bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anticoagulation for portal vein thrombosis in patients with hepatocellular carcinoma: A retrospective observational study.
Authors: Antonios Kais , Antonios Bana , Al-Banaa Kadhim , Chisti Mohammad Muhsin 
Published: June 2023

e16212 Background: Portal vein thrombosis (PVT) occurs in 10-40% of patients with hepatocellular carcinoma (HCC). Advanced imaging modalities, such as MRI, can differentiate between bland PVT and tumor thrombus, and help determine the need for anticoagulation (AC). Our study aims to assess the use of AC in patients with HCC and concomitant PVT. Methods: We conducted a retrospective observational study at eight hospitals in a community healthcare system in southeast Michigan. Patients with a combined diagnosis of HCC and PVT were identified between August 2016 and September 2022. Demographics, clinical characteristics, use of AC, type of thrombus, and median survival were collected through chart review. Results: A total of 122 patients were diagnosed with HCC and PVT (17 patients were lost to follow-up). The median age at diagnosis was 72.7 years and 77.1% of patients were male. Majority (66.6%) of patients were white. Underlying cirrhosis was present in 85.7% of patients, of which 41% was due to HCV infection. Around half of the patients had a Child-Pugh Class-B at diagnosis. AC was started in 46% of patients, with apixaban being the most commonly used agent (56%). Imaging results in the AC group confirmed that 52% of patients had a tumor thrombus. Of all the patients started on AC, 25% had bleeding complications. Overall, death occurred in 52.1% of patients in the AC group compared to 57.9% of patients who did not receive AC. Median survival was 6 months in both groups (p=0.7). Using cox-proportional hazards model, there was no difference observed in overall survival between patients who received AC and patients who did not (HR 0.91, 95% CI 0.54-1.53, p=0.72). Conclusions: In this retrospective review of patients with HCC and PVT, no difference in survival was observed between patients who received AC and patients who did not receive AC. Further randomized prospective data are needed to guide management in this high-risk patient group. [Table: see text]
The efficacy and safety of donafenib-containing regimens as postoperative adjuvant therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study.
Authors: Rao Jianhua , Zhu Xinhua , Zhang Hongwei , Wei Xin , Xu Yonghua , Zhang Long , Zhang Feng , Li Xiangcheng , Cheng Feng 
Published: June 2023

e16213 Background: Hepatectomy is a key treatment for long-term survival in patients (pts) with HCC, but a high recurrence rate seriously affects the prognosis. Currently, there is no standard treatment for adjuvant therapy, transarterial chemoembolization (TACE), anti-angiogenic therapy, immune checkpoint inhibitor (ICI) therapy, or combination strategies being evaluated. Donafenib as first-line systemic therapy is recommended in advanced HCC, but this as adjuvant therapy is still explored. This study evaluated the efficacy and safety of donafenib-containing regimens as postoperative adjuvant therapies in HCC. Methods: We retrospectively reviewed the data of pts who had received donafenib monotherapy (D) or a combined regimen (D+TACE, D+ICI, or D+TACE+ICI) as adjuvant therapy in 5 Chinese centers from June 2021 to December 2022. Recurrence was assessed using imaging. A high-risk (HR) subpopulation was defined as pts with any of the following conditions: [i] single lesion >5 cm or multiple lesions of any size; [ii] lesion(s) complicated by tumor thrombus (TT); and [iii] microvascular invasion (MVI) grade ≥1. We analyzed the median relapse-free survival (mRFS) and one-year cumulative recurrence-free survival rate (1y-RFS) of the overall population and HR subpopulation, and safety (CTCAE5.0) of the overall population. Results: This study included 102 pts. At the data cut-off, mRFS had not yet been achieved, with a 1y-RFS rate of 78.2%; 12 pts (11.8%) experienced recurrence. In the HR subpopulation (N=80), the 1y-RFS rate was 79.4%, based on different treatment regimens, the 1y-RFS rates of the D (n=20), D+TACE (n=26), D+ICI (n=23), and D+TACE+ICI (n=11) groups were 87.5%, 87.7%, 72.4%, and 74.1%, respectively, and mRFS had not yet been reached; based on different clinical stages, the 1y-RFS rates of pts with China liver cancer staging stage Ib (n=35) and IIa (n=15) were 93.3% and 71.6%, respectively, with stage Ⅰa (n=12) and Ⅱb (n=7) were not reached, mRFS with IIIa (n=11) was 8.9 months (95% CI: 2.9–15.0 months). Among the overall population, 68 pts (66.7%) had treatment-related adverse events (TRAE) of any grade, and the incidence of grade 3 TRAE was 8.8% (9/102). None of the pts experienced grade 4 or 5 TRAE. Conclusions: These results preliminarily showed that donafenib-containing regimens as postoperative adjuvant therapies were safe and effective for HCC. [Table: see text]
Real world impact of hepatocellular carcinoma stage and hepatic function on health-related quality of life.
Authors: Gupta Amol , Zorzi Jane , Ho Won Jin , Baretti Marina , Azad Nilofer Saba , Griffith Paige , Dao Doan , Kim Amy K. , Philosophe Benjamin , Georgiades Christos , Kamel Ihab R. , Burkhart Richard , Liddell Robert , Hong Kelvin , Shubert Christopher , Lafaro Kelly , Meyer Jeffrey , Anders Robert A. , Burns William , Yarchoan Mark 
Published: June 2023

e16215 Background: Health-Related Quality of Life (HRQoL) is an important prognostic indicator and clinical endpoint for patients with hepatocellular carcinoma (HCC). The relationship between cancer stage, liver function, performance status, and HRQoL in HCC in a real-world clinical setting is not well defined. Methods: A retrospective chart review was undertaken of consecutive patients with HCC treated at our institution's liver multidisciplinary clinic between February 2020 and August 2022. We examined the relationship between Barcelona Clinic Liver Cancer (BCLC) stage, Child Pugh (CP) score, and Eastern Cooperative Oncology Group (ECOG) performance status on HRQoL at diagnosis. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Results: Fifty-one patients met our inclusion criteria. The median age was 69 and the mean FACT-Hep score was 130.3 ± 20.3. FACT-Hep total and subscales showed no significant association with BCLC stages A, B, and C (p =0.224), except in the Emotional Well Being (EWB) subscale (p =0.001). There was no impact of ECOG performance status on the FACT-Hep scores, except for the Functional Well Being (FWB) subscale (p=0.006). Patients with a CP B had significantly more impairment in FACT-Hep than patients with CP A, including FACT-Hep total score (118.5 ±27.3 versus 134.3 ±23.8; p =0.021) and subscales including the Physical Well Being (p =0.018), FWB (p =0.030), Hepatobiliary Cancer Subscale (p <0.001), and FACT-Hep Trial Outcome Index score (p =0.003). Conclusions: Cancer stage poorly correlates with HRQoL at diagnosis in HCC patients. Impaired liver function reduces overall quality of life in HCC patients. Further large-scale prospective studies should be undertaken which incorporate validated HRQoL tools in the routine assessment of HCC patients. [Table: see text]
A retrospective study exploring the safety and efficacy of hepatic arterial infusion chemotherapy and sequential transarterial embolization combined with lenvatinib and tislelizumab in unresectable hepatocellular carcinoma.
Authors: Zhong Jian-Hong , Chen Zu-Shun , Qi Lu-Nan , Zhang Zhi-Ming , Xiang Bang-De , Ma Liang 
Published: June 2023

e16219 Background: Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) and lenvatinib with or without immune checkpoint inhibitors (ICIs) are first-line treatment in unresectable hepatocellular carcinoma (HCC). However, the objective response rate (ORR) under HAIC plus lenvatinib and ICIs is not satisfactory. Hereby, we retrospectively explore the efficacy and safety of the combination therapy of HAIC sequential transarterial embolization (TAE) combined with lenvatinib and tislelizumab as a first-line treatment in patients with unresectable HCC. Methods: A retrospective analysis of related clinical data of 35 unresectable HCC patients who received HAIC-TAE combined with lenvatinib and tislelizumab were performed. All patients received at least once HAIC sequential TAE combined with lenvatinib and tislelizumab. The primary end-point was the progression-free survival (PFS) rate per mRECIST at six months. The secondary endpoints included safety, objective response rate (ORR), overall survival (OS), surgical conversion rate and disease control rate. Results: Thirty-five patients (65.7% with BCLC C stage while 22.9% with BCLC B stage disease) were enrolled. The primary end-point of PFS rate was 77.1% at six months. However, the median overall survival was not reached at February 10, 2023. The ORR per RECIST 1.1 was 36.4%, and per mRECIST was 63.6% after twice HAIC sequential TAE. Progressive disease was found in 1 patient in each course of HAIC sequential TAE. Eight patients (22.9%) with 12 tumors received curative hepatic resection. Among these eight patients, two patients (25%) and five tumors (41.7%) were with pathological complete response. Six patients (75%) and ten tumors (83.3%) were with tumor necrosis more than 90%. The rate of tumor necrosis more than 50% was 100%. Four patients with partial response received radiotherapy (n=3) or radiofrequency ablation (n=1). The most common adverse events were elevation of alanine aminotransferase, fever and abdominal pain, and no treatment-related death was reported. Conclusions: FOLFOX-HAIC sequential TAE combined with lenvatinib and tislelizumab showed safe and encouraging antitumor activity for unresectable HCC. Based on the data from this study, a prospective, single-arm Phase II trial is planned. Clinical trial information: NCT05532319 .
Sintilimab combined with bevacizumab biosimilar as a conversion therapy in potentially resectable intermediate-stage hepatocellular carcinoma (HCC): Updated results of a phase II trial.
Authors: Sun Huichuan , Zhu Xiaodong , Gao Qiang , Qiu Shuang-Jian , Shi Ying-Hong , Wang Xiao-Ying , Huang Xiao-Wu , Yang Xin-Rong , Ji Yuan , Pang Yanrui , He Yi-Feng , Xu Yong-Feng , Liu Jie , Sun Mingquan , Li Mei-Ling , Zhu Jin-Jin , Shen Ying-Hao , Huang Cheng , Zhou Jian , Fan Jia 
Published: June 2023

e16220 Background: The combination of Sintilimab (a PD-1 antibody) and bevacizumab (bev) biosimilar improved progression-free survival and overall survival in unresectable or advanced HCC as compared with sorafenib in ORIENT-32 study and was approved as first-line treatment for unresectable HCC in China. We assessed the efficacy and safety of the combination therapy as conversion therapy for potentially resectable intermediate-stage HCC. Methods: Treatment-naïve patients (pts) with potentially resectable intermediate stage (BCLC stage B) HCC were enrolled in this phase II trial (NCT04843943). Eligible pts received sintilimab (200 mg, IV, D1) and bev (15 mg/kg, IV, D1) per 3 weeks. Tumor response and resectability were assessed every 6 weeks per RECIST v1.1. Pts with evaluations of partial response (PR) or at least two consecutive stable disease (SD) and eligible for R0 resection were referred for hepatectomy, then continued with sintilimab/bev for at most 12 months. Primary endpoints were event-free survival (EFS) (time from study enrollment to tumor progression, disease recurrence after surgery, or death from any cause) and treatment safety. Secondary endpoints included R0 resection rate, pathologic response, objective response rate (ORR), and disease control rate (DCR). Results: At data cutoff on Feb 7, 2023, 30 pts with BCLC-B stage HCC were enrolled. Of them, 25 pts (83.3%) were up-to-7 criteria out. The median follow-up time was 15.3 months (interquartile range [IQR] 13.8-17.6). ORR and DCR were 26.7% and 90.0% (8 PR and 19 SD). 17 pts (56.7%) met the pre-designated criteria for hepatectomy and received liver resection, including 7 pts were evaluated as PR and 10 as SD before surgery. The median time from initiation of sintilimab/bev to liver resection was 4.3 months (IQR 2.3-5.6). No postoperative mortality was observed. 2 pts had a pathological complete response. Median EFS was 13.8 months (95%CI, 10.3-17.3), and the 6-month and 12-month EFS rates were 76% and 60%, respectively. 3 pts died, and OS data was not mature. Most treatment-related AEs (TRAE) were grade 1-2, and grade 3/4 TRAEs occurred in 7 pts (23.3%). 9 serious adverse events occurred, and 3 of them were treatment associated. Conclusions: For pts with potentially resectable intermediate-stage HCC, sintilimab/bev in combination with liver resection was safe and may improve long-term survival. Clinical trial information: NCT04843943 .
Updated results from ALTER-H004 trial: Anlotinib combined with TACE as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after surgery—A single arm, multi-center, phase II clinical trial.
Authors: Wu Zheng , Wang Zheng , Zhang Lei , Song Xiaojing 
Published: June 2023

e16222 Background: Hepatectomy is deemed as a curative treatment for patients (pts) with hepatocellular carcinoma (HCC). Unfortunately, high recurrent risk after curative resection compromised the long-term survival of HCC significantly. Transarterial chemoembolization (TACE) as adjuvant therapy was proved to improve therapeutic outcomes for pts with high recurrent risk after hepatectomy. However, the survival benefit of TACE remained unsatisfactory. ALTER-H004 trial was designed to identify the efficacy and safety of anlotinib as maintenance adjuvant treatment following TACE in pts with HCC. The preliminary results of ALTER-H004 had been reported at 2022 ASCO (e16120). Here we reported the results at the data cutoff of January 15, 2023. Methods: Pts with one of the following high risk factors after hepatectomy were eligible: ≥5cm and <10cm of tumor diameter, tumor number ≥3, tumor microvascular invasion M1 or M2, portal vein tumor thrombus (Cheng's classification I/II). Eligible pts received conventional TACE treatment within 1-2 months after hepatectomy, and on the 4th day after TACE treatment, oral anlotinib (12mg, qd, 2 weeks on 1 week off) was given until disease recurrence or unacceptable toxicity. The predefined sample size was 30. The primary endpoint was disease free survival (DFS). Secondary endpoints included 1-year DFS rate, time to recurrence and safety. Results: At January 15, 2023, 29 pts were enrolled and 28 pts were available for prognostic assessment, among whom, 11 pts were still on treatment and 9 relapsed, 3 withdrew the consent, 5 discontinued own to intolerable adverse reactions. The longest duration of treatment is 27.83 months. The median DFS has not reached yet and the 1-year DFS rate was 76.46% (95% CI: 54.83~88.70) and 2-year DFS rate was 65.41% (95% CI: 41.70~81.39). Safety profile indicated that 18 pts (64.3%) experienced treatment-related adverse events (TRAEs). Grade 3 TRAEs were detected in 5 pts (17.9%) including hypertension (7.1%), leukocytopenia (7.1%) and ascites (3.6%). No grade 4 or 5 TRAEs were observed. Conclusions: Anlotinib combined with TACE as adjuvant therapy in pts with HCC at high recurrent risk exhibited promising prognosis and tolerable safety profile preliminarily, and the conclusion needed to be confirmed in large-scale clinical trials subsequently. Clinical trial information: NCT04213118 .
Real-world (RW) treatment and surveillance patterns in patients with hepatocellular carcinoma (HCC) after resection (R) or ablation (A): Evidence from commercial and Medicare populations.
Authors: Tan Amie , Schuldt Robert , Ogale Sarika , Hernandez Painter Sairy 
Published: June 2023

e16223 Background: Prognosis of early HCC after curative resection (R) or ablation (A) remains poor due to lack of approved standard of care for adjuvant therapy. Guidelines recommend that patients (pt) receive surveillance imaging every 3 to 6 months for the first 2 years after R or A. RW data on treatment and surveillance patterns after curative intent therapy in the US can provide insights into how novel therapies may be integrated into the treatment paradigm. Methods: We conducted two retrospective, population-based studies of newly diagnosed HCC pts who underwent R or A as the first HCC therapy using data from Pharmetrics Plus commercial claims (2018 - 2021) and SEER-Medicare data (2010 - 2019), respectively. Continuous enrollment in health plans ≥6 months prior to diagnosis (Dx) date and ≥3 months after R or A, and no transplant during study period, was required. Treatments received within 3 months following R or A were defined as adjuvant therapy. Results: Among 705 eligible HCC pts with commercial insurance coverage, the majority were male (73%) and mean (SD) age at Dx was 61(9) years. Among them, 56% received A, 32% received R, and 12% had both R and A after Dx. 126/705 (18%) pts received adjuvant therapy. Most commonly used treatments were systemic therapy (44%) followed by transarterial chemoembolization (TACE) or transarterial embolization (TAE) (41%). Only 20% of pts received surveillance imaging in the first 2 years following R or A (Table). A total of 2,005 Medicare beneficiaries with HCC were identified from SEER-Medicare (male: 67%; White: 68%; Black: 11%; Asian: 19%). Mean (SD) age at Dx was 70(8) years. Among them, 54% received A, 36% received R, and 10% received both as the initial therapy for HCC. 238/2,005 (12%) pts received adjuvant therapy. Most commonly used treatments were TACE/TAE (61%) followed by systemic therapy (29%). Unlike the commercial insurance cohort, the majority of pts in the Medicare cohort (78%) received surveillance imaging within 2 years following R or A. Conclusions: Despite lack of clinical evidence and approved adjuvant therapy in the US, notable use of treatment in RW practice were observed. Types of adjuvant therapy used and utilization of surveillance varied by payers. A significant proportion of pts did not receive ongoing surveillance imaging despite guideline recommendations. These findings highlight the desire and unmet need for clinical evidence of treatments in pts with early HCC following curative intent therapy. [Table: see text]
Impact of surgical treatment on overall survival in cholangiocarcinoma of the gallbladder: An NCDB study.
Authors: Al Kurnas Mohammed , Silberstein Peter T. , Wu Xinxin 
Published: June 2023

e16224 Background: Cholangiocarcinoma (CCA) is a malignancy of the epithelial cells of the biliary tree. Surgical treatment is the preferred treatment option for all subtypes, but 5-year survival rates remain low. The surgical approaches used in the treatment of CCA include radical hepatic resection, laparoscopic, and robotic surgery. Although CCA can arise from the intrahepatic bile duct or extrahepatic bile duct, there exists a subtype with the gallbladder as the primary site. While there have been studies comparing outcomes among surgical procedures, there has yet to be a study that explores the impact of surgery on CCA of the gallbladder. The National Cancer Database (NCDB) was analyzed to determine the effects of surgical modality on overall survival. Methods: A retrospective cohort analysis utilizing the NCDB included 1,880 patients diagnosed with CCA (ICD-8160-3) affecting the gallbladder (topography code C23.9) between 2010 and 2020. Surgical modalities included robotic-assisted, minimally invasive, open, or no surgery. Approaches were categorized by the definitive treatment and open surgeries included procedures converted to open and unspecified. Facility structures were categorized as academic facilities versus non-academic facilities and facility type influence on surgical treatment was compared using Pearson Chi-squared tests. Surgical treatment and facility type on overall survival was analyzed by the Kaplan-Meier method. Results: The majority of the cases analyzed were White (74.7%), female (62.4%), and had Medicare as the primary payor at diagnosis (54.9%). The mean age at diagnosis was 68.4 years (min = 24, max = 90, std. deviation = 11.9) with an average Charlson-Deyo score of 0.5. Of the 1,880 patients analyzed, only 328 underwent surgery (17.4%). There was a statistically significant increase in the overall survival of those who underwent surgery (mean = 33.4 months) over those who did not (mean = 14.7 months, p < 0.001). Those at academic facilities had better overall survival than those at non-academic facilities (p < 0.001), but facility type was not statistically significant for whether patients received surgery. However, those at an academic facility were more likely to have open versus minimally invasive surgery (70.0%) compared to those at a non-academic facility (50.%, p < 0.002). Conclusions: We identified that patients who underwent surgery had significantly better overall survival than those who did not with an average difference of 18.7 months. While there was no difference in the likelihood of having surgery at academic vs. non-academic facilities, the overall survival for those at academic facilities was greater and we found that these patients were more likely to have open surgery over minimally invasive surgery. Further study is needed to determine what other biomedical or socioeconomic factors may account for the difference in overall survival at academic facilities.
Recurrence rate-based strategy to tailor surveillance scheduling in single hepatocellular carcinoma ≤2 cm after curative therapy: Analysis of 6,105 global patients.
Authors: Chen Qi-Feng , Lyu Ning , Zhao Ming 
Published: June 2023

e16225 Background: For initially diagnosed very early-stage hepatocellular carcinoma (HCC, VEH, i.e. single Hepatocellular Carcinoma ≤2 cm), surveillance after surgical resection (SR) or radiofrequency ablation (RFA) remains largely unclear. We conducted this multicenter study to explore optimal surveillance strategies and evaluate the current surveillance strategies for initially diagnosed VEH after SR/RFA to support the clinical follow-up schedule. Methods: A total of 6,105 initially diagnosed VEH patients who received SR/RFA from global centers were included. After the measurement of the recurrence rate of each month, delayed detection times for tumor recurrence of various follow-up strategies were calculated. The candidate strategies were evaluated according to the delayed detection times and the tumor volume doubling time (TVDT), and a preferable surveillance strategy was recommended. Results: The cumulative 1-, 2-, 3-, 4-, and 5-year recurrence probabilities were 12.7%, 25.9%, 35.7%, 43.7%, and 49.3%, respectively. Based on the monthly recurrence rate, programing surveillance schedules were tailored, which were more effective than current surveillance strategies under the same visits. When patients were followed up every 6 months, the delayed recurrence detection after curative treatment was expected to be 2.35 to 2.57 months. Given that 93.3% of patients did not have >TVDT with a rapid growth subtype when recurrent nodules were detected, a surveillance strategy with a 6-month interval was recommended. Conclusions: Six months of interval surveillance was conservatively supported in patients with VEH after curative therapy.