scholarly journals Comparison between Y90 Radioembolization Plus Sorafenib and Y90 Radioembolization alone in the Treatment of Hepatocellular Carcinoma: A Propensity Score Analysis

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 897
Author(s):  
Antonio Facciorusso ◽  
Irene Bargellini ◽  
Marina Cela ◽  
Ivan Cincione ◽  
Rodolfo Sacco

Background: Adjuvant sorafenib may enhance the efficacy of transarterial radioembolization with yttrium-90 in hepatocellular carcinoma patients. The aim of this study is to assess the efficacy and safety of radioembolization plus sorafenib in comparison to radioembolization alone. Methods: Out of 175 hepatocellular carcinoma (HCC) patients treated with radioembolization between 2011 and 2018, after propensity score matching, two groups were compared: a group of 45 patients that underwent radioembolization while being on sorafenib (Group 1) and a second group of 90 patients that underwent radioembolization alone (Group 2). Results: Baseline characteristics of the two groups were well balanced concerning liver function and tumor burden. No significant differences in survival outcomes were identified (median overall survival 10 vs. 10 months; p = 0.711), median progression-free survival 6 vs. 7 months (p = 0.992) in Group 1 and Group 2). The objective response rate in Group 1 vs. Group 2 was 45.5% vs. 42.8% (p = 1) according to mRECIST. No differences in toxicity nor in liver decompensation rates were registered. Conclusions: The association of sorafenib does not prolong survival nor delay progression in patients treated with radioembolization. Liver toxicity does not differ among the two therapeutic schemes.

Diagnostics ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. 791
Author(s):  
Antonio Facciorusso ◽  
Antonio Turco ◽  
Carlo Barnabà ◽  
Grazia Longo ◽  
Graziano Dipasquale ◽  
...  

In spite of promising preliminary results, evidence supporting the use of non-anesthesiologist-administered propofol sedation (NAAP) in endoscopic ultrasound (EUS) procedures is still limited. The aim of this manuscript was to examine the safety and efficacy of NAAP as compared to anesthesiologist-administered propofol sedation in EUS procedures performed in a referral center. Out of 832 patients referred to our center between 2016 and 2019, after propensity score matching two groups were compared: 305 treated with NAAP and 305 controls who underwent anesthesiologist-administered propofol sedation. The primary outcome was the rate of major complications. The median age was 67 years and the proportion of patients with comorbidities was 31.8% in both groups. One patient in each group (0.3%) experienced a major complication, whereas minor complications were observed in 13 patients in the NAAP group (4.2%) and 10 patients in the control group (3.2%; p = 0.52). Overall pain during the procedure was 2.3 ± 1 in group 1 and 1.8 ± 1 in group 2 (p = 0.67), whereas pain/discomfort upon awakening was rated as 1 ± 0.5 in both groups (p = 0.72). NAAP is safe and effective even in advanced EUS procedures. Further randomized-controlled trials (RCTs) are warranted to confirm these findings.


2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Liang-He Lu ◽  
Wei-Wei ◽  
Anna Kan ◽  
Jie-Mei ◽  
Yi-Hong Ling ◽  
...  

Background. Gamma-glutamyltransferase (GGT) is involved in tumor development and progression, but its prognostic value in α-fetoprotein- (AFP-) negative (AFP<25 ng/mL) hepatocellular carcinoma (HCC) patients remains unknown. Methods. A large cohort of 678 patients with AFP-negative HCC following curative resection who had complete data were enrolled in this study. The optimal cutoff value for the preoperative level of GGT was determined by the X-tile program. Independent prognostic factors for overall survival (OS) and disease-free survival (DFS) were also identified. Results. The optimal cutoff values for the preoperative levels of GGT were 37.2 U/L and 102.8 U/L, which were used to divide all patients into three subgroups (group 1, GGT<37.2 U/L (n=211, 31.1%); group 2, GGT≥37.2 and <102.8 U/L (n=320, 47.2%); group 3, GGT≥102.8 U/L (n=147, 21.7%)), with distinct OS times (58.5 vs. 53.5 vs. 44.4 months, P<0.001) and DFS times (47.9 vs. 40.3 vs. 30.1 months, P<0.001). Elevated preoperative GGT levels were associated with an unfavorable tumor burden (larger tumor size, multiple tumors, and microvascular invasion) and were selected as independent predictors of a worse OS (group 2 vs. group 1, HR: 1.73 (1.13-2.65), P=0.011; group 3 vs. group 1, HR: 3.28 (2.10-5.13), P<0.001) and DFS (group 2 vs. group 1, HR: 1.52 (1.13-2.05), P=0.006; group 3 vs. group 1, HR: 2.11 (1.49-2.98), P<0.001) in multivariable analysis. Conclusions. Elevated preoperative GGT levels are associated with an unfavorable tumor burden and serve as an independent prognostic marker for worse outcomes in AFP-negative HCC patients following resection.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
El-Sayed A. Fayad ◽  
Mohamed A. Amr

Abstract Background Surgical management of extensively diseased left anterior descending artery (LAD) is challenging. Reconstruction of the LAD with endarterectomy may lead to intimal disruption and affect the outcomes of surgery. We aimed to compare hospital outcomes of surgical reconstruction of extensively diseased LAD with and without endarterectomy. Results This retrospective multicenter study included 275 patients who had reconstruction of extensively diseased LAD from 2015 to 2019. We divided patients into two groups: group 1 (n = 138) included patients who had plaque exclusion and patching, and group 2 (n = 137) included patients who had endarterectomy and patching. All patients had primary isolated on-pump coronary artery bypass grafting with the left internal mammary artery (LIMA) grafting to LAD. On-lay LIMA patch was used in 118 patients in group 1 and 132 patients in group 2. A saphenous vein patch was used in 20 patients in group 1 and 5 patients in group 2. Propensity score matching identified 100 matched pairs. The age in group 1 was 56.1 ± 7.8 years versus 55.2 ± 7.1 in group 2 (P = 0.34). There were 119 (86.2%) males in group 1 and 113 (82.5%) in group 2 (P = 0.39). After matching, there was no difference in preoperative and operative data. In the matched groups, low cardiac output occurred in 6 (6%) patients in group 1 and 4 (4%) patients in group 2 (P = 0.73). There was no difference in mechanical ventilation time between groups (9 (25th- 75th percentiles: 7.5–14) hours in group 1 vs. 9 (7–14) hours in groups 2; P = 0.93). Length of hospital stay was 7 (6–9) days in group 1 and 7 (6–10) days in group 2 (P = 0.57). Mortality occurred in one patient in group 1. We did not report early graft occlusion cases in group 1, and one patient had a myocardial infarction in group 2. Conclusion The outcomes after reconstructing extensively diseased LAD with endarterectomy or plaque exclusion and patching are satisfactory and comparable in both approaches.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18108-e18108
Author(s):  
Natalie Maimon ◽  
Daniel Keizman ◽  
Maya Gottfried

e18108 Background: The EGFR inhibitor erlotinib is a standard second line tx for mNSCLC. Statins are used in the tx of hyperlipidemia. Pre-clinical and clinical studies in several cancer types have shown that they may inhibit tumor growth. Their effect on the outcome of erlotinib as second line tx in mNSCLC is poorly defined. We aimed to study the effect of statins on the outcome of erlotinib as second line tx for mNSCLC. Methods: We performed a retrospective study of an unselected cohort of pts with mNSCLC, who were treated continuously with 150mg of oral erlotinib. Pts were divided into 2 groups: (1) statins users and (2) statins naive. The effect of statins use on objective response, progression free survival (PFS) and overall survival (OS), was tested with adjustment of other known confounding risk factors using a chisquare test and partial likelihood test from cox model. Results: Between 2005-2011, 107 pts with mNSCLC were treated with second line erlotinib. There were 51 statins users (group 1) and 56 nonusers (group 2). All users started statins before erlotinib tx initiation. The groups were balanced regarding the following known clinical prognostic factors: female gender, ECOG performance status, active smoking, anemia, adenocarcinoma histology type, EGFR mutation (positive vs negative + unknown). Objective response in group 1 vs 2 was partial response (PR) 41% vs 29% (p=0.15), stable disease (SD) 41% vs 25% (p=0. 11), and progressive disease (PD) 18% vs 46% (OR=2.5, p=0.07). Median PFS was 12 vs 3 ms (HR 0.44 in statins users, p=0.02). Median OS was 35 vs 19 ms (HR 0.63, p=0.1). Conclusions: Statins may improve the outcome of pts with mNSCLC that are treated with erlotinib as second line tx. This should be investigated prospectively, and if validated, applied in clinical practice and clinical trials.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16192-e16192
Author(s):  
Qicong Mai ◽  
Song Chen ◽  
Feng Shi ◽  
Zhiqiang Mo ◽  
Jian He ◽  
...  

e16192 Background: Lenvatinib has been approved as a first-line systemic for advanced hepatocellular carcinoma (HCC) after the randomized phase III REFLECT trial. The aim of this study was to assess the lenvatinib-base treatment patterns and safety in real-world clinical settings in China. Methods: In this multicenter retrospective study, A total of 278 patients with unresectable HCC were treated with lenvatinib-base treatment between October 2018 and November 2020 were analyzed. Therapeutic effect was determined using the RECIST 1.1 and mRECIST criteria. Progression free survival (PFS), overall survival (OS) and treatment-related adverse events (TRAE) were also evaluated. Results: Of 278 unresectable HCC patients (median age: 56.1±11.9 years), 220 (79.1%) had cirrhosis caused by HBV infection. 215 (77.3%) and 63 (22.7%) patients were classified as Child-pugh A and B class, respectively. 233 (83.8%) and 45 (16.2%) patients received lenvatinib in first-line and second-line systemic therapies, respectively. 223 (80.2%) patients were treated with lenvatinib plus arterially directed therapy (TACE or HAIC of FOLFOX) and 55 (19.8%) were treated with lenvatinib alone. The objective response rate were 34.9% (RECIST) and 47.5% (mRECIST), while the disease control rate were 75.5%. With a median follow-up period of 12.8 months, the median PFS and OS were 7.8 months (95% CI 7.1–8.4) and 17.2 months (95% CI 14.9–19.6), respectively. Results from the multivariate analysis showed that the significant independent favorable prognosis factors were tumor burden< 50% (P=0.033), Child–Pugh A class (P<0.01), AFP level <200ng/mL (P=0.045), the combination with lenvatinib and arterially directed therapy (P<0.01). TRAE occurred in 219 of 278 patients (78.8%), most common TRAE were hypertension (n=118; 42.4%) and hand-foot skin reaction (n=91; 32.7%). The most common grade 3–4 TARE were hypertension (n=23; 8.3%), decreased appetite (n=18; 6.5%), AST elevation (n=14; 5%), and diarrhea (n=14; 5%) across all study patients. Conclusions: In this multicenter real-world study, lenvatinib-base treatment could be accomplished with well tolerated and response for unresectable HCC patients. Combination with arterially directed therapy could likely improve the overall survival.


2021 ◽  
Author(s):  
Qinqin Liu ◽  
Jing Li ◽  
Nan You ◽  
Ke Wu ◽  
Xuehui Peng ◽  
...  

Abstract Background: Few studies have evaluated the efficacy and safety of immunotherapy and targeted therapy in combination. The present study aimed to compare camrelizumab plus sorafenib versus sorafenib alone in patients with advanced hepatocellular carcinoma using a propensity score analysis.Patients and methods: Between January 2019 and January 2021, a total of 100 patients with advanced HCC in the Second Affiliated Hospital of Army Medical University were retrospectively analyzed. Of the patients involved, 35 patients received combined camrelizumab plus sorafenib treatment, and 65 patients received sorafenib monotherapy. After 1:1 propensity score matching (PSM), 34 patients were included in each group. The progression-free survival (PFS), overall survival (OS), treatment response and the relevant adverse effects (AEs) were evaluated.Results: The combined-therapy group showed significantly improved overall response rate (ORR) than the sorafenib-only group (before PSM, P=0.037; after PSM, P=0.010), but no difference was noted in disease control rate (DCR) (before PSM, P=0.695; after PSM, P=1.000). The median PFS was significantly longer in the combined-therapy group than the sorafenib-only group (before PSM, P=0.041; after PSM, P=0.043). However, the two groups exhibited comparable median OS (before PSM, P=0.135; after PSM, P=0.105). Although The incidence of thrombocytopenia after PSM was significantly higher in the combined-therapy group than in the sorafenib-only group, most of the AEs could be easily controlled after treatment.Conclusion: The combination treatment of camrelizumab with sorafenib showed promising efficacy with acceptable safety for the management of advanced HCC.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 305-305 ◽  
Author(s):  
Jean Philippe Metges ◽  
Jean François Ramée ◽  
Jean-Yves Douillard ◽  
Eveline Boucher ◽  
Roger Faroux ◽  
...  

305 Background: FOLFIRINOX, one of the gold standard in metastatic pancreatic cancer as first-line therapy for patients under 76 years with PS 0-1, good haematological and renal function and a subnormal bilirubin level (Prodige 4 criteria), was analysed in Brittany (B) and Pays de la Loire (PL) in routine clinical practice. Methods: Our aim is to evaluate the use of Folfirinox between July 2010 and December 2012 in B/PL. Results: Data of 340 patients have been studied (198 men, median age 63 years [29-81]). 208 patients were metastatic at diagnosis (liver 67%). 62 primary tumors were resected and 51 patients had received previous adjuvant chemotherapy (gemcitabine, n=48). The median progression free survival PFS and overall survival OS were respectively 6.80 months IC95% [6.18-7.43] and 10.97 months IC 95% [9.56-11.83]. Patients could be divided into 4 groups : Group 1 composed of patients treated according to Prodige 4 trial (n=242), Group 2 1st line metastatic patients with at least one Prodige 4 non-eligibility criterion (n=25), Group 3 locally advanced patients (n=59) and Group 4 by Folfirinox in 2ndline (n=14). The median number of cycles was 9 [1-27] in Group 1 and 6 [1-12] in Group 2. Clinical benefit was 65% (group 1) vs 56% (group 2). During treatment, 81% of patients had a dose adjustment (Group 1) vs 72% (Group 2) and 32% vs 40% presented grade III/IV toxicity (mostly neuro- or haematotoxicity). Median PFS were respectively in Group 1 vs Group 2 : 6.54 months IC95% [5.98-7.29] vs 4.14 [1.68-6.21] (p=0.0107) and median OS :10.91 months IC 95% [8.94-12.02] vs 7.0 IC95% [4.01-11.20] (p=0.0166). For Group 3 and 4, median OS were respectively 11.24 months [10.0-15.01] vs 11.50 [4.83-14.09]. Others results will be shown at the meeting. For Group 1, stopping treatment before progression induced significatively better median PFS and OS than going on treatment until progression : PFS : 8.25 IC95[7.52-8.74] vs 3.48. IC95 [3.09-4.44] (p<0.0001) and OS : 12.78 months IC95 [11.60-15.54] vs 7.62 IC95 [6.44-9.49] (p<0.0001). Conclusions: Our results for Group 1 are relatively consistent with those of Prodige 4: objective response rate (39% vs 32%), PFS (6.5 vs 6.4 months) and OS (10.9 vs 11.1 months). Non eligibity for Prodige 4’s criteria decreases PFS and OS significantly.


Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 812
Author(s):  
Gaël S. Roth ◽  
Maxime Benhamou ◽  
Yann Teyssier ◽  
Arnaud Seigneurin ◽  
Mélodie Abousalihac ◽  
...  

No definitive conclusion could be reached about the role of chemotherapy in adjunction of embolization in the treatment of hepatocellular carcinoma (HCC). We aim to compare radiological response, toxicity and long-term outcomes of patients with hepatocellular carcinoma (HCC) treated by trans-arterial bland embolization (TAE) versus trans-arterial chemoembolization (TACE). We retrospectively included 265 patients with HCC treated by a first session of TACE or TAE in two centers. Clinical and biological features were recorded before the treatment and radiological response was assessed after the first treatment using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Correlation between the treatment and overall, progression-free and transplantation-free survival was performed after adjustment using a propensity score matching: 86 patients were treated by bland embolization and 179 patients by TACE, including 44 patients with drug-eluting beads and 135 with lipiodol TACE, 89.8% of patients were male with a median age of 65 years old. Cirrhosis was present in 90.9% of patients with a Child Pugh score A in 84% of cases. After adjustment, no difference in the rate of AE, including liver failure, was observed between the two treatments. TACE was associated with a significant increase in complete radiological response (odds ratio (OR) = 8.5 (95% confidence interval (CI): 2.8–25.4)) but not in the overall response rate (OR = 2.2 (95% CI = 0.8–5.8)). No difference in terms of overall survival (p = 0.3905), progression-free survival (p = 0.4478) and transplantation-free survival (p = 0.9020) was observed between TACE and TAE. TACE was associated with a higher rate of complete radiological response but without any impact on overall radiological response, progression-free survival and overall survival compared to TAE.


2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Christina Scharf ◽  
Ines Schroeder ◽  
Michael Paal ◽  
Martin Winkels ◽  
Michael Irlbeck ◽  
...  

Abstract Background A cytokine storm is life threatening for critically ill patients and is mainly caused by sepsis or severe trauma. In combination with supportive therapy, the cytokine adsorber Cytosorb® (CS) is increasingly used for the treatment of cytokine storm. However, it is questionable whether its use is actually beneficial in these patients. Methods Patients with an interleukin-6 (IL-6) > 10,000 pg/ml were retrospectively included between October 2014 and May 2020 and were divided into two groups (group 1: CS therapy; group 2: no CS therapy). Inclusion criteria were a regularly measured IL-6 and, for patients allocated to group 1, CS therapy for at least 90 min. A propensity score (PS) matching analysis with significant baseline differences as predictors (Simplified Acute Physiology Score (SAPS) II, extracorporeal membrane oxygenation, renal replacement therapy, IL-6, lactate and norepinephrine demand) was performed to compare both groups (adjustment tolerance: < 0.05; standardization tolerance: < 10%). U-test and Fisher’s-test were used for independent variables and the Wilcoxon test was used for dependent variables. Results In total, 143 patients were included in the initial evaluation (group 1: 38; group 2: 105). Nineteen comparable pairings could be formed (mean initial IL-6: 58,385 vs. 59,812 pg/ml; mean SAPS II: 77 vs. 75). There was a significant reduction in IL-6 in patients with (p < 0.001) and without CS treatment (p = 0.005). However, there was no significant difference (p = 0.708) in the median relative reduction in both groups (89% vs. 80%). Furthermore, there was no significant difference in the relative change in C-reactive protein, lactate, or norepinephrine demand in either group and the in-hospital mortality was similar between groups (73.7%). Conclusion Our study showed no difference in IL-6 reduction, hemodynamic stabilization, or mortality in patients with Cytosorb® treatment compared to a matched patient population.


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