups (the rationale behind choosing these cutoff values should be clearly stated in the Methods section) or (i) as medians with 95% CIs. Imaging modalities including ultrasound, computed tomography (CT), magnetic resonance (MR) imaging, and functional imaging (positron emission tomography with and without CT attenuation correction, and single photon emission CT [SPECT]) are used to help diagnose the liver tumor and help determine whether patients are suitable candidates for this procedure. It is important to report the diagnosis of the liver tumor and to clearly define the diagnostic criteria used (ie, imaging, biopsy, or tumor markers). The distribution (unilobar/bilobar), number (eg, solitary or multifocal, with optional substratification of multifocal tumors), and size of tumors (stratified or median with 95% CI), and the presence of vascular invasion and/or extrahepatic metastases should be reported (28Inarrairaegui M. Martinez-Cuesta A. Rodriguez M. et al.Analysis of prognostic factors after yttrium-90 radioembolization of advanced hepatocellular carcinoma.Int J Radiat Oncol Biol Phys. 2010; 77: 1441-1448Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar). Caution should be exercised when reporting extrahepatic metastases in the form of lymphadenopathy in HCC; enlarged physiologic lymph nodes may be seen, particularly with hepatitis C–induced cirrhosis. The Bismuth/Couinaud segmentation system should be preferred over other systems when describing the location of tumors (29Couinaud C. Liver anatomy: portal (and suprahepatic) or biliary segmentation.Dig Surg. 1999; 16: 459-467Crossref PubMed Scopus (278) Google Scholar). Staging should be performed according to accepted staging systems for the disease. In the case of HCC, in which there is usually coexisting liver cirrhosis, it is also recommended to calculate the Child–Turcotte–Pugh score and report the classes. Some commonly used staging systems for HCC are the Okuda, Barcelona Clinic Liver Cancer, Cancer of the Liver Italian Program, and United Network for Organ Sharing staging systems (30Vauthey J.N. Ribero D. Abdalla E.K. et al.Outcomes of liver transplantation in 490 patients with hepatocellular carcinoma: validation of a uniform staging after surgical treatment.J Am Coll Surg. 2007; 204: 1016-1027Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar). The Child–Turcotte–Pugh class assesses liver function and should be reported (31Child C.G. Turcotte J.G. Surgery and portal hypertension.Major Probl Clin Surg. 1964; 1: 1-85PubMed Google Scholar). Furthermore, it is recommended to report findings based on a staging system that incorporates tumor characteristics only (eg, United Network for Organ Sharing staging system) or both liver function and tumor characteristics (eg, Barcelona Clinic Liver Cancer staging system) (32Llovet J.M. Fuster J. Bruix J. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma.Liver Transpl. 2004; 10: S115-S120Crossref PubMed Scopus (570) Google Scholar). Table 3 outlines the most commonly used classification systems for HCC. We can not mandate the use of one staging system over another as a result of limited data comparing the various staging systems (33Seo Y.S. Kim Y.J. Um S.H. et al.Evaluation of the prognostic powers of various tumor status grading scales in patients with hepatocellular carcinoma.J Gastroenterol Hepatol. 2008; 23: 1267-1275Crossref PubMed Scopus (13) Google Scholar, 34Helton W. Strasberg S. AHPBA/AJCC consensus conference on staging of hepatocellular carcinoma: rationale and overview of the conference.HPB (Oxford). 2003; 5: 238-242Crossref PubMed Scopus (16) Google Scholar).Table 3Classification Systems for HCCRequirements for CalculationScoreClass/StageCharacteristicsChild–Pugh Classification SystemTotal Bilirubin (mg/dL) < 21AChild–Pugh score 5–6 2–32 > 33Serum albumin (g/dL) > 3.51BChild–Pugh score 7–9 2.8–3.52 < 2.83INR < 1.71CChild–Pugh score ≥ 10 1.71–2.202 > 2.203Ascites None1 Suppressed with medication2 Refractory3Hepatic encephalopathy None1 Grade I/II (or suppressed with medication)2 Grade III/IV (or refractory)3Okuda Staging SystemTumor size ≤ 50% of liver0I0 Points > 50% of liver1Albumin (g/dL) ≥ 30II1–2 Points < 31Total bilirubin (mg/dL) < 30III3–4 Points ≥ 31Ascites Absent0 Present1Cancer of the Liver Italian Program Staging System(a) Child–Pugh class A00Sum of a, b, c, and d B1 C2(b) Tumor morphology Uninodular and extension ≤ 50%01Sum of a, b, c, and d Multinodular and extension ≤ 50%1 Massive or extension > 50%2(c) AFP < 40002Sum of a, b, c, and d ≥ 4001(d) PVT Absent03Sum of a, b, c, and d Present14Sum of a, b, c, and d5Sum of a, b, c, and d6Sum of a, b, c, and dBarcelona Clinic Liver Cancer Staging SystemPresence/absence of portal hypertensionBilirubin level (normal/elevated)Tumor characteristics (size, number, vascular invasion, extrahepatic spread)ECOG performance statusEarly stageA1Solitary tumor, no portal hypertension, normal bilirubin, ECOG PS 0, Child–Pugh A/BA2Solitary tumor, portal hypertension, normal bilirubin, ECOG PS 0, Child–Pugh A/BA3Solitary tumor, portal hypertension, elevated bilirubin, ECOG PS 0, Child–Pugh A/BA4Up to 3 tumors all < 3 cm, ECOG PS 0, Child–Pugh A/BIntermediate stageBMultinodular, ECOG PS 0, Child–Pugh A/BAdvanced stageCVascular invasion or extrahepatic spread, ECOG PS 1/2, Child–Pugh A/BEnd-stageDAny, ECOG PS 3/4, Child-Pugh CUNOS Staging SystemTumor characteristics (size, number, vascular invasion, extrahepatic spread)T1Solitary < 2 cmT2Solitary up to 5 cm or ≤ 3 tumors all up to 3 cmT3Solitary > 5 cm or ≤ 3 tumors with at least one > 3 cmT4a≥ 4 TumorsT4bVascular invasionN/MExtrahepatic metastases (nodal, N; other, M)Note.—AFP = α-fetoprotein; ECOG = Eastern Cooperative Oncology Group; INR = international normalized ratio; PVT = portal venous thrombosis. Open table in a new tab Note.—AFP = α-fetoprotein; ECOG = Eastern Cooperative Oncology Group; INR = international normalized ratio; PVT = portal venous thrombosis. Given the numerous types of liver metastases that might be treated, it is impractical to mandate staging based on all tumor types (eg, tumor/node/metastasis staging for colorectal cancer). It is, however, advised to stratify the study population by the presence or absence of extrahepatic disease at time of treatment as well as any exposure to systemic therapy. Stage at initial presentation of colorectal metastases may be reported. Patients with unresectable/inoperable liver tumors and liver-dominant disease are candidates for radioembolization. The indications and the absolute/relative contraindications may also be reported. Given the intra- and interinstitutional variability, it is impossible to strictly predefine a patient population that would be offered radioembolization. Thus, a brief description of the reason for choosing radioembolization over other treatments should be included. The intent of the therapy should be stated (eg, downstaging/bridging to curative therapies such as transplantation, palliation, or prolongation of survival). The Materials and Methods section should provide detail on the inclusion/exclusion criteria for the study. These details need to be explicit if the study uses prospective subject accrual. If applicable, a flowchart showing the stepwise selection (ie, exclusion) process starting from the source population to the study population should be presented. Exclusion may be done on the basis of advanced tumor characteristics (eg, extrahepatic metastases) and liver dysfunction (eg, bilirubin level greater than normal, > 2.0 mg/dL). This needs to be appropriately reported. All previous systemic and locoregional therapies that the patient has received for the liver tumor need appropriate description; this is important for context. Prior/concomitant therapy is more common in patients with secondary rather than primary liver tumors. When possible, prior/concomitant/subsequent systemic and locoregional therapies should be reported, including (i) nature of additive therapy, (ii) information on whether the additive therapy was performed as a part of a predefined protocol, (iii) rationale and (iv) timing of additive therapy, and (v) information on whether treatment was first-, second-, or third-line in nature. These specifications are required as additive therapies represent a confounding variable that may alter treatment effectiveness and may also have a role in extended survival or, alternatively, the development of complications. The panel recognizes the controversy over the definition of a line of systemic therapy. As a result, investigators are encouraged to define a line of systemic therapy for the purposes of reporting their study. Alternatively, reporting exposure to the cytotoxic chemotherapies (5-fluorouracil, oxaliplatin, irinotecan) and cytostatic biologic agents (eg, bevacizumab, cetuximab, panitumumab) separately is also acceptable. The pretreatment (ie, planning) angiography is an important step in radioembolization; this is discussed in detail in comprehensive manuscripts (35Salem R. Thurston K.G. Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 1—technical and methodologic considerations.J Vasc Interv Radiol. 2006; 17: 1251-1278Abstract Full Text Full Text PDF PubMed Scopus (502) Google Scholar, 36Salem 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. 2006; 17: 1571-1593Abstract Full Text Full Text PDF PubMed Scopus (168) Google Scholar, 37Salem R. Thurston K.G. Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 2—special topics.J Vasc Interv Radiol. 2006; 17: 1425-1439Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar, 38Salem R. Lewandowski R.J. Sato K.T. et al.Technical aspects of radioembolization with 90Y microspheres.Tech Vasc Interv Radiol. 2007; 10: 12-29Abstract Full Text Full Text PDF PubMed Scopus (101) Google Scholar, 39Liu D.M. Salem R. Bui J.T. et al.Angiographic considerations in patients undergoing liver-directed therapy.J Vasc Interv Radiol. 2005; 16: 911-935Abstract Full Text Full Text PD
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