The Safety and Efficacy of Transarterial Chemoembolization with Bleomycin for Hepatocellular Carcinoma Unresponsive to Doxorubicin:A Prospective Single-center Study

2020 ◽  
Author(s):  
jinxin fu ◽  
yan wang ◽  
jinlong zhang ◽  
kai yuan ◽  
jieyu yan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Transarterial Chemoembolization ◽  
Controlled Trial ◽  
Objective Response ◽  
Progression Free Survival ◽  
Control Group ◽  
Safety And Efficacy ◽  
Post Procedure ◽  
Significant Difference ◽  
Experimental Group

Abstract Purpose To investigate the safety and efficacy of transarterial chemoembolization (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin.Methods We did a randomized controlled trial in HCC patients resistant to TACE with doxorubicin to assess the survival benefits of the experimental group (TACE with bleomycin) compared with the control group (TACE with doxorubicin). 170 patients were allocated randomly between December 2015 and December 2017 and 80 patients of each group were accomplished and analyzed finally. The modified response evaluation criteria in solid tumors (mRECIST) was used to evaluated the tumor response every 4-6 weeks. The primary endpoint was median progression-free survival (mPFS) and median overall survival (mOS). Safety was assessed by post-procedure complications.Results The study was stopped in October 2018. Objective response rate (ORR) of the experimental group was 27.5% (22/80) , mPFS and mOS was 5.8 and 8.1 months. ORR of the control group was 7.5% (6/80) , mPFS and mOS was 2.9 and 4.0 months. The ORR were significantly different between two grous ( χ²= 0.348, P＜0.05). The differences of mPFS and mOS between the two groups were statistically significant (χ² = 2.865, P＜0.05 and χ² = 0.926, P＜0.05, respectively). There were no significant difference in post-procedure complications (P＞0.05) and no major complications occurred.Conclusion It is suggested that TACE with bleomycin is a safe and effective method for HCC and bleomycin can be a second-line chemotherapeutic agent for the HCC patients unresponsive to TACE with doxorubicin.

scholarly journals Transarterial Chemoembolization Combined with Iodine 125 Seeds Versus Transarterial Chemoembolization Combined with Radiofrequency Ablation in the Treatment of Early and Intermediate Hepatocellular Carcinoma

2020 ◽  
Author(s):  
chen lei ◽  
Xuefeng Kan ◽  
Tao Sun ◽  
Yanqiao Ren ◽  
Yanyan Cao ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiofrequency Ablation ◽  
Transarterial Chemoembolization ◽  
Objective Response ◽  
Progression Free Survival ◽  
Free Survival ◽  
Risk Of Death ◽  
Significant Difference ◽  
Pugh Class ◽  
Iodine 125

Abstract Background To compare the efficacy of the combination of transarterial chemoembolization (TACE) and iodine 125 seeds implantation (TACE-Iodine 125) with the combination of TACE and radiofrequency ablation (RFA) in the treatment of patients with early and intermediate hepatocellular carcinoma (HCC). Methods The study included 134 patients diagnosed with early and intermediate HCC from January 1, 2014, to May 31, 2018. Among them, 47 patients were treated with TACE-Iodine 125, and 87 with TACE-RFA and the efficacy of both treatments was analyzed. To reduced selective bias, propensity score matching (PSM) was used to compare the outcomes of the treatments. Results In the absence of PSM, the median overall survival (OS) and progression-free survival (PFS) of the TACE-RFA group were slightly longer than those of the TACE-Iodine 125 group (OS: 42 months vs. 37 months; PFS: 18 months vs. 15 months). However, there was no significant difference in median OS, PFS, and the objective response rate (ORR) between the two groups (P>0.05). After adjusted for age, gender, liver resection, Child-Pugh class, Barcelona Clinic Liver Cancer (BCLC) stage and Alpha-fetoprotein (AFP), TACE-Iodine 125 treatment was not associated with a significant increasing in risk of death (HR: 0.725; 95%CI: 0.423,1.241, P=0.241) and recurrence (HR: 1.008; 95%CI: 0.666,1.526, P=0.969). After PSM, 47 patient pairs were generated, and there was no significant difference in median OS and PFS between the two groups. Conclusions The combination of TACE and iodine 125 seeds implantation may represent an effective treatment for patients with early and intermediate HCC.

Does soft tissue mobilization assist static stretching to improve hamstring flexibility? A randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Shibili Nuhmani
Keyword(s):  
Soft Tissue ◽  
Controlled Trial ◽  
Knee Extension ◽  
Repeated Measure ◽  
Control Group ◽  
Static Stretching ◽  
Significant Difference ◽  
Hamstring Flexibility ◽  
Soft Tissue Mobilization ◽  
Experimental Group

AbstractObjectivesObjective of the study is to investigate whether Soft tissue mobilization (STM) can assist with static stretching to improve hamstring flexibly.MethodsThe design of the study was repeated measure design. The study was conducted at the physical therapy laboratory of Jamia Hamdard University, New Delhi. Participants included 78 healthy males with hamstring tightness, randomly assigned to either the control group (static stretching) or the experimental group (STM and static stretching). The experimental group received five sets of four different STM techniques, followed by two sets of 30-s static stretches 3 days per week over the course of 12 weeks. The control group received 5 min of sham ultrasound with an inactive probe prior to static stretching. Active knee extension test (AKE) was the outcome measure.ResultsBoth groups showed significant improvement in AKE compared with the baseline measurements. With ingroup analysis showed a significant difference in AKE across all measured time periods (weeks 4, 8, and 12) with pre-test in both groups (p<0.05). No significant difference in AKE improvement was found between groups (p>0.05).ConclusionThe results of this study show that STM prior to static stretching does not significantly improve hamstring flexibility among healthy individuals. Although this study cannot be generalized, the results may be useful for evidence-based practice in the management of hamstring tightness.

Efficacy of gefitinib combined with bevacizumab versus gefitinib in advanced EGFR L858R NSCLC.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21185-e21185
Author(s):  
Xinmin Zhao ◽  
Xianghua Wu ◽  
Huijie Wang ◽  
Hui Yu ◽  
Si Sun ◽  
...  
Keyword(s):  
Liquid Biopsy ◽  
Therapeutic Option ◽  
Objective Response ◽  
Acquired Resistance ◽  
Response To Treatment ◽  
Control Group ◽  
Special Cases ◽  
Significant Difference ◽  
Experimental Group ◽  
Egfr Tkis

e21185 Background: 60-80% of EGFR+ NSCLC could benefit from the treatment of EGFR TKIs. However, as a result of acquired resistance, median progression-free survival (PFS) associated with EGFR-TKIs monotherapy was rarely longer than 11 months. Vascular endothelial growth factor (VEGF) and its receptor (VEGFR) play an important role in the angiogenesis and progression of NSCLC. The combination of EGFR-TKIs and anti-vascular drugs that inhibit the EGFR and VEGF/VEGFR pathways may be a potential therapeutic option for EGFR-mutant NSCLC. The purpose of our study was to evaluate whether gefitinib combined with bevacizumab is associated with an increased PFS benefit compared with gefitinib alone. Methods: This study is a randomized, open-controlled, single-center study. A total of 43 advanced non-squamous NSCLC patients with EGFR L858R mutations were enrolled, including 24 in the experimental group and 19 in the control group. The experimental group received gefitinib combined with bevacizumab (gefitinib 250 mg, QD+bevacizumab 7.5 mg/kg, Q3W), and the control group received gefitinib monotherapy (250 mg, QD). Response to treatment was evaluated after one month of the treatment, followed by once every two months, and adverse events were graded. The primary endpoint was PFS, and secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety and tolerability evaluation. Samples at baseline (tissue or liquid biopsy), 43 days after treatment (liquid biopsy), and disease progression were subjected to genomic (139-gene NGS panel) profiling. Results: As of December 31, 2020, 22 patients were evaluable (12 for experimental group, 10 for control group). The ORR of the experimental group and the control group were 42% vs 60%, respectively, with no significant difference (experimental group: CR = 0, PR = 5, SD = 7, PD = 0; control group: CR = 0, PR = 6, SD = 4, PD = 0). Main adverse reactions included skin rash (n = 16), diarrhea (n = 24), hypertension (n = 2), proteinuria (n = 1). Other special cases developed fever, nausea and vomiting, elevated platelets, conjunctivitis, back pain, which were manageable. 36 patients with baseline liquid biopsy samples can be evaluated (33 plasma and 3 pleural fluid samples). Of these, EGFR L858R were detectable in 86% (n = 31) of patients. The most common co-mutated gene was TP53 (57%), followed by DNMT3A (49%) and TET2 (17%). Mutation profiles were comparable between the two groups. Conclusions: Compared to gefitinib monotherapy, gefitinib combined with bevacizumab in the treatment of non-squamous NSCLC with EGFR L858R showed similar efficacy and safety profiles.

scholarly journals Transarterial Chemoembolization Combined With Radiofrequency Ablation Versus Repeat Hepatectomy for Recurrent Hepatocellular Carcinoma After Curative Resection: A 10-Year Single-Center Comparative Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Xin Zheng ◽  
Yanqiao Ren ◽  
Hanqing Hu ◽  
Kun Qian
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiofrequency Ablation ◽  
Transarterial Chemoembolization ◽  
Curative Resection ◽  
Progression Free Survival ◽  
Repeat Hepatectomy ◽  
Tumor Diameter ◽  
Recurrent Hepatocellular Carcinoma ◽  
Significant Difference ◽  
Hepatectomy Group

BackgroundThe purpose of this study was to compare the efficacy and safety of transarterial chemoembolization (TACE) in combination with radiofrequency ablation (RFA) (TACE-RFA) and repeat hepatectomy in the treatment of recurrent hepatocellular carcinoma (HCC) after curative resection.MethodsThis retrospective study evaluated consecutive medical records of patients who received either TACE-RFA or repeat hepatectomy between January 2010 and May 2021. Overall survival (OS), progression-free survival (PFS), and complications were compared.ResultsOf the 2672 patients who received either TACE-RFA or repeat hepatectomy, 111 eligible patients were included in our study, 63 in the TACE-RFA group and 48 in the repeat hepatectomy group. The median OS was 38 months in the TACE-RFA group and 42 months in the repeat hepatectomy group, with no statistically difference between the two groups (P=0.45). Meanwhile, there was also no statistically significant difference in PFS between the two groups (P=0.634). Although both groups achieved similar outcomes, the rate of major complications was significantly higher in the repeat hepatectomy group (P=0.003).ConclusionsPatients with recurrent HCC in the TACE-RFA group and the repeat hepatectomy group had similar OS and PFS regardless of the patient’s tumor diameter, but the TACE-RFA group was safer and more minimally invasive.

scholarly journals Effectiveness Of Topical Application Of Chlorhexidine And Prevailing Practices On Episiotomy Wound Among Postnatal Mothers

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Rincy Michael ◽  
Soney N Toppo ◽  
Varsha Hariharan
Keyword(s):  
Wound Healing ◽  
Topical Application ◽  
Controlled Trial ◽  
Demographic Data ◽  
Assessment Scale ◽  
Research Centre ◽  
Control Group ◽  
Significant Difference ◽  
Postnatal Mothers ◽  
Experimental Group

Puerperium is a period when the mother experiences intense physical and emotional stress due to exhaustion, anxiety and excitement. Each mother has to adjust to physical changes in her own body due to involution and lactation as well as cope up with the new demands on her time and emotions made by the new born baby. Episiotomy, despite evidences that it is an unnecessary intervention, is one of the most common surgical procedures performed during the second stage of labour, especially in primigravida woman. Thus, a randomized controlled trial to assess the effectiveness of topical application of chlorhexidine and prevailing practices on episiotomy wound among postnatal mothers at selected hospital of Indore was undertaken. True experimental approach with pre test post test research design was adopted. Simple random sampling was taken to select 40 postnatal mothers with episiotomy wound and three days postpartum hospital stay in Choithram Hospital & Research Centre, Indore as per the inclusion criteria. Data was collected with help of questionnaire for socio demographic data and obstetrical data and the wound healing was assessed by REEDA wound healing assessment scale. Samples in the experimental group were applied with chlorhexidine on episiotomy wound and the samples in the control group received routine care with betadine or nadoxin. Post assessment score was taken on third day (evening) by REEDA wound assessment scale. Finding of the study related to effectiveness of chlorhexidine among postnatal mothers in experimental group revealed that there was a significant difference in the healing of episiotomy wound by the application of chlorhexidine among postnatal mothers in experimental group at t19 = 11.40 at the level of p< 0.001. Hence it was inferred that topical application of chlorhexidine on episiotomy wound promotes wound healing.

Safety, tolerability and efficacy of transarterial chemoembolization using anthracyclines-loaded drug eluting microspheres for treatment of patients with unresectable hepatocellular carcinoma: Pooled analyses.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 287-287
Author(s):  
Thierry De Baere ◽  
Filipe Veloso Gomes ◽  
Gontran Verset ◽  
Gerardo Tovar-Felice ◽  
Katerina Malagari ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Function ◽  
Transarterial Chemoembolization ◽  
Tumor Response ◽  
Objective Response ◽  
Progression Free Survival ◽  
Close Monitoring ◽  
Bridge To Transplant ◽  
Level Data ◽  
Drug Eluting

287 Background: Transarterial chemoembolization either with Lipiodol (cTACE) or with drug eluting microspheres (DEM-TACE) is indicated for the treatment of hepatocellular carcinoma (HCC) not amenable to curative treatments in patients with preserved liver function. Safety of TACE is becoming more important with its increased use as a bridge to transplant or downstaging to resection, but also for preservation of liver function in case of subsequent immuno-combination therapies. LifePearl microspheres is a novel DEM comprised of polyethylene-glycol with reported good safety profile and efficacy in smaller series. Our purpose was to assess safety and efficacy of TACE using anthracycline loaded LifePearl for the treatment of patients with unresectable HCC in a pooled analysis of studies with available more than 500 patient’s level data. Methods: We pooled patient level data from 5 single arm studies. Safety was assessed by close monitoring of adverse events according to CTCAE (v4.03). Tumor response was assessed, according to mRECIST and RECIST1.1 and analyzed as best overall response to account for differences in time of imaging follow-up between studies. The Kaplan-Meier method was used to estimate event rates for time to event outcomes: progression free survival (PFS), time to unTACEable progression (TTUP) and overall survival (OS) censoring patients at time of surgery or transplantation. Results: Out of 586 patients, 85.5%, 13.5% and 1.0% were Child Pugh A, B and C, respectively. BCLC stages 0, A, B and C were 13.6%, 43.4%, 41.1% and 1.9% respectively. The mean number of HCC lesions was 2.1±1.5 and mean sum of tumor diameters was 49.3±32.9mm. In 19% of patients alpha-feto protein level was > 200ng/ml. A mean of 1.9±1.3 DEM-TACEs were performed per patient. A total of 197 events were reported including 2.6 % grade 4 and 1.5% grade 5, mostly related to post-embolization syndrome. Complete response, partial response and stable disease were 60.2%, 27.1% and 7.4% respectively providing an objective response and disease control rates of 87,3% and 94,7% respectively. 10% of patients were transplanted or resected. Median OS, PFS and TTUP is indicated in the table below. OS was 89.2%, 80.2% and 69.7% at 12, 18 and 24 months respectively. Conclusions: The treatment of patients with unresectable HCC with anthracycline loaded LifePearl showed good tolerance with acceptable toxicity and high tumor response rate that translated into promising PFS, TTUP and OS. [Table: see text]

scholarly journals Ganji Formulation for Patients with Hepatocellular Carcinoma Who Have Undergone Surgery: A Multicenter, Randomized, Double-Blind, Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Jing-Hao Zhang ◽  
Chao Zheng ◽  
Xiao-Jun Zhu ◽  
Xin Zhang ◽  
Zhi-Jun Hou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Treatment Group ◽  
Liver Resection ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Control Group ◽  
Double Blind ◽  
Local Ablation ◽  
Significant Difference ◽  
And Control

Objective. To ascertain the efficacy and safety of Ganji Formulation (GF) for patients with Hepatocellular carcinoma (HCC) who had undergone surgery. Materials and Methods. A total of 262 HCC patients who had undergone liver resection, local ablation, or transcatheter arterial chemoembolization (TACE) were divided randomly into the treatment group and control group. The former was treated with GF and the later with placebo, both for 6 months. The primary endpoint was overall survival (OS). Second endpoints were disease-free survival (DFS) or time to disease progression (TTP). Results. OS of the treatment group was significantly longer than that of the control group (P < 0.05). Subgroup analysis showed that, for patients who received TACE, the TTP was significantly longer in the treatment group than in the control group (P < 0.05). However, for patients who underwent liver resection or local ablation, there was no significant difference in DFS between the two groups (P > 0.05). Conclusion. GF could improve postoperative cumulative survival and prolong the TTP. This clinical trial number is registered with ChiCTR-IOR-15007349.

Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

2007 ◽  
Vol 25 (21) ◽  
pp. 3069-3075 ◽  
Author(s):  
Robert G. Gish ◽  
Camillo Porta ◽  
Lucian Lazar ◽  
Paul Ruff ◽  
Ronald Feld ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Karnofsky Performance Status ◽  
Controlled Trial ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Study Objective

PurposeThe study objective was to compare the overall survival (OS) of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with nolatrexed (NOL) or doxorubicin (DOX).Patients and MethodsPatients from North America, Europe, and South Africa (N = 445) with HCC were randomly assigned to receive NOL or DOX. Eligible patients had Karnofsky performance status (KPS) ≥ 60%, Cancer of the Liver Italian Program (CLIP) score ≤ 3, and adequate organ function. Primary end point was OS. Secondary end points included progression-free survival (PFS), objective response rates, and safety. The treatment groups were well-balanced with regards to age, sex, ethnic origin, and underlying liver disease. Randomization was stratified according to KPS and CLIP score.ResultsAt the time of the final analysis, 377 patients had died. Median OS was 22.3 weeks for NOL and 32.3 weeks for DOX (P = .0068). The hazard ratio was 0.753 in favor of DOX. Objective response rate (complete response [CR] plus partial response [PR]) was 1.4% for NOL and 4.0% for DOX. Median PFS was 12 weeks for NOL and 10 weeks for DOX (P = .7091). Median time to treatment failure was 8.4 weeks for NOL and 9.1 weeks for DOX (P = .0969). Grade 3 and 4 stomatitis, vomiting, diarrhea, and thrombocytopenia were more common in the NOL arm. Alopecia was more common in the DOX arm. More patients were withdrawn from study for toxicity in the NOL arm than in the DOX arm.ConclusionNOL showed minimal activity in this phase III trial. Further exploration at this dose and schedule in HCC is not warranted.

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

scholarly journals Effectiveness of yoga on anxiety, depression and stress level of breast cancer patients undergoing chemotherapy

2017 ◽  
Vol 6 (1) ◽  
pp. 74
Author(s):  
Kamli Prakash ◽  
Sunil Saini
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Stress Level ◽  
Controlled Trial ◽  
Control Group ◽  
Research Approach ◽  
Breast Cancer Patients ◽  
Significant Difference ◽  
Anxiety Depression ◽  
Experimental Group

Background: Breast cancer has ranked number one cancer among Indian females. Women undergoing chemotherapy experience many side effects including alteration in their body image. The present study assessed effectiveness of yoga on anxiety, depression and stress level of breast cancer patients undergoing chemotherapy.Methods: Quantitative Research approach and Randomized Clinical Controlled Trial with Time series design was adopted in the present study. The consecutive sampling technique was done to recruit 100 breast cancer patients fulfilling the eligibility criteria. Recruited patients were randomized to control (N=52) and experiment (N=48) groups by concealed randomization. Written informed consent was taken from each participant. Baseline data was collected during cycle one by using Anxiety depression and stress scale. The patients in the experimental group were taught Diaphragmatic breathing, systematic relaxation and alternate nostril breathing and Joints and Gland neck and shoulder exercises, and were instructed to practice them twice daily at home. They were supervised in practicing these when they received second, third, fourth, fifth and sixth cycles of chemotherapy. Participants in control group received routine care. Data was again collected after 21 days during second, third, fourth, fifth and sixth cycles of chemotherapy.Results: Analysis revealed that at the baseline breast cancer patients in control and experimental group were homogenous in terms of their Sociodemographic and anxiety depression and stress scores. After the yoga intervention the experimental group showed statistically significant difference in anxiety scores from control group during second, third and sixth cycles (p 0.01, p 0.02, p 0.02), in depression score during the second, third, fourth, fifth and sixth cycles (p 0.02, p 0.02, p 0.02, p 0.001, p 0.000), and in stress scores during third cycle (p 0.01) of chemotherapy.Conclusions: On the basis of findings of the study it was concluded that yoga was effective in reducing the anxiety, depression and stress of breast cancer patients undergoing chemotherapy. Therefore, it is recommended as complementary therapy for patients receiving treatment for cancer. 

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