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Unresectable hepatocellular carcinoma: MR imaging after intraarterial therapy. Part I. Identification and validation of volumetric functional response criteria.

ABSTRACT: To identify and validate the optimal thresholds for volumetric functional MR imaging response criteria to predict overall survival after intraarterial treatment (IAT) in patients with unresectable hepatocellular carcinoma (HCC).Institutional review board approval and waiver of informed consent were obtained. A total of 143 patients who had undergone MR imaging before and 3-4 weeks after the first cycle of IAT were included. MR imaging analysis of one representative HCC index lesion was performed with proprietary software after initial treatment. Subjects were randomly divided into training (n = 114 [79.7%]) and validation (n = 29 [20.3%]) data sets. Uni- and multivariate Cox models were used to determine the best cutoffs, as well as survival differences, between response groups in the validation data set.Optimal cutoffs in the training data set were 23% increase in apparent diffusion coefficient (ADC) and 65% decrease in volumetric enhancement in the portal venous phase (VE). Subsequently, 25% increase in ADC and 65% decrease in VE were used to stratify patients in the validation data set. Comparison of ADC responders (n = 12 [58.6%]) with nonresponders (n = 17 [34.5%]) showed significant differences in survival (25th percentile survival, 11.2 vs 4.9 months, respectively; P = .008), as did VE responders (n = 9 [31.0%]) compared with nonresponders (n = 20 [69.0%]; 25th percentile survival, 11.5 vs 5.1 months, respectively; P = .01). Stratification of patients with a combination of the criteria resulted in significant differences in survival between patients with lesions that fulfilled both criteria (n = 6 [20.7%]; too few cases to determine 25th percentile), one criterion (n = 9 [31.0%]; 25th percentile survival, 6.0 months), and neither criterion (n = 14 [48.3%]; 25th percentile survival, 5.1 months; P = .01). The association between the two criteria and overall survival remained significant in a multivariate analysis that included age, sex, Barcelona Clinic for Liver Cancer stage, and number of follow-up treatments.After IAT for unresectable HCC, patients can be stratified into significantly different survival categories based on responder versus nonresponder status according to MR imaging ADC and VE cutoffs.

SUBMITTER: Bonekamp S

PROVIDER: S-EPMC3721055 | biostudies-other | 2013 Aug

REPOSITORIES: biostudies-other

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Project description:PurposeTo prospectively assess serial changes in contrast material-enhanced and diffusion-weighted (DW) magnetic resonance (MR) imaging values within 1 month after transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC).Materials and methodsInstitutional review board approval was obtained for this prospective HIPAA-compliant study. MR imaging was performed before and within 24 hours after TACE in 24 patients with HCC (21 male, three female; mean age, 59 years and 62 years, respectively). Serial MR imaging was subsequently performed 1, 2, 3, and 4 weeks after therapy. The imaging protocol included fast spin-echo T2-weighted MR imaging, breath-hold DW echo-planar MR imaging, and breath-hold unenhanced and contrast-enhanced T1-weighted three-dimensional fat-suppressed gradient-recalled-echo MR imaging in the arterial and portal venous phases. Tumor size, enhancement, and apparent diffusion coefficient (ADC) values were recorded before and sequentially after treatment. Regression models for the correlated data were used to assess changes in these parameters over time after TACE.ResultsMean tumor size was 7.5 cm and was unchanged up to 4 weeks after therapy. Reduction in tumor enhancement in the arterial phase occurred immediately after TACE, with a consistent reduction occurring 1-3 weeks after therapy (P = .001). Reduction in tumor enhancement in the portal venous phase also occurred immediately after TACE, with a consistent reduction occurring 1-3 weeks after therapy (P = .0003). The increase in tumor ADC value was significant 1-2 weeks after therapy (P = .004), borderline significant 3 weeks after therapy, and insignificant 24 hours and 4 weeks after therapy.ConclusionSignificant reduction in tumor enhancement occurred within 24 hours after TACE and persisted up to 4 weeks after TACE. Lesser changes in the ADC value appeared 1 week after TACE, persisted through 2 weeks after TACE, and became less apparent 3 and 4 weeks after TACE. No change in tumor size was recorded during the follow-up period.

Project description:Immune checkpoint inhibitor therapy has shown promising results in patients with unresectable hepatocellular carcinoma. This study aimed to evaluate the effectiveness and safety of sintilimab, a programmed cell death protein-1 (PD-1) blockade, combined with sorafenib and transhepatic arterial chemotherapy and embolization in this patient population, compared with sintilimab monotherapy and sintilimab-sorafenib duotherapy. This was a 22 months single center retrospective cohort study in China. 80 patients with unresectable hepatocellular carcinoma were included, with diagnosis confirmed by either histologic, cytologic or diagnostic imaging analysis. The patients were divided into three groups based on therapeutic regimen: sintilimab monotherapy (sintilimab group, n = 22), sintilimab-sorafenib duotherapy (duplex group, n = 23), sintilimab-sorafenib and transcatheter arterial chemoembolization combined therapy (triple group, n = 35). The principal evaluation criteria were overall survival and progression free survival in the population, assessed according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1). Secondary evaluation criteria were safety, objective response rate and disease control rate. From March 1st, 2019 to December 31, 2020, 80 patients with unresectable hepatocellular carcinoma were included and divided into three treatment groups (22 received sintilimab monotherapy, 23 received sintilimab-sorafenib duotherapy, and 35 received sintilimab-sorafenib combined with transcatheter arterial chemoembolization). The median overall survival of all patients was 11.0 months (95% CI 7.7-14.3). Median overall survival was 13.0 months (95% CI NE-NE), 9.0 months(95% CI 6.3-11.7)and 3.0 months (95% CI 1.9-4.1, p < 0.0001) in the triple therapy, duplex and sintilimab groups respectively, while the corresponding median progression-free survival were 5.0 months (95% CI 2.9-7.1, p < 0.001), 4.0 months (95% CI 2.8-5.2) and 2.0 months (95% CI 1.7-2.3). Disease control and clinical benefits rates were higher in the triple therapy group (80%, 95% CI 63.1-91.6, p < 0.001; 54.3%, 95% CI 36.6-71.2, p < 0.01) compared to the sintilimab group. Median duration of disease control was 4.0 months (95% CI NE-NE, p < 0.01) in the triple therapy group, longer than that of the duplex group (2.0 months, 95% CI 0.9-3.1) and sintilimab group (2.0 months, 95% CI 0.8-3.2). Grade 3 or 4 treatment-related adverse events occurred in 26.3% of 80 patients with hypertension was the most common event observed (38, 47.5%), however, other severe toxic effects were infrequent. Sintilimab combined with sorafenib and transcatheter arterial chemoembolization might have more beneficial effects on overall and progression-free survival and on the duration of disease control outcomes than both sintilimab monotherapy and sintilimab-sorafenib duotherapy in patients with unresectable hepatocellular carcinoma. This triple therapy model might represent an innovative and effective option for inoperable liver cancer.

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Unresectable hepatocellular carcinoma: MR imaging after intraarterial therapy. Part I. Identification and validation of volumetric functional response criteria.

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