Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: A randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15002-e15002
Author(s):  
Rong-xin Zhang ◽  
Jun-zhong Lin ◽  
Gong Chen ◽  
Li-ren LI ◽  
Zhen-hai LU ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Surgical Resection ◽  
Control Group ◽  
Control Groups ◽  
Safety And Efficacy ◽  
Colorectal Cancer Patients ◽  
And Control ◽  
Intraoperative Chemotherapy

e15002 Background: The safety and efficacy of intraoperative chemotherapy in colorectal cancer have not yet been extensively investigated. This randomized control trial was designed to compare the safety and efficacy of intraoperative chemotherapy in combination with surgical resection to those of traditional surgical resection alone. Patients and Methods: From January 2011 to January 2016, 696 colorectal cancer patients were enrolled in this study: 341 patients were randomly assigned to the intraoperative plus surgery group to receive intraoperative chemotherapy (portal vein, intraluminal, and intraperitoneal chemotherapy plus surgical resection), whereas 344 patients were randomized to the control group to undergo surgery alone. Eleven patients withdrew consent. Surgical complications and side effects of intraoperative chemotherapy were compared between the two groups. Results: Intraoperative chemotherapy did not increase the rate of surgical complications, and no severe chemotherapy-associated side effects were observed. There were no significant differences in the length of hospital stay (8.31 vs. 7.98 days, P = 0.138), length of surgery (170.4 vs. 167.0 min, P = 0.526), length of antibiotic use (2.28 vs. 2.15 days, P = 0.322), or length of drain usage (6.37 vs. 6.16 days, P = 0.387) between the intraoperative chemotherapy and control groups. Four patients in each of the intraoperative chemotherapy and the control groups experienced anastomotic leakage and underwent a second operation (1.2% vs. 1.2%, P = 0.99). There were no deaths within 90 days after surgery in the chemotherapy group, whereas one patient died in the control group (0% vs. 0.3%, P = 0.99). Intraoperative chemotherapy did not decrease the rate of patients who received postoperative adjuvant chemotherapy between the intraoperative group and control group (29.3% vs. 30.2%, P = 0.795). Conclusions: Intraoperative chemotherapy can be safely performed during colorectal surgery; however, follow-up is necessary for a better assessment of its efficacy. Register Number: NCT01465451. Clinical trial information: NCT01465451.

scholarly journals Safety and efficacy study: Short-term application of radiofrequency ablation and stereotactic body radiotherapy for Barcelona Clinical Liver Cancer stage 0–B1 hepatocellular carcinoma

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245076
Author(s):  
Feiqian Wang ◽  
Kazushi Numata ◽  
Atsuya Takeda ◽  
Katsuaki Ogushi ◽  
Hiroyuki Fukuda ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiofrequency Ablation ◽  
Side Effects ◽  
Liver Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Control Group ◽  
Control Groups ◽  
Short Term ◽  
Safety And Efficacy ◽  
And Control

Aim To evaluate the safety and efficacy of the administration of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the short term to the same patients in Barcelona Clinical Liver Cancer (BCLC) stages 0–B1. Methods From April 2014 to June 2019, we retrospectively reviewed BCLC stage 0–B1 patients with fresh hepatocellular carcinoma (HCC) lesions that were repeatedly treated by RFA (control group, n = 72), and by RFA and subsequent SBRT (case group, n = 26). Propensity score matching (PSM) was performed to reduce the selection bias between two groups. Recurrence, survival, Child–Pugh scores and short-term side effects (fever, bleeding, skin change, abdominal pain and fatigue) were recorded and analyzed. Results After PSM, 21 patients remained in each group. Seventeen and 20 patients in the case and control groups experienced recurrence. For these patients, the median times to progression and follow-up were 10.7 and 35.8 months, respectively. After PSM, the 1-year progression-free survival rate in case and control groups were 66.7% and 52.4%, respectively (P = 0.313). The inter-group overall survival (OS) was comparable (3 and 5-year OS rates in case groups were 87.3% and 74.8%, while rates in control groups were 73.7% and 46.3%, respectively; P = 0.090). The short-term side effects were mild, and the incidence showed no inter-group difference. The 1-year rates of the Child–Pugh score deterioration of ≥2 in case and control groups were 23.8% and 33.3% (P > 0.05), respectively. Conclusion The short-term administration of RFA and SBRT to the same BCLC stage 0–B1 patients may be feasible and effective because of their good prognosis and safety.

scholarly journals Adamalysines as Biomarkers and a Potential Target of Therapy in Colorectal Cancer Patients: Preliminary Results

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Katarzyna Walkiewicz ◽  
Joanna Strzelczyk ◽  
Dariusz Waniczek ◽  
Krzysztof Biernacki ◽  
Małgorzata Muc-Wierzgoń ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Distant Metastases ◽  
Serum Levels ◽  
Control Group ◽  
Colorectal Cancer Patients ◽  
And Control ◽  
The Relationship ◽  
Increased Activity

Colorectal cancer is one of the most common cancers in the world. Due to its still undetermined pathogenesis, we are searching for signaling pathways that are important in the development of colorectal cancer. In this article, we present results of study on the role of ADAM proteins in colorectal cancer. The study included 85 adult colorectal cancer patients (48 men, 37 women) and 25 patients in the control group (after diagnostic colonoscopy—without cancer). During hospitalization, a serum sample (3 cm3) was collected from the study and control group, anthropometric measurements were conducted and others clinical data were analyzed. In the serum ADAM10, 12, 17, and 28, protein concentrations were determined and, in the next step, examined the relationship between ADAMs concentrations and selected clinical parameters in both groups. The analysis showed that serum levels of ADAM10 and ADAM28 are significantly higher in patients with colorectal cancer and correlate with histopathological grading and with presence of distant metastases. Moreover, noticed the trend to correlate concentrations of adamalysines with higher BMI score. One of the functions of adamalysines is the activation of growth factors involved in cancer, including IGF and TNFα. The increased activity of adamalysines in patients may play a role in the pathogenesis of colorectal cancer. Our study highlights the prevalence of metabolic disorders in the group of patients with diagnosed CRC, and this cancer seems to be a further complication of obesity.

scholarly journals Health services research in colorectal cancer: a quasi-experimental interventional pilot study on in- and outpatient oncology

2020 ◽  
Author(s):  
Margarete Reiter ◽  
Michael Gerken ◽  
Patricia Lindberg-Scharf ◽  
Alois Fuerst ◽  
Gudrun Liebig-Hörl ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Intervention Group ◽  
Control Group ◽  
Nutritional Counseling ◽  
Oncology Nurse ◽  
Gastrointestinal Side Effects ◽  
Colorectal Cancer Patients ◽  
Outpatient Counseling

Abstract Introduction Due to frequent treatment side effects and weight loss, colorectal cancer patients require oncologic care and nutritional counseling both during and after hospitalization. The current study evaluated differences in discharge and side effects management and nutritional behavior between colorectal cancer patients of a control group without systematic counseling and of an intervention group with access to structured in- and outpatient oncology nurse and nutritional counseling. Methods The presented explorative, quantitative, single-center, interventional pilot study is a health services research project with a quasi-experimental design. Using a self-designed standardized questionnaire, data were collected from the control group (n = 75) before and from the intervention group (n = 114) after the introduction of in- and outpatient oncology nurse and structured systematic nutritional counseling. The in- and outpatient counseling services were developed and evaluated in the form of a structured nurse-led counseling concept. Results Intervention group patients profited significantly from inpatient oncology nurse counseling in seven different areas of discharge management. No differences were observed concerning patient-reported general and gastrointestinal side effects except for xerostomia and dysphagia, but of the patients participating in both in- and outpatient oncology nurse counseling, 90.0% were better able to cope with general side effects of treatment. Patients with in- and outpatient structured systematic nutritional counseling more frequently received nutritional information (p = 0.001), were better at gauging food intolerances (p = 0.023), and followed the dietician's advice in cases of gastrointestinal side effects significantly more often (p = 0.003) than control patients. Counselor-reported outcomes concerning gastrointestinal side effects showed improvement in most of the patients taking part in systematic in- and outpatient nutritional counseling, except for weight loss in 4 patients. Conclusion In- and outpatient counseling in discharge and side effects management and nutrition improve the outcomes of colorectal cancer patients. Outpatient counseling should be further developed and evaluated in future studies.

Effects of Virgin Coconut Oil as Adjunct Therapy in the Treatment of Allergic Rhinitis

2016 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Nazli Zainuddin ◽  
Nurul Azira Mohd Shah ◽  
Rosdan Salim
Keyword(s):  
Allergic Rhinitis ◽  
Side Effects ◽  
Coconut Oil ◽  
Test Group ◽  
Nasal Symptom ◽  
Control Group ◽  
Virgin Coconut Oil ◽  
Control Groups ◽  
Significant Difference ◽  
And Control

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.

Novel CoupledCAR technology for treating colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2528-2528
Author(s):  
Lei Xiao ◽  
Song Li ◽  
Chengfei Pu ◽  
Zhiyuan Cao ◽  
Xinyi Yang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
T Cells ◽  
Complete Remission ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Tumor Tissue ◽  
Lentiviral Vectors ◽  
Safety And Efficacy ◽  
Pet Ct ◽  
Colorectal Cancer Patients

2528 Background: Chimeric antigen receptor (CAR) T cell therapy has made significant progress in the treatment of blood cancers such as leukemia, lymphoma, and myeloma. However, the therapy faces many challenges in treating solid tumors. These challenges include physical barriers, tumor microenvironment immunosuppression, tumor heterogeneity, target specificity, and limited expansion in vivo. Methods: We designed a CAR lentivirus vector that consisted of a humanized CD19-specific single-chain variable fragment (scFv), a 4-1BB costimulatory domain, and a CD3ζ signaling domain.The lentivirus was produced by transfecting HEK-293T cells with CAR lentiviral vectors and viral packaging plasmids. Patient’s CD3 T cells was cultured in X-VIVO medium containing 125U/mL 1interleukin-2 (IL-2), and transduced with CAR lentivirus at certain MOI 24h after stimulated by anti-CD3/CD28 magnetic beads. Transduction efficiency was evaluated at 7 to 9 days after CAR lentivirus transduction, and quality controls for fungi, bacteria, mycoplasma, chlamydia, and endotoxin were performed. After infusion, serial peripheral blood samples were collected, and the expansion and the cytokine release of CART cells were detected by FACS and QPCR,respectively. The evaluation of response level for patients were performed at month 1,month 3,and month 6 by PET/CT. Results: We engineered CoupledCAR T cells with lentiviral vectors encoding an anti-GCC (guanylate cyclase 2C) CAR molecule. To verify the safety and efficacy of CoupledCAR-T cells for treating solid tumors, we conducted several clinical trials for different solid tumors, including seven patients with colorectal cancer. These seven patients failed multiple rounds of chemotherapy and radiotherapy. In the clinical trial, the metastatic colorectal cancer patients were infused with autologous anti-GCC CoupledCAR-T cells range from 4.9×105/kg to 2.9×106/kg. We observed that CoupledCAR-T cells expanded significantly in the patients and infiltrated tumor tissue sites, demonstrating enhanced anti-tumor activities. PET/CT showed significant tumor shrinkage and SUV max declined, and the ongoing responses were monitored. Patient 3 achieved complete response and the best overall response rate (ORR, include complete remission, complete metabolic response, and partial response.) was 57.1% (4/7), complete remission (CR) rate was 14.3% (1/7). Conclusions: In conclusion, the clinical data demonstrated that CoupledCAR-T cells effectively expanded, infiltrated tumor tissue sites, and kill tumor cells in patients with colorectal cancer. We used immunotherapy to achieve complete remission in patients with advanced colorectal cancer for the first time. We are recruiting more colorectal cancer patients to further test the safety and efficacy of anti-GCC CoupledCAR T cells. Since our CoupledCAR technology is a platform technology, we are expanding it to treat other solid tumors using different target tumor markers.

THE APPLICATION OF STATISTICAL METHODS IN EVALUATING THE RESULTS OF CLINICAL FINDINGS OF THE DRUG BOVHUALONIDASE AZOXIMER IN CATS WITH UROLOGICAL DISEASES

2020 ◽  
pp. 212-218
Author(s):  
А. V. Nazarova ◽  
◽  
B. S. Semenov ◽  
Т. Sh. Kuznetsova ◽  
◽  
...  
Keyword(s):  
Relative Risk ◽  
Side Effects ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Control Group ◽  
Control Groups ◽  
Saint Petersburg ◽  
Number Of Patients ◽  
And Control ◽  
Experimental Group

In the period from November 2018 to August 2020, we conducted a randomized blind placebo-controlled confirmatory clinical trial in parallel groups on the basis of network of veterinary clinics in Saint Petersburg and Saint Petersburg state university of veterinary medicine. The purpose of the study: to evaluate the effectiveness of Bovhualonidaze azoximer(BA) in patients subjected to surgical intervention on the urethra and bladder, to prevent postoperative complications and relapses of the underlying disease. The frequency of complications was taken as an indicator of effectiveness. 80 cats were evaluated according to the criteria for inclusion in the study, after evaluation and randomization, 53 patients (24 and 29 cats in the experimental and control groups, respectively) who had indications for surgery on the urethra and/or bladder were included in the study. After the withdrawal of some patients, 38 cats were analyzed (17 and 23 cats in the experimental and control groups, respectively). Animals in the experimental group received BA drugs in addition to conventional therapy, and animals in the control group received placebo. The rate of complications in the experimental group was 11.8 %, in the control group-61.9 %. The relative risk was 19.0 %, and the relative risk reduction was 80.9 %. The chance of developing complications in the animals of the experimental group is 12.2 times lower than in animals of the control group.. Absolute risk reduction — 50.1 %, and the number of patients to be treated — 2 patients. The confidence interval for the risk of side effects of BA drugs in cats was 0.0-10.1 %. Based on the results of our clinical study, we proved that the use of BA drugs is effective for preventing complications during surgical interventions on the urethra and bladder, and the risk of side effects when using BA drugs in cats is insignificant

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