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Low accuracy of non-invasive tests for assessing residual cirrhosis in hepatitis C patients with a sustained virological response
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Abstracts / Digestive and Liver Disease 46 (2014) e1–e17
Conclusion: Hepatic resection may result in net survival benefit for HCC patients regardless BCLC stage, provided that technical feasibility and oncological radicality are guaranteed. http://dx.doi.org/10.1016/j.dld.2014.01.036 OC-32 A REGRET-BASED APPROACH TO CHOOSE BETWEEN TRANS-CATHETER ARTERIAL EMBOLIZATION AND HEPATIC RESECTION FOR INTERMEDIATE HEPATOCELLULAR CARCINOMA A. Cucchetti 1 , B. Djulbegovic 2 , F. Piscaglia 1 , A. Tsalatsanis 2 , A. Vitale 3 , I. Hozo 4 , A. Pecorelli 1 , M. Cescon 1 , G. Ercolani 1 , F. Tuci 3 , U. Cillo 3 , A.D. Pinna 1 1 Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Alma Mater Studiorum – University of Bologna, Bologna, Italy 2 Division of Evidence-based Medicine, Department of Internal Medicine, University of South Florida & H. Lee Moffitt Cancer Center & Research Institute 3 Department of General Surgery and Organ Transplantation, Hepatobiliary Surgery and Liver, Transplant Unit, University of Padua, Italy 4 Department of Mathematics and Actuarial Science, Indiana University Northwest, Gary, IN, USA
Introduction: Trans-catheter arterial chemo-embolization (TACE) is the first-line therapy recommended by western guidelines for intermediate hepatocellular carcinoma (HCC); however, in clinical practice, such patients are often referred to surgical teams for evaluation and treatment. After making a decision under uncertainty, physicians may discover that the alternative approach would have been preferable, imparting a sense of regret. Regret theory postulates that the optimal choice would be the one associated with the least amount of regret, in the case it is proven wrong. Aim: To apply regret theory to the decision-making of treatment of intermediate HCC. Methods: Data from 247 cirrhotic patients, resected for intermediate HCC, were used to build a prognostic model and to compute a regret decision-curve analysis (DCA) integrating physician’s preferences expressed in terms of regret associated with surgery and TACE choices. Physician’s treatment preferences were indicated by a threshold probability (Pt ) at which the physician is uncertain whether or not perform surgery. A survey among 40 hepatologists and surgeons regarding three hypothetical clinical cases was performed to assess if the physicians’ preferences cluster within relatively narrow domains. Results: The 3- and 5-year overall survival rates after surgery were 48.7% and 33.8%, respectively. Child–Pugh score, tumor number and presence of oesophageal varices were independent predictors of overall survival after hepatectomy (P < 0.05). Regret DCA showed that the use of the prediction model was associated with the least amount of regret until Pt = 70%, above which TACE of all patients was the least regretful strategy. The survey pointed to, on average, a significant separation among physicians’ preferences, pointing to the need for separate elicitation of individual preferences of each decision-maker. However, the use of regret DCA uniformed final decisions. Conclusions: Regret theory provides a new perspective for treatment-related decisions and can be applied in the setting of treatment of intermediate HCC. http://dx.doi.org/10.1016/j.dld.2014.01.037
OC-33 LOW ACCURACY OF NON-INVASIVE TESTS FOR ASSESSING RESIDUAL CIRRHOSIS IN HEPATITIS C PATIENTS WITH A SUSTAINED VIROLOGICAL RESPONSE E. Degasperi 1 , M. Fraquelli 2 , E. Grassi 1 , R. D’Ambrosio 1 , A. Aghemo 1 , M. Colombo 1 1 Centro A.M. e A. Migliavacca, First Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy 2 Second Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy
Background: A sustained virological response (SVR) to anti-HCV therapy can result in fibrosis and cirrhosis regression. A recent study demonstrated that the accuracy of transient elastography (TE) in assessing cirrhosis regression after an SVR is low, while the performance of other non-invasive tests is still unclear. Aim: To investigate the accuracy of non-invasive tests for assessing residual cirrhosis in HCV patients after an SVR. Methods: All HCV patients with a pre-treatment histological diagnosis of cirrhosis and available post-SVR liver biopsies had residual liver fibrosis assessed through the following noninvasive methods: APRI, CDS, Fib4, FibroQ, Forns score, Guci Index, King score, Lok Index, PLF. Liver fibrosis staged according to the METAVIR score was the reference standard. The performances of non-invasive tests to diagnose residual cirrhosis were calculated using receiver operating characteristic (ROC) curves analysis. Results: 20 out of 33 patients (61%) included in the study had cirrhosis regression after 61 (48–104) months from an SVR. The overall diagnostic accuracy of all the noninvasive serum panels analyzed was suboptimal as indicated by the AUROC values and the operative characteristics of the tests. None of these tests is useful in identifying patients with residual cirrhosis when using both the cut-off indicated by the literature (bold) and the cut off with the best sensitivity and specificity derived from the ROC curves (Table 1). Table 1 Test
Cut off
Sensitivity
Specificity
LR +
LR-
AUROC
APRI* CDS*
>0.2
84
30
1.2
0.5
0.58
(0.39–0.75)
>5 >3.25 >2.3 >2.6 >5.2 >6.9 >5 >0.26 >0.52 >16.7 >10.1 >0.5 >2.98 >2.6
46 15 31 85 46 23 38 76 38 15 46 30 31 58
75 99 95 25 90 90 55 30 85 99 85 95 95 90
1.8 15 6.1 1.1 4.6 2.3 0.8 1.1 2.5 15 3.1 6.1 6.5 5.8
0.6 0.8 0.7 0.6 0.60 0.8 1.1 0.7 0.7 0.8 0.6 0.73 0.7 0.4
0.60 0.59
(0.41–0.76) (0.41–0.76)
Fib 4 Fibro Q Forns score Guci index King score Lok index PLF *
95% CI
0.61
(0.42–0.78)
0.52
(0.34–0.70)
0.57
(0.39–0.74)
0.59
(0.40–0.75)
0.60 0.75
(0.42–0.77) (0.57–0.89)
All the patients had values lower than the standard cut off.
Conclusions: Most of non-invasive serologic tests are not accurate in assessing fibrosis stage and identifying cirrhotics after an SVR. Histological evaluation through liver biopsy still remains the gold standard in these patients. http://dx.doi.org/10.1016/j.dld.2014.01.038
Abstracts / Digestive and Liver Disease 46 (2014) e1–e17
Conclusion: Hepatic resection may result in net survival benefit for HCC patients regardless BCLC stage, provided that technical feasibility and oncological radicality are guaranteed. http://dx.doi.org/10.1016/j.dld.2014.01.036 OC-32 A REGRET-BASED APPROACH TO CHOOSE BETWEEN TRANS-CATHETER ARTERIAL EMBOLIZATION AND HEPATIC RESECTION FOR INTERMEDIATE HEPATOCELLULAR CARCINOMA A. Cucchetti 1 , B. Djulbegovic 2 , F. Piscaglia 1 , A. Tsalatsanis 2 , A. Vitale 3 , I. Hozo 4 , A. Pecorelli 1 , M. Cescon 1 , G. Ercolani 1 , F. Tuci 3 , U. Cillo 3 , A.D. Pinna 1 1 Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Alma Mater Studiorum – University of Bologna, Bologna, Italy 2 Division of Evidence-based Medicine, Department of Internal Medicine, University of South Florida & H. Lee Moffitt Cancer Center & Research Institute 3 Department of General Surgery and Organ Transplantation, Hepatobiliary Surgery and Liver, Transplant Unit, University of Padua, Italy 4 Department of Mathematics and Actuarial Science, Indiana University Northwest, Gary, IN, USA
Introduction: Trans-catheter arterial chemo-embolization (TACE) is the first-line therapy recommended by western guidelines for intermediate hepatocellular carcinoma (HCC); however, in clinical practice, such patients are often referred to surgical teams for evaluation and treatment. After making a decision under uncertainty, physicians may discover that the alternative approach would have been preferable, imparting a sense of regret. Regret theory postulates that the optimal choice would be the one associated with the least amount of regret, in the case it is proven wrong. Aim: To apply regret theory to the decision-making of treatment of intermediate HCC. Methods: Data from 247 cirrhotic patients, resected for intermediate HCC, were used to build a prognostic model and to compute a regret decision-curve analysis (DCA) integrating physician’s preferences expressed in terms of regret associated with surgery and TACE choices. Physician’s treatment preferences were indicated by a threshold probability (Pt ) at which the physician is uncertain whether or not perform surgery. A survey among 40 hepatologists and surgeons regarding three hypothetical clinical cases was performed to assess if the physicians’ preferences cluster within relatively narrow domains. Results: The 3- and 5-year overall survival rates after surgery were 48.7% and 33.8%, respectively. Child–Pugh score, tumor number and presence of oesophageal varices were independent predictors of overall survival after hepatectomy (P < 0.05). Regret DCA showed that the use of the prediction model was associated with the least amount of regret until Pt = 70%, above which TACE of all patients was the least regretful strategy. The survey pointed to, on average, a significant separation among physicians’ preferences, pointing to the need for separate elicitation of individual preferences of each decision-maker. However, the use of regret DCA uniformed final decisions. Conclusions: Regret theory provides a new perspective for treatment-related decisions and can be applied in the setting of treatment of intermediate HCC. http://dx.doi.org/10.1016/j.dld.2014.01.037
OC-33 LOW ACCURACY OF NON-INVASIVE TESTS FOR ASSESSING RESIDUAL CIRRHOSIS IN HEPATITIS C PATIENTS WITH A SUSTAINED VIROLOGICAL RESPONSE E. Degasperi 1 , M. Fraquelli 2 , E. Grassi 1 , R. D’Ambrosio 1 , A. Aghemo 1 , M. Colombo 1 1 Centro A.M. e A. Migliavacca, First Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy 2 Second Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy
Background: A sustained virological response (SVR) to anti-HCV therapy can result in fibrosis and cirrhosis regression. A recent study demonstrated that the accuracy of transient elastography (TE) in assessing cirrhosis regression after an SVR is low, while the performance of other non-invasive tests is still unclear. Aim: To investigate the accuracy of non-invasive tests for assessing residual cirrhosis in HCV patients after an SVR. Methods: All HCV patients with a pre-treatment histological diagnosis of cirrhosis and available post-SVR liver biopsies had residual liver fibrosis assessed through the following noninvasive methods: APRI, CDS, Fib4, FibroQ, Forns score, Guci Index, King score, Lok Index, PLF. Liver fibrosis staged according to the METAVIR score was the reference standard. The performances of non-invasive tests to diagnose residual cirrhosis were calculated using receiver operating characteristic (ROC) curves analysis. Results: 20 out of 33 patients (61%) included in the study had cirrhosis regression after 61 (48–104) months from an SVR. The overall diagnostic accuracy of all the noninvasive serum panels analyzed was suboptimal as indicated by the AUROC values and the operative characteristics of the tests. None of these tests is useful in identifying patients with residual cirrhosis when using both the cut-off indicated by the literature (bold) and the cut off with the best sensitivity and specificity derived from the ROC curves (Table 1). Table 1 Test
Cut off
Sensitivity
Specificity
LR +
LR-
AUROC
APRI* CDS*
>0.2
84
30
1.2
0.5
0.58
(0.39–0.75)
>5 >3.25 >2.3 >2.6 >5.2 >6.9 >5 >0.26 >0.52 >16.7 >10.1 >0.5 >2.98 >2.6
46 15 31 85 46 23 38 76 38 15 46 30 31 58
75 99 95 25 90 90 55 30 85 99 85 95 95 90
1.8 15 6.1 1.1 4.6 2.3 0.8 1.1 2.5 15 3.1 6.1 6.5 5.8
0.6 0.8 0.7 0.6 0.60 0.8 1.1 0.7 0.7 0.8 0.6 0.73 0.7 0.4
0.60 0.59
(0.41–0.76) (0.41–0.76)
Fib 4 Fibro Q Forns score Guci index King score Lok index PLF *
95% CI
0.61
(0.42–0.78)
0.52
(0.34–0.70)
0.57
(0.39–0.74)
0.59
(0.40–0.75)
0.60 0.75
(0.42–0.77) (0.57–0.89)
All the patients had values lower than the standard cut off.
Conclusions: Most of non-invasive serologic tests are not accurate in assessing fibrosis stage and identifying cirrhotics after an SVR. Histological evaluation through liver biopsy still remains the gold standard in these patients. http://dx.doi.org/10.1016/j.dld.2014.01.038