bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dosimetric comparison of target volume coverage and sparing of organs at risk (OARs) between helical intensity modulated radiotherapy (H-IMRT) versus volumetric arc therapy (VMAT) for mid and lower thoracic oesophageal carcinoma.
Authors: Yagnik Vatsala , Batham Samir , Jani Kinjal , Gandhi Maitri , Jain Vega , Rajgor Ruchi , Kothari Jagdish , Parikh Devendra , Lavingia Viraj Kiran , Prajapati Bharat 
Published: January 2023

469 Background: To evaluate the effectiveness of H-IMRT and VMAT in covering target volume while adequately sparing the OARs for patients with mid and distal oesophageal carcinoma, on the basis of dosimetric analysis. Methods: The target areas and organs at risk in 30 patients with locally advanced carcinoma oesophagus undergoing neo-adjuvant chemo-radiotherapy were specified and transmitted to Eclipse, Version 13.6, Varian Medical Systems) & Accuray Treatment Planning System (Accuray Precision, Version 2.1.4, Accuray Medical System). Two plans (H-IMRT and VMAT) were generated for each patient for a total dose of 41.4 Gy delivered to the PTV in 23 fractions, and the Homogeneity Index (HI), Conformity Index (CI) and the dose distribution to the OARs (spinal cord, heart, lungs, kidneys and liver) were compared using dose volume histograms. Results: H-IMRT resulted in a more homogeneous dose distribution to the target (HI- 0.059) as compared to VMAT (HI- 0.07) [p-0.004]. The Conformity Indices showed no significant difference between the two techniques (H-IMRT – 0.989, VMAT – 0.987) [p-0.66]. VMAT resulted in a significantly less dose to the spinal cord (23.598 Gy vs .25.657 Gy) [p-0.021]. With VMAT plans, the heart mean dose (18.101 Gy vs. 20.031) [p- 0.00007], heart V40 (4.902% vs. 6.143) [p-0.002,] the averaged lung V20 [p-0.00005] and the mean dose to the left kidney (3.84 Gy vs. 4.721 Gy) [p- 0.010] were significantly less as compared to H-IMRT No statistically significant difference in both techniques with respect to heart V30, Mean Lung Dose (MLD), and mean dose to the righ and left kidney was observed Conclusions: VMAT proved to be better at sparing of OARs whilst providing almost the same Conformity as compared to a H-IMRT. H-IMRT has statistically better dose homogeneity but, it tends to deposit a slightly higher dose to the OARs. Whether the aforementioned differences in the dosimetric parameters translate into clinical benefits has to be evaluated by clinical outcome studies.
Adjuvant transarterial chemoembolization with sorafenib for patients with hepatocellular carcinoma with portal vein tumor thrombus after surgery: A phase III, multicenter, randomized, controlled trial.
Authors: Kuang Ming , Peng Zhenwei , Fan Wenzhe , Liu Zelong , Xiao Han , Tu Jianfei , Tang Rong , Huang Zhen , Cheng Yu , Li Fuliang , Lu Mingjian , Li Jiaping 
Published: January 2023

493 Background: To compare the efficacy and safety of sorafenib plus transarterial chemoembolization (SOR-TACE) versus sorafenib alone as postoperative adjuvant therapy for hepatocellular carcinoma (HCC) patients with portal vein thrombus (PVTT). Methods: This was a phase III, multicenter, randomized, control clinical trial. Eligible HCC patients with PVTT were included and randomly assigned (1:1) to receive SOR-TACE or sorafenib alone as postoperative adjuvant therapy. Sorafenib treatment was started within 3 days after randomization, with an initial dose of 400mg twice a day. In the SOR-TACE group, TACE was performed one day after the administration of sorafenib. The primary endpoint was recurrence-free survival (RFS). Results: From October 2019 to March 2022, a total of 158 HCC patients with PVTT from China were enrolled and randomized. After a median follow-up duration of 28.4 months, the median RFS was significantly longer in the SOR-TACE group (16.8 vs. 12.6 months; hazard ratio, 0.57; P = 0.002). The median overall survival (OS) was also significantly longer with SOR-TACE than with sorafenib (30.4 vs. 22.5 months; hazard ratio, 0.57; P = 0.017). Multivariable analysis indicated SOR-TACE treatment was an independent risk factor for both RFS and OS. The SOR-TACE group did not show additional toxicity compared with the sorafenib alone group. Conclusions: The combination of sorafenib and TACE as postoperative adjuvant therapy in HCC patients with PVTT resulted in longer RFS and OS compared to sorafenib alone and was well tolerated. Clinical trial information: NCT04143191 .
Cost-effectiveness of gemcitabine plus cisplatin with and without durvalumab in patients with advanced cholangiocarcinoma.
Authors: Maldonado J. Alberto , Greten Tim F. , Monge B. M. Cecilia 
Published: January 2023

498 Background: Based on the results from the TOPAZ-1 study, current standard of care treatment for patients with advanced biliary tract cancer is gemcitabine and cisplatin (Gem/Cis) plus durvalumab (Durva). The addition of Durva improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Considering that the epidemiology of cholangiocarcinoma may indicate some racial and ethnic groups may have a higher incidence and poorer prognosis; we present a cost analysis of this new treatment option. Methods: We calculated the unit prices of Durva and Gem/Cis with the information provided by the LexiComp (accessed September 2022). The drug cost per cycle was calculated for each drug; assuming an average patient surface area of 1.9m2 for men and 1.6m2 for women. In both cases, the chosen vial was the same and, thus, pricing was the same. Costs of administration, adverse effect and follow up were excluded. As per the TOPAZ-1 study design, the first 8 cycles included either Durva (day 1) + Gem/Cis (days 1 and 8) or placebo (day 1) + Gem/Cis (days 1 and 8) every 3 weeks, followed by Durva or placebo alone every 4 weeks until disease progression. The total treatment cost was composed of the sum of all treatment cycles received on study. Cost per life year gained was calculated using the total cost per year in each group and treatment duration as the denominator. Results: Cost per cycle for Durva, Gem, and Cis was $13,797, $282, and $87, respectively. The patients in the TOPAZ-1 trial who were randomized to the Durva arm had a median treatment duration of 7.3 months while patients in the Gem/Cis arm had a median treatment duration of 5.8 months. PFS was similar with a median time of 7.2 months and 5.7 months, respectively. This difference in both treatment duration and PFS (both 1.5 months) was associated with an increased cost of $124,170 over the course of treatment for Durva + Gem/ Cis compared to Gem/Cis alone ($127,119 vs $2,949). Durva + Gem/Cis has a medication only cost of $1,655,604 per life year gained as compared to Gem/Cis alone. Total yearly cost by treatment arm was higher for the Durva + Gem/Cis group ($209,899 vs $2,949). Conclusions: Durvalumab combined with gemcitabine and cisplatin is associated with an increase of 1.5 months in both treatment duration and PFS without additional toxicity observed when compared to Gem/Cis alone; however, Durva + Gem/Cis was associated with a drug cost over 40 times higher when compared Gem/ Cis alone for first-line treatment of advanced biliary tract cancer. Further research should focus on cost-effective solutions to treat advanced cholangiocarcinoma.
Prevalence of historical medical conditions or comorbidities with potential role in clinical decision making related to suitability of immuno-oncologic plus IV antiangiogenic therapy in newly diagnosed first-line unresectable hepatocellular carcinoma in the United States.
Authors: Schuler Tammy , Passos Chaves Leonardo , Kamble Shital , Bland Emily , Feinberg Bruce A. 
Published: January 2023

511 Background: Treatment landscape in advanced/unresectable hepatocellular carcinoma (uHCC) has been rapidly changing. In June 2020, the first immuno-oncologic (I/O) + IV anti-angiogenic regimen for uHCC was approved as first line (1L) treatment in the US. As with any new therapy, it is key to understand the prevalence of medical conditions listed in patient medical history/comorbidities that could potentially influence physician choice of 1L therapy in uHCC patients. Methods: We conducted a retrospective chart review study using Cardinal Health's Oncology Provider Extended Network (OPEN). US medical oncologists identified newly diagnosed adult uHCC patients initiating 1L systemic therapy from June 2020 to April 2022. Based on the warnings and precautions section of the US FDA labels, medical conditions reported as part of patient medical history or comorbidities [including gastrointestinal (GI) bleeding risk, chronic kidney disease, autoimmune disorders, thromboembolic events] were identified from patient medical records. Less suitable was defined as the occurrence of ≥ 1 medical condition/comorbidity reported in the medical record. All patient data were deidentified. Proportions of patients with the above medical conditions or with physician-reported record of an esophagogastroduodenoscopy (EGD) procedure to assess risk of bleeding were calculated. Results: In the cohort of 433 uHCC patients initiating 1L systemic therapy, majority were male 287 (66%), Caucasian 244 (56%) with average age of 64 years. At 1L initiation, majority of the patients were 333 BCLC Stage C (77%) and 316 (73%) had ECOG performance status of 0 or 1. Approximately 160 (37%) were Child-Pugh B, 99 (23%) had non-alcoholic steatohepatitis (NASH), 176 (41%) had Hep-C etiology (among those tested), and 294 (68%) had liver cirrhosis. Prior to therapy initiation, 254 (59%) received EGD within 3 months. In the overall cohort, 221 (51%) patients were reported to have at least one condition listed as medical history/comorbidity that could make them less suitable to receive I/O + IV anti-angiogenic regimen. Upper/lower GI bleeding risk and chronic kidney disease were reported in 164 (38%) and 64 (15%) patients, respectively. History of thromboembolic events and autoimmune disorders were reported in 50 (12%) and 22 (5%) of patients, respectively. Conclusions: A significant proportion of the newly diagnosed uHCC patients were found to have at least one condition listed as medical history/comorbidity that would make them potentially less suitable for I/O + IV anti-angiogenic regimen. Our findings reinforce the importance of medical history and co-morbidity assessment in uHCC patients prior to therapy selection to optimize benefit-risk ratio for each patient.
Clinical and prognostic utility of ALBI versus Child-Pugh score in a Mexican population with hepatocellular carcinoma.
Authors: Diaz Romero Maria del Consuelo , Zilli Hernandez Stefan , Calderillo Ruiz German , Camacho Sanchez Ana Zyanya Xcaret , Carbajal Berenice , Herrera Marytere , Ruiz-Garcia Erika , Miyagui-Adame Sayako Mariana 
Published: January 2023

517 Background: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide. The assessment of liver function is crucial in determining the prognosis of patients. Aim: To compare the utility of the ALBI and CHILD-PUGH scores in predicting the prognosis and treatment of patients with hepatocellular carcinoma at the National Cancer Institute, Mexico. Methods: Retrospective, observational study. Included patients diagnosed with HCC and treated at the National Cancer Institute 2008-2021. Statistical analysis included: X2 and t-test, Kaplan Meier, Log Rank, and Cox Regression. Statistical significance was assessed when p was bilaterally <0.05. Results: A total of 315 patients diagnosed with HCC were included, mostly male (61%) with a median age of 67 years, mostly in the advanced stages of the disease (90%). Regarding liver functionality scores, of the patients who were scored in CHILD-PUGH-A5 (n=124), 53% were in ALBI G1, while 47% scored ALBI G2. Regarding the CHILD-PUGH-A6 group (n=92) only 71% of patients scored ALBI G2, and among CHILD-PUGH-B7 score (n=55) patients, only 13% scored in the ALBI G3 group (p<0.001). In survival analysis, CHILD-PUGH-A5 patients had a median OS of 40 months, while CHILD-PUGH-A6 patients showed a median OS of 11 months (p<0.001). Patients with a CHILD-PUGH-B7 score showed a median OS of 10 months compared to patients with a CHILD-PUGH-B8 score who showed a median OS of 4 months (p=0.93). Among ALBI score, G1 patients did not reach median OS, while the median OS of patients with G2 and G3 was 13 and 4 months respectively (p<0.001). At Univariate analysis, histology (HR:1.22; p=0.021), bilirubin (HR:1.12; p<0.001), albumin (HR:0.33; p<0.001), CHILD-PUGH (HR:1.27; p<0.001), ALBI (HR:2.91; p<0.001), ECOG (HR:1.82; p<0.001), surgery (HR:2.24; p=0.029) and systemic treatment (HR:2.57; p<0.001) showed statistical differences. While only albumin (HR: 0.45; p=0.027), ECOG (HR: 1.49; p=0.006), systemic treatment (HR: 1.78; p=0.026) and ALBI score (HR: 1.71; p=0.032) remained predictors of OS. Conclusions: The study demonstrates that ALBI score presents a better prognostic and liver function stratification than CHILD-PUGH score in Mexican population.
Real-world dosing of regorafenib in patients with unresectable hepatocellular carcinoma (uHCC): Final analysis of the prospective, observational REFINE study.
Authors: Finn Richard S. , Merle Philippe , Ikeda Masafumi , Klümpen Heinz-Josef , Masi Gianluca , Granito Alessandro , Lim Ho Yeong , Kudo Masatoshi , Qin Shukui , Gerolami René , Huang Yi-Hsiang , Kim Do Young , Pinter Matthias , Kato Naoya , Kurosaki Masayuki , Numata Kazushi , Khan Javeed , Ozgurdal Kirhan , Kim Yoon Jun 
Published: January 2023

518 Background: Final results from the real-world REFINE study confirmed the safety and effectiveness of regorafenib (REG) in a broad population of patients (pts) with uHCC that was consistent with the results from RESORCE, in which REG prolonged overall survival (OS) vs placebo in pts with uHCC who progressed on prior sorafenib. Here we evaluate baseline characteristics and outcomes according to the initial REG dose. Methods: REFINE (NCT03289273), an international, prospective, multicenter study, enrolled pts with uHCC for whom a decision to treat with REG was made by the treating physician prior to enrollment according to the local health authority approved label (160 mg/day, 3 weeks on/1 week off). The primary objective was safety (NCI-CTCAE v4.03); secondary endpoints included OS and progression-free survival (PFS). Results: Of 1005 pts eligible for analysis, 47%, 11%, 40%, and 3% initiated REG at 160 mg, 120 mg, 80 mg, and 40 mg, respectively. A higher proportion of pts from Asia initiated REG at 160 mg (51%) vs non-Asian countries (42%), and 67% were Child–Pugh A in Asia vs 54% in non-Asian countries at study entry. Pts initiating REG at 160 mg were more likely to be Child–Pugh A and albumin–bilirubin (ALBI) grade 1 vs pts initiating REG at <160 mg (Table). A higher proportion of pts (53%) who initiated REG at 160 mg ended prior sorafenib at 800 mg/day. Of the pts intolerant to prior sorafenib (n=91), more pts started REG at 80 mg (49%), followed by 160 mg (32%) and 120 mg (9%). Median duration of REG treatment was similar across initial dose levels (overall 3.7 months). Any-grade TEAEs were reported for 90%, 93%, and 93% of pts initiating REG at 160 mg, 120 mg, and 80 mg, respectively. TEAEs led to dose modifications in 49%, 51%, and 38% and to dose reductions in 34%, 26%, and 17% of pts. Median OS was 15.8 months in pts who initiated REG at 160 mg, 13.3 months at 120 mg, and 11.1 months at 80 mg. Median PFS was similar across doses (overall 3.9 months). Conclusions: In this real-world study, most pts with uHCC initiated REG at 160 mg or 80 mg/day. A higher proportion of pts from Asia initiated REG at the recommended dose, and a higher proportion of pts initiating REG at 160 mg had relatively better liver function at study entry. Safety was generally similar regardless of initial dose, and OS was observed to be longer in pts initiating REG at 160 mg vs lower doses. Clinical trial information: NCT03289273 . [Table: see text]
The real-world prevalence of esophagogastric varices, bleeding, emergency room visits, and hospitalization among patients with advanced hepatocellular carcinoma in the US.
Authors: Parikh Neehar , Yu Shengsheng , Park Noh Jin , Locker Michael , Chopra Ishveen , Yeaw Jason 
Published: January 2023

519 Background: Upper gastrointestinal bleeding associated with esophagogastric varices (EGV) is a morbid and potentially deadly complication of advanced hepatocellular carcinoma (aHCC). However, the presence of EGV among the aHCC population receiving esophagogastroduodenoscopy (EGD) in the US is not well understood, nor are the predictors of EGV- or bleeding-related ER or hospitalization (the outcome) among those who are newly initiated on systemic treatment. Methods: A retrospective cohort analysis was conducted utilizing IQVIA’s PharMetrics Plus Health Plans Claims database (January 1, 2016, to July 31, 2021). Patients ≥18 years of age with ≥1 prescription for an aHCC systemic treatment were included; the date of the first prescription was the index date. At least 12 months of continuous enrollment pre-index and 6 months post-index (unless patients were deceased) were required. Patients with pre-index diagnosis codes for renal cell carcinoma, differentiated thyroid carcinoma, colorectal cancer, gastric cancer, non-small cell lung carcinoma, and liver transplant were excluded. Logistic regression was conducted to identify associations between baseline characteristics and the outcome. Results: A total of 904 patients with aHCC were included (mean age: 61.3 years; 75.3% male); 39.4% of patients died within 6 months following the index date. During the pre-index period, 688 (76.1%) patients had portal hypertension-related comorbidity, 327 (36.2%) had EGD, 122 (13.5%) had EGV, and 63 (7.0%) had bleeding. During the observational period, 458 (50.7%) patients received EGD, among whom 209 (45.6%) also had EGV. 141 (15.6%) patients had ≥1 outcome event during the post-index period. In the adjusted analysis, patients with pre-index bleeding and with EGV but no bleeding had 4.5- and 3.1-times higher odds of having post-index outcome, respectively, as compared with those lacking pre-index bleeding and EGV. Moreover, the pre-index presence of portal hypertension-related comorbidities was associated with 3.1 times greater odds of having a post-index outcome. Conclusions: EGV and bleeding events are common in patients with aHCC receiving systemic therapies. The EGV prevalence of 45.6% among those receiving EGD is consistent with prior similar studies outside of the US (Giannini EG, et al. Clin Gastroenterol and Hepatol. 2006; Iavarone M, et al. United European Gastroenterol J. 2016; Hsieh WY, et al. Sci Rep. 2017). The presence of bleeding, EGV, and portal hypertension-related comorbidities prior to treatment initiation were associated with the increased post-treatment risk of EGV- or bleeding-related ER or hospitalization in these patients. To our knowledge, this is the first study to assess and report the presence of EGV among those receiving EGD in a US aHCC population.
Treatment patterns and oncologic outcomes of carcinoma of the ampulla of vater in a reference hospital in a middle income country: A real-world–based study.
Authors: Dip Borunda Abdel Karim , Arteaga Garcia Ricardo Jesus , Barragan Los Santos Javier , Medrano Guzman Rafael , Leal Sosa Alvaro , Pimentel Alfonso 
Published: January 2023

524 Background: Gallbladder and other biliary tract tumors account for 0.6 % of all cancers. There is scarce data of Ampullary cancers, but it is known as an extremely rare neoplasia accounting just for 0.2% of gastrointestinal cancers and 7% of periampullary tumors. Most frequent histology is adenocarcinoma being intestinal and pancreatobiliary subtypes conditioning prognosis and treatment. Current approaches include, but not limited to: neo/adyuvant, radiation and palliative therapy. Methods: We conducted a retrospective study in a referral specialized center in Mexico city. We included patients with histologically confirmed ampullary cancer treated between 2008 and 2022, stages I-IV. We evaluated the frequency of surgery, radiation therapy and chemotherapy. Also, we registered, first line, subsequent and maintenance therapy and as for radiation and chemoradiation. Chi square and student T test were used for between group comparisons. Overall survival was performed using the Kaplan Meier method. Results: We included 220 patients with a median age of 60.3 years (range 28-84), female 51.8%. The clinical stage distribution was I 10%, II 16.4%, III 41.3%, IV 32.3%. Performance status 0 (26.5%), 1 (44.5%), 2 (15.6%), 3 (10.4%), 4 (2.8%). Histologic Subtype Adenocarcinoma not otherwise specified 45.7%, Intestinal Adenocarcinoma 27.1%, Pancreatobiliary Adenocarcinoma 16.7%, Mix Intestinal-Pancreatobiliary 6.2%, Signet Ring Cell Adenocarcinoma 2.4%, Neuroendocrine 1.9%. Curative intend surgery in 169 patients was possible in 90%. Initial treatment received was Adjuvant 40.9%, Palliative 27.7%, Neoadjuvant 2.3% and Never Received any kind of treatment in 29.1%. Adjuvant Treatment was given to 94 patients. Among them Gemcitabine and Capecitabine was the election of treatment in 34% and 23.4 respectively. First line Treatment. Patients receiving first line treatment (110 patients) were candidates to Gemcitabine, XELOX, and Gemcitabine-Cisplatin in 30%, 13.6% and 12.7% according to physicians and 56% other line of treatment. Patients who progressed to first line received a second line in 19%. Most frequent second line of treatment was Capecitabine 61.9% and Gemcitabine 23.8%. Of the whole population Median Overall Survival was 30.68 months, Disease Free survival: 30.71 months and 8.0 months for progression free survival in first line. Conclusions: To our knowledge first real world based large volume study reporting treatment patterns and oncologic outcomes of a rare entity.