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Liver transplantation (LT) is the primary treatment for patients with early-stage hepatocellular carcinoma (HCC). However, the 5-year survival rate after LT remains low for patients with advanced HCC. Recently, combining programmed cell death protein-1 (PD-1) inhibitors with hepatic arterial infusion chemotherapy (HAIC) has achieved promising outcomes in advanced HCC treatment. However, there is a lack of sufficient clinical data demonstrating its effectiveness as a pre-LT down-staging treatment. The current study presented a case of advanced HCC beyond the Milan criteria who underwent LT and achieved a favorable outcome following PD-1 inhibitor combined with FOLFOX-HAIC therapy. Of note, due to treatment-induced tumor necrosis, precise post-treatment tumor size evaluation became challenging. To address this, circulating tumor DNA (ct-DNA) clearance was used as the LT criterion. After three cycles of Pembrolizumab and FOLFOX-HAIC therapy, the patient's serum ctDNA became undetectable and serum α-fetoprotein levels returned to normal. Magnetic resonance imaging results also revealed a significant reduction in liver tumor size post down-staging treatment. Subsequent to LT, serum ctDNA was monitored every two months, consistently yielding diminished results. There were no clinical signs of recurrence 19 months post-LT. These findings suggest that Pembrolizumab in combination with FOLFOX-HAIC may serve as a potential down-staging strategy prior to LT. In addition, ctDNA clearance may be considered a viable biomarker for LT eligibility.

Background Recently, the conversion therapies of FOLFOX-HAIC for patients with unresectable hepatocellular carcinoma (uHCC) have dramatically increased the tumor responses and conversion rate; thus, the prognosis of uHCC patients was expected to be prolonged. However, the postoperative recurrence of uHCC patients who successfully underwent conversion therapies stayed high. The present study evaluated the efficacy and safety of postoperatively adjuvant therapy in treating uHCC patients who received FOLFOX-HAIC-based conversion therapy. Methods In this real-world retrospective study, uHCC patients who received FOLFOX-HAIC-based conversion therapy were included. The recurrence-free survival (RFS), as primary outcomes, was compared between patients who received adjuvant therapy (AT group) or non-adjuvant therapy (nAT group) using survival analysis and Cox regression. Imbalances in baseline clinical features between the two groups were adjusted through propensity score matching (PSM) and inverse probability of treatment weighting (IPTW). Results Between January 2016 and December 2022, 204 uHCC patients who received FOLFOX-HAIC-based conversion therapy were included and assigned into AT group ( n  = 47) and nAT group ( n  = 157), respectively. The median RFS was significantly longer in the AT group than the nAT group before adjustment [19.2 vs. 10.8 months; hazard ratio (HR), 0.584; 95% CI, 0.383–0.892; P  = 0.028], after PSM and after IPTW. Subsequent subgroup analyses revealed the RFS of adjuvant therapy was best in uHCC patients with younger than 60 years, macrovascular invasion, and positive hepatitis B surface antigen. Conclusion Postoperatively, adjuvant therapy was associated with improved survival outcomes compared with non-adjuvant therapy after FOLFOX-HAIC-based conversion therapy among uHCC patients, especially for patients with macrovascular invasion and positive hepatitis B surface antigen.

Hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen has demonstrated efficacy in patients with unresectable hepatocellular carcinoma (HCC). The combined targeted and immunotherapy has emerged as a first-line treatment for liver cancer. In this study, we investigated the clinical efficacy and safety of FOLFOX-HAIC in combination with targeted immunotherapy in patients with untreated, unresectable HCC. Data were collected from patients with initially unresectable HCC treated at Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, from June 2022 to June 2023. Tumor response and survival outcomes were assessed following the FOLFOX-HAIC combined with targeted immunotherapy, The safety was also evaluated through the incidence of related adverse events. A total of 51 eligible patients were recruited. The objective response rate (ORR) based on mRECIST and RECIST 1.1 criteria were 60.8% and 45.1%, respectively. The surgical conversion rate was 25.5%. The median progression-free survival (PFS) was 15.2 months. The 1-year overall survival rate was 88.2%. Adverse events were observed in 98% patients, with 23.5% experiencing grade 3 or 4 adverse events. The FOLFOX-HAIC combined with targeted immunotherapy regimen is effective in patients with unresectable HCC, demonstrated by a high surgical conversion rate and manageable adverse effects. This regimen represents a potential novel first-line treatment option for HCC.

Purpose: The purpose of this study was to evaluate a cost-effectiveness analysis of hepatic arterial infusion chemotherapy with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX-HAIC) as the first-line treatment for patients with large unresectable hepatocellular carcinoma (HCC) compared with transarterial chemoembolization (TACE). Methods: A Markov model was constructed to simulate the first-line treatment, disease recurrence, and survival of patients with large unresectable HCC. Transition probabilities were based on clinical trial data. The costs and health utilities were derived from the public literature. The outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratios (ICER). One-way and probabilistic sensitivity analyses were performed to examine model uncertainty. We also performed subgroup analyses. Results: The results of the base case analysis found that FOLFOX-HAIC increased overall costs by$9,381 and improved effectiveness by 1.01 QALYs compared with TACE. The one-way sensitivity analysis showed that the hazard ratio of progression-free survival and overall survival for FOLFOX-HAIC relative to TACE had the greatest impact on the ICER. Probabilistic sensitivity analysis found that the probability of FOLFOX-HAIC treatment being cost-effective was 99.54% at the willingness-to-pay threshold of $ 30,552/QALY. Patients in most subgroups favored FOLFOX-HAIC treatment because it had a more than 50% probability of being cost-effective than TACE, except for patients with negative hepatitis B infection. Conclusion: In conclusion, our study found that the FOLFOX-HAIC was a cost-effective option compared to TACE for patients with large unresectable HCC in China.

This study aimed to examine the effectiveness of the best response rate (BRR) as a surrogate for overall survival (OS), using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), in patients with unresectable hepatocellular carcinoma (HCC) undergoing hepatic arterial infusion chemotherapy (HAIC) with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) combined with molecular targeting and immunotherapy. This study enrolled 111 consecutive patients who had complete imaging data. The median age of patients was 58 years (IQR 50.5-65.0). Among the patients, those with Barcelona Clinic Liver Cancer (BCLC) stage A, BCLC stage B, and BCLC stage C comprised 6.4%, 19.1%, and 73.6%, respectively. The optimal threshold of BRR can be determined using restricted cubic splines (RCS) and the rank sum statistics of maximum selection. Survival curves of patients in the high rating and low rating groups were plotted. We then used the change-in-estimate (CIE) method to filter out confounders and the inverse probability of treatment weighting (IPTW) to balance confounders between the two groups to assess the robustness of the results. The median frequency of the combination treatment regimens administered in the overall population was 3 times (IQR 2.0-3.0). The optimal BRR truncation value calculated was -0.2. Based on this value, 77 patients were categorized as the low rating group and 34 as the high rating group. The differences in the OS between the high and low rating groups were statistically significant (7 months [95%CI 6.0-14.0] vs. 30 months [95%CI 30.0-]; p< 0.001). Using the absolute 10% cut-off value, the CIE method was used to screen out the following confounding factors affecting prognosis: successful conversion surgery, baseline tumor size, BCLC stage, serum total bilirubin level, number of interventional treatments, alpha-fetoprotein level, presence of inferior vena cava tumor thrombus, and partial thrombin activation time. The survival curve was then plotted again using IPTW for confounding factors, and it was found that the low rating group continued to have better OS than the high rating group. Finally, the relationship between BRR and baseline factors was analyzed, and inferior vena cava tumor thrombus and baseline tumor size correlated significantly with BRR. BRR can be used as a surrogate endpoint for OS in unresectable HCC patients undergoing FOLFOX-HAIC in combination with molecular targeting and immunotherapy. Thus, by calculating the BRR, the prognosis of HCC patients after combination therapy can be predicted. Inferior vena cava tumor thrombus and baseline tumor size were closely associated with the BRR.