Response Evaluation Criteria In Cancer Research Articles

Efficacy and Safety of Three-dimensional Conformal Radiotherapy for Macroscopic Vascular Invasion of Hepatocellular Carcinoma.

Chemotherapy is insufficient to treat macroscopic vascular invasion (MVI) of hepatocellular carcinoma (HCC). We retrospectively investigated the treatment outcomes of patients who underwent three-dimensional conformal radiotherapy (3D-CRT) for HCC MVI and analyzed prognostic factors by multivariate analysis using a Cox proportional hazard model. Sixty-five patients were studied. MVI sites were the portal vein (n=48 patients), portal and hepatic veins (n=8), and hepatic vein (n=9). The median irradiation dose was 50 Gy. The median survival time (MST) was 7.5 months. Performance status 2 or 3, modified albumin-bilirubin grade 2b or 3, and massive/diffuse type were poor prognostic factors. Nineteen patients (29%) with a treatment effect of 3 or 4 (≥ 50% of tumor necrosis or regression) at the irradiation sites according to the Response Evaluation Criteria in Cancer of the Liver showed longer survival than those with an effect of 1 or 2 (MST 18.7 vs. 5.9 months, p<0.001). No treatment-related death occurred. The hepatic function reserve was preserved in more than 70% of patients. 3D-CRT controlled HCC MVI safely and was suggested to be a good treatment option.

Response Evaluation Criteria in Cancer of the liver version 6 (Response Evaluation Criteria in Cancer of the Liver 2021 revised version).

Response Evaluation Criteria in Solid Tumors (RECIST) is inappropriate to assess the direct effects of treatment on hepatocellular carcinoma (HCC) by locoregional therapies, such as radiofrequency ablation or transarterial chemoembolization. Therefore, establishment of response evaluation criteria solely devoted to HCC is needed in clinical practice, as well as in clinical trials of HCC treatment, such as systemic therapies, which cause necrosis of the tumor. Response Evaluation Criteria in Cancer of the Liver (RECICL) was revised in 2021 by the Liver Cancer Study Group of Japan based on the 2019 version of RECICL, which was commonly used in Japan. The major revised points of the RECICL 2021 is inclusion of RECIST version 1.1 and modified RECIST as response evaluation criteria in systemic therapy for HCC. We hope this new treatment response criteria, RECICL, proposed by the Liver Cancer Study Group of Japan will benefit the HCC treatment response evaluation in the setting of daily clinical practice and clinical trials as well, not only in Japan, but also internationally.

Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma

Introduction: Several clinical trials comparing the efficacy and safety of transarterial chemoembolization (TACE) plus molecular-targeted agents versus TACE alone revealed no clinical benefits in progression-free survival (PFS) or overall survival (OS). Here, we report the final OS analysis from the TACTICS trial, which previously demonstrated significant improvement in PFS with TACE plus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) (NCT01217034). Methods: Patients with unresectable HCC were randomized to a TACE plus sorafenib group (N = 80) or a TACE alone group (N = 76). Patients in the combination treatment group received sorafenib 400 mg once daily for 2–3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable progression. In this trial, TACE-specific PFS was used. TACE-specific PFS is defined as the time from randomization to progressive disease (PD) or death from any cause, and PD was defined as untreatable progression, caused by the inability of a patient to further receive or benefit from TACE for reasons that include intrahepatic tumor progression (25% increase vs. baseline) according to response evaluation criteria in cancer of the liver, the detection of extrahepatic spread, vascular invasion, or transient deterioration of liver function to Child-Pugh C after TACE. Results: At the cut-off date of July 31, 2020, 131 OS events were observed. The median OS was 36.2 months with TACE plus sorafenib and 30.8 months with TACE alone (hazard ratio [HR] = 0.861; 95% confidence interval [CI], 0.607–1.223; p = 0.40, ΔOS, 5.4 months). The updated PFS was 22.8 months with TACE plus sorafenib and 13.5 months with TACE alone (HR = 0.661; 95% CI, 0.466–0.938; p = 0.02). Post-trial treatments with active procedures/agents were received by 47 (58.8%) patients in the TACE plus sorafenib group and 58 (76.3%) in the TACE alone group (p = 0.01). In post hoc analysis, PFS and OS benefit were shown in HCC patients with tumor burden beyond up-to-7 criteria. Conclusions: In TACTICS trial, TACE plus sorafenib did not show significant OS benefit over TACE alone; however, clinical meaningful OS prolongation and significantly improved PFS was observed. Thus, the TACE plus sorafenib can be considered a choice of treatment in intermediate-stage HCC, especially in patients with high tumor burden. Trial Registration: NCT01217034.

Response Evaluation Criteria in Cancer of the Liver (RECICL 2021 revised version)

Response Evaluation Criteria in Cancer of the Liver (RECICL 2021 revised version)

Local Efficacy and Safety of Transarterial Chemoembolization for Hepatocellular Carcinoma: Epirubicin-Loaded DC Beads vs. Epirubicin-Lipiodol Emulsion with Gelatin Sponge (cTACE).

Purpose: To compare the efficacy and safety between epirubicin-loaded DC Beads (DCB-TACE) and conventional TACE (cTACE) used in transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). Materials and Methods: This retrospective study enrolled 64 patients (mean age, 73.3 years; 44 men, 20 women) who underwent initial DCB-TACE between 2014 and 2015, and 66 patients (mean age, 71.3 years; 38 men, 28 women) who underwent initial cTACE between 2011 and 2013 as historical controls. Treatment effects on the target lesions at 3 months after TACE, the period until re-treatment of the target lesion, and adverse events after TACE were compared between the groups. Univariate and multivariate analyses were also performed to estimate the factors influencing the treatment effects. Results: Based on the Response Evaluation Criteria in Cancer of the Liver version 2015, treatment response of the target lesions equivalent to a complete response and termed as TE4, was 51.0% (53/104) in the DCB-TACE group and 74.4% (64/86) in the cTACE group (p<0.001). Multivariate analysis revealed that the TACE procedure, Child-Pugh score, serum aspartate aminotransferase (AST) level, alpha fetoprotein level, and tumor size were independent significant predictors of TE4. The frequencies of elevated serum AST and alanine transaminase levels after TACE were significantly lower in patients in the DCB-TACE group (p<0.001 each). No significant difference in biliary/liver damage was evident between the groups. Conclusion: The local efficacy of cTACE was higher than that of DCB-TACE. Adverse events were milder after DCB-TACE than after cTACE.

Response Evaluation Criteria in Cancer of the Liver version5 (RECICL 2019 revised version).

Response Evaluation Criteria in Solid Tumors (RECIST) is inappropriate to assess the direct effects of treatment on hepatocellular carcinoma (HCC) by locoregional therapies, such as radiofrequency ablation and transarterial chemoembolization. Therefore, establishment of response evaluation criteria solely devoted to HCC is needed in clinical practice, as well as in clinical trials of HCC treatment, such as systemic therapies, which cause necrosis of the tumor. Response Evaluation Criteria in Cancer of the Liver (RECICL) was revised in 2019 by the Liver Cancer Study Group of Japan based on the 2015 version of RECICL, which was commonly used in Japan. The major revised points of the RECICL 2019 are as follows: (i) CEA and CA19-9 have been newly added as tumor markers that should be recorded for use as criteria in the response evaluation for intrahepatic cholangiocarcinoma; (ii) the criteria now state that the details of molecular targeted therapy should be specified; and (iii) specific methods for overall evaluation are now described. Also, as an assessment of overall TE4 requires that TE4 is achieved in all nodules (even non-target lesions), the same calculation methods described above are used. We hope this new treatment response criteria, RECICL, proposed by the Liver Cancer Study Group of Japan will benefit the HCC treatment response evaluation in the setting of daily clinical practice and clinical trials as well, not only in Japan, but also internationally.

Preoperative MRI features and clinical laboratory indicators for predicting the early therapeutic response of hepatocellular carcinoma to transcatheter arterial chemoembolization combined with High-intensity focused ultrasound treatment.

To evaluate the value of preoperative MRI features and laboratory indicators in predicting the early response of hepatocellular carcinoma (HCC) to transcatheter arterial chemoembolization (TACE) combined with high-intensity focused ultrasound (HIFU) treatment and to establish a preoperative prediction model. A total of 188 patients with 223 tumors who underwent TACE/HIFU treatment from January 2011 to June 2017 were included. Tumors were divided into three groups (< 2 cm, 2 - 5 cm,> 5 cm) and classified as non-complete response (NCR) and complete response (CR) cohorts according to the Response Evaluation Criteria in Cancer of the Liver (RECICL) 2015 revised version. Univariate analysis and multivariate logistic regression analysis were used to determine independent predictors, and receiver operating characteristic (ROC) curve analysis was performed to assess the diagnostic power of each predictor. The prediction model was derived on the β coefficient of the multivariate regression analysis of the predictors. Irregular margins in the 2 - 5 cm group were closely related to early NCR. Irregular margins, arterial peritumoral enhancement and abnormal alpha-fetoprotein (AFP) were independent predictors of early NCR in the > 5 cm group. The prediction model of this group suggests that irregular margins combined with arterial peritumoral enhancement and abnormal AFP combined with irregular margins and arterial peritumoral enhancement predict an increased risk of early NCR. Irregular margins of 2 - 5 cm tumors and irregular margins, arterial peritumoral enhancement, and abnormal AFP of tumors > 5 cm can be applied to predict the early response of HCC to TACE/HIFU treatment. TACE combined with HIFU treatment may be able to significantly improve survival in patients with advanced HCC. Conventional MRI features and laboratory indicators are readily available without complex post-processing. It is feasible to predict the response of HCC after TACE/HIFU treatment based on preoperative conventional MRI features and laboratory indicators, the combination of multiple features predicts high-risk of non-complete response.

Response Evaluation Criteria in Cancer of the Liver (RECICL 2019 revised version)

Response Evaluation Criteria in Cancer of the Liver (RECICL 2019 revised version)

Value of texture analysis based on enhanced MRI for predicting an early therapeutic response to transcatheter arterial chemoembolisation combined with high-intensity focused ultrasound treatment in hepatocellular carcinoma

To evaluate the potential value of texture analysis (TA) based on contrast-enhanced magnetic resonance imaging (MRI) for predicting an early response of patients with hepatocellular carcinoma (HCC) who were treated with transcatheter arterial chemoembolisation (TACE) combined with high-intensity focused ultrasound (HIFU). Patients with HCC (n=89) who underwent contrast-enhanced MRI at 1.5 T 1 week before and 1 week, 1 month, and 3 months after TACE/HIFU were included in this retrospective study. Early responses were evaluated by two radiologists according to the Response Evaluation Criteria in Cancer of the Liver (RECICL). An independent Student's t-test and the Mann-Whitney U-test were used to compare the TA parameters between the complete response (CR) group and the non-complete response (NCR) group. Logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the predictive value of the NCR lesions. Among the 89 patients, 58 showed CR and 31 showed NCR. Before TACE/HIFU, the CR group showed higher uniformity and energy but lower entropy than the NCR group (p<0.05). After TACE/HIFU, the CR group showed higher uniformity and energy but lower entropy and skewness than the NCR group (p<0.05). The logistic regression and ROC curve analyses showed that the entropy before TACE/HIFU and the skewness and entropy 1 week after TACE/HIFU were predictors of an early response. TA parameters based on contrast-enhanced MRI images 1 week before and after TACE/HIFU may act as imaging biomarkers to predict an early response of patients with HCC.

Inter-operator variability and source of errors in tumour response assessment for hepatocellular carcinoma treated with sorafenib.

To assess the inter-operator concordance and the potential sources of discordance in defining response to sorafenib in hepatocellular carcinoma (HCC). All patients who received sorafenib between September 2008 and February 2015 were scrutinised for this retrospective study. Images were evaluated separately by three radiologists with different expertise in liver imaging (operator 1, >10 years; operator 2, 5 years; operator 3, no specific training in liver imaging), according to: response evaluation radiological criteria in solid tumours (RECIST) 1.1, modified RECIST (mRECIST) and response evaluation criteria in cancer of the liver (RECICL). The overall response concordance between the more expert operators was good, irrespective of the criteria (RECIST 1.1, ĸ = 0.840; mRECIST, ĸ = 0.871; RECICL, ĸ = 0.819). Concordance between the less expert operator and the other colleagues was lower. The most evident discordance was in target lesion response assessment, with expert operators disagreeing mostly on lesion selection and less expert operators on lesion measurement. As a clinical correlate, overall survival was more tightly related with "progressive disease" as assessed by the expert compared to the same assessment performed by operator 3. Decision on whether a patient is a responder or progressor under sorafenib may vary among different operators, especially in case of a non-specifically trained radiologist. Regardless of the adopted criteria, patients should be evaluated by experienced radiologists to minimise variability in this critical instance. • Inter-operator variability in the assessment of response to sorafenib is poorly known. • The concordance between operators with expertise in liver imaging was good. • Target lesions selection was the main source of discordance between expert operators. • Concordance with non-specifically trained operator was lower, independently from the response criteria. • The non-specifically trained operator was mainly discordant in measurements of target lesions.

Predictors of therapeutic effect of transarterial chemoembolisation using drug-eluting beads for hepatocellular carcinoma

To identify predictors of a therapeutic effect after transarterial chemoembolisation using drug-eluting beads (DEB-TACE) for hepatocellular carcinoma (HCC). Between January 2015 and July 2015, tumour variables and angiographic data were collected for 25 patients (49 target lesions) after they had undergone the DEB-TACE procedure for HCC. The therapeutic effect was evaluated according to the Response Evaluation Criteria in Cancer of the Liver at follow-up dynamic computed tomography (CT) performed within 1-4 months after the procedure. A p<0.05 was considered significant. On a target lesion basis, the objective response (TE3/4) rate was 63.3% (31 of 49). On univariate analysis, larger size (≥2cm) was a predictor of an objective response (p=0.029). The tumour location of the medial (segment 4) or caudate (segment 1) lobe also indicated a poor therapeutic effect (TE1/2), but not at the level of significance (p=0.051). Multivariate analysis identified tumour size (odds ratio, 8.60; 95% confidence interval, 1.87-62.8) and tumour location (odds ratio, 12.2; 95% confidence interval, 2.12-129.8) as significant factors associated with a therapeutic effect. On a patient basis, 10 of 25 (40%) patients showed complete response/partial response. There were no significant differences between complete response/partial response and stable disease/progressive disease regarding age, gender, tumour markers, history of previous treatment, Child-Pugh class, T-stage, or Barcelona Clinic Liver Cancer Staging. A short-term therapeutic effect was associated with tumour size and location on a target lesion basis.

Usefulness and limitations of balloon-occluded transcatheter arterial chemoembolization using miriplatin for patients with four or fewer hepatocellular carcinoma nodules.

The aim of this study is to clarify the usefulness and limitations of balloon-occluded transcatheter arterial chemoembolization (B-TACE) using miriplatin for patients with four or fewer hepatocellular carcinoma (HCC) nodules. We studied 47 nodules in 30 consecutive patients who received miriplatin by B-TACE to treat HCC with four or fewer nodules per patient. The treatment effect was evaluated using the Response Evaluation Criteria in Cancer of the Liver. Nodules were divided according to the presence or absence of portal vein visualization during B-TACE. In the presence group, dynamic computed tomography at 3months post-therapy showed Response Evaluation Criteria in Cancer of the Liver treatment effect (TE) 4 in 88% (14/16), TE3 in 0% (0/16), TE2 in 0% (0/16), TE1 in 12% (2/16), and objective response in 88% of nodules. In the absence group, the results were TE4 in 35% (11/31), TE3 in 13% (4/31), TE2 in 26% (8/31), TE1 in 26% (8/31), and objective response decreased to 48% of nodules. In addition to typical hypervascular nodules, we treated three nodules with irregular ring enhancement that predicted poorly differentiated HCC and four nodules that included a hypoenhancement area that predicted well to moderately differentiated HCC. All irregular ring enhancement nodules achieved TE4. Other nodules that were predicted to be well to moderately differentiated HCC did not have portal vein visualization during B-TACE and could not achieve TE4. Balloon-occluded transcatheter arterial chemoembolization is a useful technique for treatment of classical hypervascular HCC, and portal vein visualization during the B-TACE procedure may provide more favorable local control.

Transarterial embolization of hypervascular tumors using trisacryl gelatin microspheres (Embosphere): a prospective multicenter clinical trial in Japan.

To evaluate the feasibility and safety of transarterial embolization (TAE) using trisacryl gelatin microspheres (TGMs) for hypervascular tumors. This was a prospective multicenter clinical trial involving five institutions. TAE using TGMs was performed for hypervascular tumors in various locations. The primary endpoint was the technical success. The secondary endpoints included catheter accessibility, preservation of the feeding arteries, local tumor response based on the Response Evaluation Criteria in Cancer of the Liver (RECICL) and adverse events related to TAE based on the Common Terminology Criteria for Adverse Events, version 4.0. Twenty-three patients with liver tumors (n=9), uterine fibroids (n=3) and other tumors (n=11) were enrolled. The technical success rate was 95.7% (22 of 23 patients). Catheter accessibility and preservation of the feeding arteries were obtained in all 55 target vessels (100%). Local tumor response rates were 46.7 and 55.8% at 4 and 12weeks, respectively. Eighteen (78.3%) patients developed 53 symptomatic events including grade ≧3 events: hypertension 21.7%, pain 8.7%, vomiting 4.3% and anorexia 4.3%, all related to postembolization syndromes. TAE using TGMs was technically feasible and safe for devascularization of hypervascular tumors.

Hemodynamic changes under balloon occlusion of hepatic artery: predictor of the short-term therapeutic effect of balloon-occluded transcatheter arterial chemolipiodolization using miriplatin for hepatocellular carcinoma.

To clarify the hemodynamic changes under balloon occlusion of the hepatic artery and to identify predictors of the short-term therapeutic effect (TE) after balloon-occluded transcatheter arterial chemoembolization using miriplatin (B-TACE) for hepatocellular carcinoma (HCC). Tumor variables and angiographic data were collected for 35 nodules (29 patients) with a B-TACE for HCC. Lesions were classified into three groups based on the balloon-occluded CT hepatic arteriography (BO-CTHA) results: Group A, presence of corona enhancement; Group B, absence of corona enhancement; Group C, decreased perfusion or perfusion defect compared to standard CTHA. Objective response was defined as TE3/4, and poor TE as TE1/2, evaluated by response evaluation criteria in cancer of the liver at 1–4 months after the procedure. Univariate analysis revealed that proximal level of balloon occlusion, intratumoral lower CT values immediately after treatment and BO-CTHA findings were significantly correlated with poor TE (p = 0.034, 0.037, and 0.003, respectively). Multivariate logistic analysis identified the Group C as a significant factor associated with the worse short term TE (odds ratio 8.34; 95 % confidence interval 1.49–68.8). Partial or complete perfusion defect on BO-CTHA was an independent factor associated with poor therapeutic effect.

Balloon-Occluded Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: A Single-Center Experience

Objective: To investigate whether balloon-occluded transcatheter arterial chemoembolization (b-TACE) can produce a more dense accumulation of iodized oil in various stages of hepatocellular carcinoma (HCC), from single to uncountable, to overcome inferior local control. Materials and Methods: We studied 27 patients with HCC, including single to uncountable multiple lesions, who underwent b-TACE between August 2013 and April 2015. Dynamic CT was performed at baseline and 1-3 months after b-TACE. The treatment effect (TE) after b-TACE was evaluated using the Response Evaluation Criteria in Cancer of the Liver (RECICL) proposed by the Liver Cancer Study Group of Japan. Results: In the countable HCC group, contrast-enhanced CT demonstrated RECICL TE4 in 43.8% (14/32), TE3 in 12.5% (4/32), TE2 in 37.5% (12/32), and TE1 in 6.3% (2/32) of patients. For the TACE-naïve cohort, the objective response rate was 52.9%. The objective response rate was 60% for the previously TACE-treated cohort. In the uncountable multiple HCC group, the objective response rate was 0% (0/10), with progressive disease in 90% (9/10) of patients. Conclusion: Our observations suggested that b-TACE did not reduce the efficacy of retreatment for HCC with an insufficient outcome from conventional TACE, but it could not improve the efficacy of treatment for uncountable multiple HCCs.

Real-Life Clinical Practice with Sorafenib in Advanced Hepatocellular Carcinoma: A Single-Center Experience Second Analysis

Objectives: Sorafenib has become a standard therapy for advanced hepatocellular carcinoma following the demonstration of significant increase in progression-free survival as well as overall survival (OS) in the 2-phase III trials. We examined efficacy and adverse events (AEs) in patients treated with sorafenib over a 6-year period since approval in Japan. Methods: Two hundred and forty-one patients treated with sorafenib at the Kinki University Hospital were retrospectively analyzed clinically for the factors related to survival periods, tumor response evaluated by the Response Evaluation Criteria In Cancer of the Liver (RECICL) and AEs. Results: OS was 14.3 months. According to the RECICL, the objective response and disease control rates were 18.6% (43 of 241) and 61.1% (137 of 241), respectively. AEs were seen in 77.3% (187 of 241), with Grade 3 or higher in 23.6% (57 of 241). The most frequent AE was hand-foot skin reaction in 109 patients (45.0%), and 28 patients (11.8%) showed Grade 3 or higher. Significant factors contributing to the OS were treatment duration (p = 0.0204), up-to-7 criteria (p = 0.0400), increase of Child-Pugh score (p = 0.0008) and tumor response determined by the RECICL (p = 0.0007). Conclusion: Based on the analysis, using many cases at a single center, we concluded that continuation of treatment with sorafenib for ≥90 days without decrease of liver function was critical if tumor response was determined as stable disease or higher.

Response Evaluation Criteria in Cancer of the Liver (RECICL) (2015 Revised version).

The Response Evaluation Criteria in Solid Tumors (RECIST) is inappropriate to assess the direct effects of treatment on hepatocellular carcinoma (HCC) by locoregional therapies such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE). Therefore, establishment of response evaluation criteria solely devoted to HCC is needed urgently in clinical practice as well as in clinical trials of HCC treatment, such as molecular-targeted therapies, which cause necrosis of the tumor. The Response Evaluation Criteria in Cancer of the Liver (RECICL) was revised in 2015 by the Liver Cancer Study Group of Japan based on the 2009 version of RECICL, which was commonly used in Japan. Major revised points of the RECICL 2015 is to define the target lesions of two lesions per organ or three lesions per liver, up to a maximum of five lesions. The second revised point is that setting the timing at which the overall treatment response has been changed. The third point is that the definition of treatment effect 1 has been changed to more than 50% tumor enlargement, excluding the area of necrosis after treatment. Overall evaluation of treatment response has been amended to make it possible to evaluate the overall response including extrahepatic lesions by systemic therapy, which is similar to RECIST or modified RECIST. We hope this new treatment response criteria, RECICL, proposed by the Liver Cancer Study Group of Japan will benefit HCC treatment response evaluation in the setting of daily clinical practice and clinical trials, not only in Japan, but also internationally.

肝癌治療効果判定基準（2015年改訂版）

肝癌治療効果判定基準（2015年改訂版）

Transcatheter arterial infusion for advanced hepatocellular carcinoma: Who are candidates?

To elucidate anticancer effects of transcatheter arterial infusion chemotherapy (TAI) in patients with hepatocellular carcinoma (HCC). Data from a total of 95 patients with HCC who received TAI were analyzed retrospectively. The efficacy of TAI was evaluated according to the Response Evaluation Criteria in Cancer of the Liver. Overall survival was calculated from the date of initial treatment to the date of death or last follow-up. Survival curves were calculated by the Kaplan-Meier method, and differences in survival were evaluated by the log rank test. Clinical variables that were identified as statistically different by a univariate analysis were included into the Cox proportional hazard regression model for multivariate analysis. A prognostic index based on the regression coefficients derived from variables identified by the multivariate analysis was constructed. Stratification of the patients was conducted using this prognostic index. The patient group was comprised of 76 men and 19 women with an average age of 68 years (range: 37-82 years). Six patients (6.3%) showed complete response and 18 patients (18.9%) showed partial response, for an overall response rate of 25.2%. The median overall survival was 27.6 mo, and the proportions of survivors at 1, 2, and 5 years were 67.4%, 54.0%, and 17.4%, respectively. Multivariate analysis demonstrated that no prior transcatheter arterial chemoembolization, lactate dehydrogenase < 230 IU/L, and performance status of 0 were the independent favorable prognostic factors. The development of a 0-3-point prognostic score index was based on the sum of these three prognostic factors. Subsequently, the patients were categorized into three groups: those with a good (prognostic index = 0-1; n = 54), intermediate (prognostic index = 2; n = 26), or poor (prognostic index = 3; n = 15) prognosis. The median survival times in these three groups were 41.0, 21.2, and 6.8 mo, respectively (P < 0.01). Our simple prognostic index may be helpful for management of patients in determining treatment strategies for advanced HCC in the era of molecularly targeted therapy.

Comparison of systems for assessment of post-therapeutic response to sorafenib for hepatocellular carcinoma

BackgroundTo test the hypothesis that use of the response evaluation criteria in cancer of the liver (RECICL), an improved evaluation system designed to address the limitations of the response evaluation criteria in solid tumors 1.1 (RECIST1.1) and modified RECIST (mRECIST), provides for more accurate evaluation of response of patients with hepatocellular carcinoma (HCC) to treatment with sorafenib, a molecularly targeted agent, as assessed by overall survival (OS).MethodsThe therapeutic response of 156 patients with advanced HCC who had been treated with sorafenib therapy for more than 1 month was evaluated using the RECIST1.1, mRECIST, and RECICL. After categorization as showing progressive disease (PD), stable disease (SD), or objective response, the association between OS and categorization was examined using the Kaplan–Meier method to develop survival curves. The 141 cases categorized as PD or SD by the RECIST1.1, but objective response by the mRECIST and RECICL, were further analyzed for determination of the association between OS and categorization.ResultsOnly categorization using the RECICL was found to be significantly correlated with OS (p = 0.0033). Among the patients categorized as SD or PD by the RECIST1.1, reclassification by the RECICL but not the mRECIST was found to be significantly associated with OS and allowed for precise prediction of prognosis (p = 0.0066).ConclusionsOnly the use of the RECICL allowed for identification of a subgroup of HCC patients treated with sorafenib with improved prognosis. The RECICL should, therefore, be considered a superior system for assessment of therapeutic response.Electronic supplementary materialThe online version of this article (doi:10.1007/s00535-014-0936-0) contains supplementary material, which is available to authorized users.