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• W2340322059 abstract "See Article on Page 729 Transarterial chemoembolization (TACE) is the treatment of choice for patients with intermediate stage hepatocellular carcinoma (HCC), classified according to the Barcelona Clinic Liver Cancer staging system (BCLC B) 1. For a standard treatment, there is a remarkable degree of heterogeneity in the type of patients who undergo TACE in the method of administration and in the frequency and timing of the procedure. The classical patient is one whose liver function is no worse than Child B7, good performance status and who is unable to have surgery for any of a number of different reasons. These may include comorbid diseases, tumour extent, number and location. In addition, the lesions have to be large enough to preclude radiofrequency ablation. Patients with otherwise resectable lesions who have portal hypertension that precludes surgery may also be offered TACE. Similarly, patients with lesions that are not anatomically resectable despite absence of portal hypertension and even with preserved liver function are also offered TACE. TACE candidates may have a single lesion or multiple lesions. In addition, patients with BCLC stage A disease who have undergone prior treatment that has failed are also eligible for TACE. It is obvious therefore that standard indications for TACE allow a largely heterogeneous group of patients to be treated by the same method. In carefully selected patients, the median survival following TACE is more than 2 years, with prolonged survival documented 2, 3. Given the heterogeneity of the patient population, it is difficult to accurately assess what the prognosis might be for an individual patient. It is not surprising therefore that investigators would attempt to impose some rigour to the assessment of post-TACE prognosis. There have been several attempts to do so. One of the first was the assessment for retreatment with TACE (ART) score 4, consisting of albumin, bilirubin and tumour size. This score was intended to determine whether a second TACE procedure should be performed, or whether the prognosis was so poor that TACE was unlikely to prolong life significantly. The ART score was based on data collected just prior to the second TACE. Survival was assessed after the second TACE. The ART score therefore reflected the post-second TACE prognosis. Shortly thereafter, the HAP score 5 was described. This score was intended to predict the outcome of TACE using data prior to the first TACE. Modified HAP (mHAP), a modified version of hepatoma arterialization protocol (HAP) 6, included the variables from HAP, and added post-treatment radiologic response to TACE. This meant that it could only be used retrospectively, and not prior to the first TACE. Another modification, mHAP-II 7, used a similar set of variables, including albumin, bilirubin, alpha-foetoprotein and tumour size and number, and did not require an assessment of response to TACE. The variables were stratified as categorical variables, rather than continuous variables. In this edition of the journal, Cappelli et al. 8 describe yet another variation on the theme, by developing a scoring system that includes the same variables as mHAP-II, but used as continuous variables. They were able to develop a formula, now available on the web, to calculate the median survival that could be applied to individual patients using data from before the first TACE. They show that this score is superior to existing comparable scores, the HAP score and the mHAP-II score based on C statistics and the Akaike Information Criterion (The C statistic reflects differences in the area under the Receiver Operating Characteristic curve, and the Akaike information Criterion is an estimate of the quality of the different models being considered). The current model (mHAP-III) includes albumin, bilirubin and alpha-foetoprotein as variables in addition to tumour size and number. The inclusion of variables as continuous variables rather than categorical variables (except for tumour number) improves the accuracy of the model since stratifying data into categories is associated with loss of information. Patients with portal vein tumour thrombus were excluded. Some of the previous scores included patients with portal vein tumour thrombosis. The authors of this model decided to exclude these patients since portal vein thrombosis is the most adverse prognostic factor, and TACE is contraindicated in patients with portal vein thrombosis (although it continues to be used in such patients in many centres). It was felt that the weighting factors provided by including portal vein thrombosis would drown out any effect from other variables, making the score less useful. Two methods of TACE were used in this study 8, conventional TACE and drug-eluting beads (DEB)-TACE. Although different centres administer TACE differently, it is likely that the model holds for other methods of administration of TACE as well. There are no data to suggest that one method is superior to any other method of delivering TACE. However, one factor that may make the model less reliable is the follow-up treatment. In this study, TACE was repeated “on demand”, for residual or recurrent disease when new lesions appeared. Others use a different approach, e.g., TACE is repeated at fixed intervals until tumour eradication or untreatable progression. We are not told whether patients who failed TACE were offered alternative treatment, e.g., sorafenib. Thus, variations in post-TACE treatment may be a factor that affects the accuracy of the model in individual patients. This study also addresses, although indirectly, some of the potential limits of TACE by including tumour size and number. The effects of larger and multiple tumours on prognosis have been well documented 3, 7. The larger the tumour and the more lesions present, the less good the prognosis. However, there is less information on whether TACE improves survival in all candidates regardless of different extents of intrahepatic disease, and if so, but how much. There may be a subset of patients in whom most of the benefit is seen, while others derive less benefit. Cappelli et al. 8 provide a model that can begin to approach that question. Since both tumour number and tumour size have been included in this score, it implicitly takes into account the limitation on survival imparted by these variables. Furthermore, this score can also be used for propensity matching to compare TACE to other forms of treatment in, e.g., patients with a more limited prognosis. The authors were careful not to make a judgment about what median survival is so short that TACE is not worthwhile, or that some other less invasive treatment should be offered instead. This is left to the norms that might be developed in individual centres. No one would argue that a patient eligible for TACE who has a 50% or higher chance of surviving 5 years should receive TACE, but at some cut-off TACE might no longer be worthwhile. The web site that displays the form to do the calculation provides median survival at 1, 3 and 5 years. It does not use SI units, which limits the usefulness of the algorithm to the United States. It might be more helpful to also include a 2-year survival data point. There are other issues that might limit the usefulness of the way the outcomes are displayed. In playing around with the data collection form on the web, it becomes apparent that only extreme cases are associated with a very low post-TACE survival. The programme does not accept tumour number greater than 4. It cannot therefore be used to assess prognosis in patients with disease disseminated widely within the liver. The read-out from the model is not optimized (and perhaps cannot be) to provide patient level prognosis. The web site provides median survival and confidence intervals around the median. This is not helpful to patients. It would be more helpful to provide the range of survival duration. Patients know that providing a precise prognosis in terms of months is not possible, but median survival is not meaningful to them. Knowing what the upper and lower limits of survival is much more informative. Two issues are raised by this work. The first is can it be used to assess prognosis? Once validated externally, if the results hold up then it should be useful in this regard. The second issue is whether it can be used to assess who should not receive TACE because of too high a risk or too poor an outcome. In this regard, this study is less definitive. First, since the population treated in this study was seen in an academic centre, one can assume that patients perceived to be at high risk of complications were not treated with TACE. Therefore, the score cannot be used to exclude patients from TACE because of poor liver function. Standard clinical indications will still have to be used for this purpose. It is also not clear whether the score is capable of identifying patients in whom the post-TACE prognosis is dismal even if the patient meets standard criteria for TACE, nor whether the score provides information that cannot be assessed on clinical grounds. Put another way, it is not certain whether application of this score provides meaningful information that affects the initial treatment decision. This is not to say that the score should not be used, only that at present its sole use is in putting a number on the probable duration of survival. Financial support: None. Conflict of interest: The authors do not have any disclosures to report." @default.
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• W2340322059 date "2016-04-22" @default.
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• W2340322059 title "To TACE or not to TACE: that is the question" @default.
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