Retrospective observational study of sunitinib administered on schedule 2/1 in patients with metastatic renal cell carcinoma (mRCC): The rainbow study.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 471-471 ◽  
Author(s):  
Sergio Bracarda ◽  
Roberto Iacovelli ◽  
Mimma Rizzo ◽  
Marta Rossi ◽  
Luca Galli ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Clear Cell ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Initial Therapy ◽  
Control Group ◽  
Group A ◽  
Grade 3 ◽  
Group B ◽  
Clinical Conditions

471 Background: Sunitinib is a standard of care in first line mRCC; however, an increasing percentage of treatment-related adverse events are observed in the last 2 treatment weeks of the standard schedule 4/2 (4-weeks-on/2-weeks-off). In a multicenter, retrospective study, we evaluated the efficacy and safety of a modified 2/1 schedule (2-weeks-on/1-week-off), largely used in Italy based on a favorable initial experience. Methods: Data from all consecutive patients (pts) treated in 24 Italian centers with sunitinib on schedule 2/1 were analyzed according to the following groups: Group A, pts moved to schedule 2/1 because of treatment-related toxicities during initial therapy using schedule 4/2; Group B, pts treated ab initio with schedule 2/1, mainly because of poorer clinical conditions. A small group of pts treated with schedule 4/2 served as a control (Group C). Results: 276 consecutive pts treated from November 2005 to August 2013 were analyzed, including 249 treated with schedule 2/1 (Group A, n=208; Group B, n=41; respectively, median age 62 and 61 years; clear cell 94.7% and 87.8%; MSKCC good/intermediate/poor 47.1%/46.6%/6.3% and 36.5%/53.7%/9.8%; brain metastases 3.8% and 9.8%) and 27 pts in Group C (median age 59 years; clear cell 96.3%; MSKCC good/intermediate/poor 22.2%/70.4%/7.4%; no brain metastases). In Group A, the median treatment duration (TD) was 28.2 months (m) (with a median of 4.3 on the initial schedule 4/2 and 19.7 on the following schedule 2/1); median progression-free survival (PFS) was 38.6 m (95% CI, 24.0-58.6). In Group B (with less clear cell cases and more pts of intermediate risk or with brain metastases) median TD was 7.8 m and median PFS was 9.6 m (95% CI, 6.3-14.2). Median TD in Group C was 10.4 m. Maximum toxicity grade (≥3) and specific toxicities such as fatigue and hypertension were significantly reduced on schedule 2/1 in Group A compared with the initial schedule 4/2 (respectively, 8% vs 46% and 0% vs 10%, p < .001, and 2% vs 9%, p = .007). Conclusions: In our experience, sunitinib on a modified schedule 2/1 has an improved safety profile and increased efficacy compared with schedule 4/2. Prospective evaluation of this schedule is warranted.

Paclitaxel/gemcitabine versus paclitaxel/vinorelbine in advanced non-small cell lung cancer (NSCLC): A phase III randomized study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8038-8038
Author(s):  
P. A. Kosmidis ◽  
E. Timotheadou ◽  
A. Koutras ◽  
G. Pentheroudakis ◽  
C. Christodoulou ◽  
...  
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Disease Characteristics ◽  
Group A ◽  
Severe Infections ◽  
Grade 3 ◽  
Intent To Treat ◽  
Group B

8038 Background: Paclitaxel and vinorelbine (PV) have shown synergism of cytotoxic effect in vitro (Cancer Invert, 2000, 18(8): 804-5). This combination was compared prospectively to the paclitaxel/gemcitabine (PG) regimen in non-operable NSCLC. Methods: 415 stage IIIb wet and IV chemotherapy-naïve for metastatic disease patients with PS 0–1 were randomized to paclitaxel 200mg/m2 on day 1 plus either gemcitabine 1gm/m2 (Group A) or vinorelbine 25mg/m2 (Group B) on days 1 and 8 every 3 wks as first line chemotherapy. Results: A total of 398 out of 415 patients were eligible for analysis on the intent to treat basis (group A: 196, group B: 202). All patient and disease characteristics were well balanced. Overall response rate (RR) was 27% for group A and 24% for group B (P=0.57). Median progression free survival (PFS) was 5.2 months (m) (95% CI, 4.4 - 5.9) and 4.7m (95% CI, 4.1 - 5.3) for groups A and B respectively (P=0.51). Median survival (OS) was 11.5m (95% CI, 9.5 - 12.6) and 9.3m (95% CI, 7.7 - 10.9) for groups A and B respectively (P=0.25). Grade 3/4 neutropenia was worse (P<0.001) in group B. Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.005 respectively) in group B. Conclusions: Although RR, PFS, OS are similar in both groups, toxicity is significantly worse in group B and therefore further investigation of PV is of no value. No significant financial relationships to disclose.

scholarly journals Is There any Relationship Between the Grade of Mucoid Degeneration of Torn Menisci and Biochemical Marker Levels in Synovial Fluid?

2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0019
Author(s):  
Halit İbrahim Pınar ◽  
Oktay Iscen ◽  
Didem Keles ◽  
Sermin Ozkal ◽  
Gulgun Oktay
Keyword(s):  
Synovial Fluid ◽  
Control Group ◽  
Meniscal Tears ◽  
Mucoid Degeneration ◽  
Group A ◽  
The Difference ◽  
Grade 3 ◽  
Group B ◽  
Stage 1 ◽  
Staging Classification

Objectives: Mucoid degeneration (MD) leads to nontraumatic tears of the meniscus even in the young population. The tears are often irrepairable. The purpose of this study is to find out if there is any relationship between the severity of mucoid degeneration (MD) and the biochemical environment of the knee. Our hypothesis is that meniscal tears due to more severe MD are associated with higher levels of markers in the synovial fluid. Methods: Synovial fluid samples were taken during isolated arthroscopic meniscectomies. Samples of excised menisci were sent to the department of pathology for grading of MD. According to the Copenhaver staging classification, stage 1-2 menisci comprised group A (n:13), and grade 3 menisci group B (n:19). Cases with instability and with greater than grade 2 chondral lesions were excluded. Synovial fluid samples were also aspirated from 9 normal knees of individuals operated from other sites of lower extremities; these comprised the control group (C). The synovial fluids were examined for MMP-3,TIMP-1,COMP and proteoglycan (PG)fragment levels. Results were statistically analyzed with nonparametric Mann Whitney's U test. Results: PG fragment levels were significantly higher in group B as compared to group A (p=0.044).When groups B and C were compared, the difference between PG fragment levels almost displayed significance (p=0.055).There were no significant differences between the groups A,B and C for MMP-3,TIMP-1,and COMP levels. MMP-3 levels were significantly higher for traumatic meniscal tears than nontraumatic tears (p=0.025). Conclusion: In this study, our hypothesis was partially confirmed. Higher levels of PG fragments were found in knees with higher grade of meniscal mucoid degeneration. MD may be associated with an insidious degenerative process in the knee.

scholarly journals Effectiveness of Tramadol in Controlling Postanesthetic Shivering

2021 ◽  
Vol 15 (10) ◽  
pp. 3497-3499
Author(s):  
Muhammad Arif Baloch ◽  
Nazeer Ahmed ◽  
Muhammad Sharif ◽  
Zafar Ullah ◽  
Yasir Reda Toble
Keyword(s):  
Control Group ◽  
P Value ◽  
Study Objective ◽  
Management Group ◽  
Postanesthetic Shivering ◽  
Effective Option ◽  
Group A ◽  
Grade 3 ◽  
Group B ◽  
Objective Side

Objectives: The objective of the study was to assess the effectiveness of intravenous tramadol in controlling post anesthetic shivering and to assess which of the dose of drug is safe and effective. Material and Methods: In this study we included 120 patients age >18 years of ASA class I & II who underwent any surgical procedure under spinal/general anesthesia. Patients were divided into 3 groups of equal size of 40 subjects. Group A; in these patients tramadol 0.25 mg/kg I/V was given for shivering management. Group B; in these patients Tramadol 0.5 mg/kg I/V was given and Group C (control group); in these patients normal saline 0.05 ml/kg I/V was given. The adequate control of shivering was the main study objective. Side effects of tramadol at different doses were also observed. Results: At five minutes, Grade 0,1 and 2 shivering were observed in 23 patients in group A and 31 patients in group B while in group C grade 3 and 4 shivering were observed. High grade (3 and 4) shivering were significantly high in group C than group A and B (p-value= 0.005). Similarly, at 10 minutes, grade 3 and 4 shivering were significantly high in group C than group A and B (p-value 0.005). Conclusion: IV 0.25 mg/Kg is an effective option for control of post-anesthesia shivering with minimal side effect profile. So low dose tramadol can be used as a first option for post-anesthesia shivering control. Keywords: Anesthesia, Shivering, Tramadol.

Gamma Knife surgery as sole treatment for multiple brain metastases: 2-center retrospective review of 1508 cases meeting the inclusion criteria of the JLGK0901 multi-institutional prospective study

2010 ◽  
Vol 113 (Special_Supplement) ◽  
pp. 48-52 ◽  
Author(s):  
Toru Serizawa ◽  
Masaaki Yamamoto ◽  
Yasunori Sato ◽  
Yoshinori Higuchi ◽  
Osamu Nagano ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Gamma Knife ◽  
Class Ii ◽  
Hazard Ratio ◽  
Gamma Knife Surgery ◽  
Inclusion Criteria ◽  
Primary Tumors ◽  
Poor Prognostic Factor ◽  
Group A ◽  
Group B

Object The authors retrospectively reviewed the results of Gamma Knife surgery (GKS) used as the sole treatment for brain metastases in patients who met the eligibility criteria for the ongoing JLGK0901 multi-institutional prospective trial. They also discuss the anticipated results of the JLGK0901 study. Methods Data from 1508 consecutive cases were analyzed. All of the patients were treated at the Gamma Knife House of Chiba Cardiovascular Center or the Mito Gamma House of Katsuta Hospital between 1998 and 2007 and met the following JLGK0901 inclusion criteria: 1) newly diagnosed brain metastases, 2) 1–10 brain lesions, 3) less than 10 cm3 volume of the largest tumor, 4) no more than 15 cm3 total tumor volume, 5) no findings of CSF dissemination, and 6) no impairment of activities of daily living (Karnofsky Performance Scale score < 70) due to extracranial disease. At the initial treatment, all visible lesions were irradiated with GKS without upfront whole-brain radiation therapy. Thereafter, gadolinium-enhanced MR imaging was performed every 2–3 months, and new distant lesions were appropriately retreated with GKS. Patients were divided into groups according to numbers of tumors: Group A, single lesions (565 cases); Group B, 2–4 tumors (577 cases); and Group C, 5–10 tumors (366 cases). The differences in overall survival (OS) were compared between groups. Results The median age of the patients was 66 years (range 19–96 years). There were 963 men and 545 women. The primary tumors were in the lung in 1114 patients, gastrointestinal tract in 179, breast in 105, urinary tract in 66, and other sites in 44. The overall mean survival time was 0.78 years (0.99 years for Group A, 0.68 years for Group B, and 0.62 years for Group C). The differences between Groups A and B (p < 0.0001) and between Groups B and C (p = 0.0312) were statistically significant. Multivariate analysis revealed significant prognostic factors for OS to be sex (poor prognostic factor: male, p < 0.0001), recursive partitioning analysis class (Class I vs Class II and Class II vs III, both p < 0.0001), primary site (lung vs breast, p = 0.0047), and number of tumors (Group A vs Group B, p < 0.0001). However, no statistically difference was detected between Groups B and C (p = 0.1027, hazard ratio 1.124, 95% CI 0.999–1.265). Conclusions The results of this retrospective analysis revealed an upper CI of 1.265 for the hazard ratio, which was lower than the 1.3 initially set by the JLGK0901 study. The JLGK0901 study is anticipated to show noninferiority of GKS as sole treatment for patients with 5–10 brain metastases compared with those with 2–4 in terms of OS.

Clinical effect of Suvarna Bindu Prashan

2017 ◽  
Vol 2 (3) ◽  
Author(s):  
Patil Aniket ◽  
Dindore Pallavi ◽  
Arbar Aziz ◽  
Kadam Avinash ◽  
Saroch Vikas
Keyword(s):  
Physical Health ◽  
Eating Habits ◽  
Control Group ◽  
Inform Consent ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Immune Booster ◽  
Mental And Physical Health ◽  
Apparently Healthy

The quest for excellence in mental and physical health is not new. We find various references and formulations in Ayurvedic classics meant for promoting mental and physical health of a child. Suvarna Prashan is one of the formulations explained in age old Ayurvedic classic Kashyap Samhita. This formulation is very widely used now days as a memory and immune booster for children. But there is very little systematic documented study which can be used to evaluate the efficacy of the formulation. Suvarna Bhasma was prepared in Ayurved Rasayani Pharmacy, Pune. Madhu and Ghrita were collected from KLE Ayurveda Pharmacy, Belgaum. Suvarna Bindu Prashan was prepared in KLE Ayurved pharmacy, Belgaum. It contains Suvarna Bhasma, Ghrita and Madhu. Twenty apparently healthy male and female children with age group of three to four years were ready to sign inform consent form were selected into two groups each. Subjects in Group A received Suvarna Bindu Prashan where as Group B (Control group) did not receive any treatment. Both the groups were observed for six months. Children in Suvarna Bindu Prashan group showed significant reduction in the scores of eating habits, behavior, mood, temperament and scores of event of illness. However there was no significant difference in the score of sleeping habit. There was significant increase in IQ percentage.

scholarly journals Microecological preparation combined with an modified low-carbon diet improves glucolipid metabolism and cardiovascular complication in obese patients

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Jianguo Liu ◽  
Liehui Xiao ◽  
Hezhongrong Nie ◽  
Yong Pan ◽  
Yan Liu ◽  
...  
Keyword(s):  
Intestinal Barrier ◽  
Intestinal Barrier Function ◽  
Control Group ◽  
Obese Patients ◽  
Carotid Atherosclerotic Plaque ◽  
Low Carbon ◽  
Balanced Diet ◽  
Group A ◽  
Group B ◽  
Control Group Group

Abstract Objective To investigate the impact of microecological preparation combined with modified low-carbon diet on the glucolipid metabolism and cardiovascular complication in obese patients. Methods From August 2017 to July 2020, 66 obese patients were recruited, and administrated with an modified low-carbon diet with (group A) or without (Group B) microecology preparation and a balanced diet in control group (group C) for 6 months. Meanwhile, 20 volunteers administrated with a balanced diet were recruited as the healthy control group (group D). Results After 6-month intervention, obese subjects in group A and B showed significant improvement of body and liver fat mass, reduction of serum lipid levels, intestinal barrier function markers, insulin resistance index (IRI), high blood pressure (HBP) and carotid intima thickness, as compared with subjects in group C. More importantly, subjects in group A had better improvement of vascular endothelial elasticity and intimal thickness than subjects in group B. However, these intervention had no effect on carotid atherosclerotic plaque. Conclusion Administration of microecological preparation combined with modified low-carbon diet had better improvement of intestinal barrier function, glucose and lipid metabolism, and cardiovascular complications than low-carbon diet in obese patients, but the effect of a simple low-carb diet on carotid atherosclerotic plaque need to be further addressed.

scholarly journals 439 Conservative Versus Surgical Management of Complicated Diverticulitis - A Retrospective Study of Long-Term Outcomes

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Durity ◽  
G Elliott ◽  
T Gana
Keyword(s):  
Complicated Diverticulitis ◽  
Complication Rates ◽  
Long Term Outcomes ◽  
Female Ratio ◽  
Stoma Reversal ◽  
Group A ◽  
Grade 3 ◽  
Group B

Abstract Introduction Management of complicated diverticulitis has shifted towards a conservative approach over time. This study evaluates the feasibility and long-term outcomes of conservative management. Method We retrospectively evaluated a consecutive series of patients managed with perforated colonic diverticulitis from 2013-2017. Results Seventy-three (73) patients were included with a male to female ratio of 1:2. Thirty-one (31) underwent Hartmann’s procedure (Group A) and 42 patients were managed with antibiotics +/- radiological drainage (Group B). Mean follow-up was 64.9 months (range 3-7 years). CT Grade 3 and 4 disease was observed in 64.5% and 40.4% of Group A and Group B patients, respectively. During follow-up, 9 (21.4%) Group B patients required Hartmann’s. Group A had longer median length of stay compared to Group B (25.1 vs 9.2 days). Post-operative complications occurred in 80.6% with 40% being Clavien-Dindo grade III or higher in group A. Stoma reversal was performed in 8 patients (25.8%). Conclusions In carefully selected cases, complicated diverticulitis including CT grade 3 and 4 disease, can be managed conservatively with acceptable recurrence rates (16.7% at 30 days, 4.8% at 90 days, 19.0% at 5 years). Surgical intervention on the other hand, carries high post-operative complication rates and low stoma reversal rates.

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

scholarly journals The Bone Buttress Theory: The Effect of the Mechanical Loading of Bone on the Osseointegration of Dental Implants

Biology ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. 12
Author(s):  
David Chavarri-Prado ◽  
Aritza Brizuela-Velasco ◽  
Ángel Álvarez-Arenal ◽  
Markel Dieguez-Pereira ◽  
Esteban Pérez-Pevida ◽  
...  
Keyword(s):  
Dental Implants ◽  
Mechanical Loading ◽  
Bone Growth ◽  
Bone Matrix ◽  
Test Group ◽  
Control Group ◽  
Group A ◽  
Bone To Implant Contact ◽  
The Stability ◽  
Group B

Objectives: To determine the effect of mechanical loading of bone on the stability and histomorphometric variables of the osseointegration of dental implants using an experimental test in an animal model. Materials and Methods: A total of 4 human implants were placed in both tibiae of 10 New Zealand rabbits (n = 40). A 6-week osseointegration was considered, and the rabbits were randomly assigned to two groups: Group A (Test group) included 5 rabbits that ran on a treadmill for 20 min daily during the osseointegration period; Group B (Controls) included the other 5 that were housed conventionally. The monitored variables were related to the primary and secondary stability of the dental implants (implant stability quotient—ISQ), vertical bone growth, bone to implant contact (BIC), area of regenerated bone and the percentage of immature matrix. Results: The results of the study show a greater vertical bone growth (Group A 1.26 ± 0.48 mm, Group B 0.32 ± 0.47 mm, p < 0.001), higher ISQ values (Group A 11.25 ± 6.10 ISQ, 15.73%; Group B 5.80 ± 5.97 ISQ, 7.99%, p = 0.006) and a higher BIC (Group A 19.37%, Group B 23.60%, p = 0.0058) for implants in the test group, with statistically significant differences. A higher percentage of immature bone matrix was observed for implants in the control group (20.68 ± 9.53) than those in the test group (15.38 ± 8.84) (p = 0.108). A larger area of regenerated bone was also observed for the test implants (Group A 280.50 ± 125.40 mm2, Group B 228.00 ± 141.40 mm2), but it was not statistically significant (p = 0.121). Conclusions: The mechanical loading of bone improves the stability and the histomorphometric variables of the osseointegration of dental implants.

Glycine and L-Arginine supplementation ameliorates gastro-duodenal toxicity in a rat model of NSAID (Diclofenac)-gastroenteropathy via inhibition of oxidative stress

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Akinleye Stephen Akinrinde ◽  
Halimot Olawalarami Hameed
Keyword(s):  
Oxidative Stress ◽  
Total Protein ◽  
Therapeutic Index ◽  
Control Treatment ◽  
Control Group ◽  
Protective Effects ◽  
Serum Total Protein ◽  
Significant Amelioration ◽  
Group A ◽  
Group B

Abstract Objectives This study examined the possible protective roles of exogenous glycine (Gly) and L-Arginine (l-Arg) against Diclofenac (DIC)-induced gastro-duodenal damage in rats. Methods Rats were divided into Group A (control), Group B (DIC group) and Groups C–F which were pre-treated for five days with Gly1 (250 mg/kg), Gly2 (500 mg/kg), l-Arg1 (200 mg/kg) and l-Arg2 (400 mg/kg), respectively, before co-treatment with DIC for another three days. Hematological, biochemical and histopathological analyses were then carried out. Results DIC produced significant (p<0.05) reduction in PCV (13.82%), Hb (46.58%), RBC (30.53%), serum total protein (32.72%), albumin (28.44%) and globulin (38.01%) along with significant (p<0.05) elevation of serum MPO activity (83.30%), when compared with control. In addition, DIC increased gastric H2O2 and MDA levels by 33.93 and 48.59%, respectively, while the duodenal levels of the same parameters increased by 19.43 and 85.56%, respectively. Moreover, SOD, GPx and GST activities in the DIC group were significantly (p<0.05) reduced in the stomach (21.12, 24.35 and 51.28%, respectively) and duodenum (30.59, 16.35 and 37.90%, respectively), compared to control. Treatment with Gly and l-Arg resulted in significant amelioration of the DIC-induced alterations although l-Arg produced better amelioration of RBC (29.78%), total protein (10.12%), albumin (9.93%) and MPO (65.01%), compared to the DIC group. The protective effects of both amino acids against oxidative stress parameters and histological lesions were largely similar. Conclusions The data from this study suggest that Gly or l-Arg prevented DIC-induced gastro-duodenal toxicity and might, therefore be useful in improving the therapeutic index of DIC.

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