scholarly journals Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis after Laparoscopic Surgery for Colorectal Cancer. the PRO-LAPS II Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1064-1064
Author(s):  
Cecilia Becattini ◽  
Ugo Pace ◽  
Felice Pirozzi ◽  
Giampiero Avruscio ◽  
Annibale Donini ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Clinical Benefit ◽  
Cancer Surgery ◽  
Study Patient ◽  
Primary Study ◽  
Efficacy And Safety ◽  
Antithrombotic Prophylaxis ◽  
Study Results ◽  
Bayer Healthcare

Abstract Background The clinical benefit of extending prophylaxis for venous thromboembolism (VTE) beyond hospital discharge after laparoscopic surgery for cancer is unclear. The efficacy and safety of thromboprophylaxis with direct oral anticoagulants in cancer surgery is unexplored. Methods PROLAPS II is an investigator-initiated, prospective, randomized, double-blind study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban compared with placebo after laparoscopic surgery for colorectal cancer (NCT03055026). All patients received antithrombotic prophylaxis with low molecular-weight heparin for 7±2 days and were then randomized to receive rivaroxaban (10 mg once daily) or placebo for the following 3 weeks (up to day 28±2 from surgery). The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT) or VTE-related death within 28±2 days from laparoscopic surgery. The primary safety outcome was ISTH-defined major bleeding. By assuming an 8% incidence of primary study outcome in patients randomized to placebo and a 60% reduction with rivaroxaban, 323 patients per group were necessary to show the superiority of rivaroxaban. Results. Patient recruitment in PROLAPS II study was preliminary closed in June 7 th, 2021 due to study drug expiry, after the inclusion of 577 patients. The main patients features are reported in the Table. Study results will be available after the last study patient will complete the 90-day follow-up (scheduled on September 7th, 2021) and will be ready to be presented at the ASH 2021 Congress. Conclusion PROLAPS II is the first study with an oral anti-Xa agent in cancer surgery. The study has the potential to improve clinical practice by assessing the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal cancer. Figure 1 Figure 1. Disclosures Becattini: Bayer HealthCare: Honoraria; Daiichi Sankyo: Honoraria; Bristol Myers Squibb: Honoraria. Dentali: Pfizer: Honoraria; Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria; Bayer: Honoraria; Sanofi: Honoraria; Novartis: Honoraria; Boehringer: Honoraria; Alfa Sigma: Honoraria. Agnelli: Bayer HealthCare: Honoraria; Daiichi Sankyo: Honoraria; Pfizer: Honoraria; Bristol Myers Squibb: Honoraria.

scholarly journals Colorectal Cancer Surgery Quality in Manitoba: A Population-Based Descriptive Analysis

2021 ◽  
Vol 28 (3) ◽  
pp. 2239-2247
Author(s):  
Iresha Ratnayake ◽  
Jason Park ◽  
Natalie Biswanger ◽  
Allison Feely ◽  
Grace Musto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Laparoscopic Surgery ◽  
Descriptive Analysis ◽  
Population Based ◽  
Cancer Surgery ◽  
Formal Structure ◽  
Colorectal Cancer Surgery ◽  
Surgical Quality ◽  
Clinical Variation

Unwarranted clinical variation in healthcare impacts access, productivity, performance, and outcomes. A strategy proposed for reducing unwarranted clinical variation is to ensure that population-based data describing the current state of health care services are available to clinicians and healthcare decision-makers. The objective of this study was to measure variation in colorectal cancer surgical treatment patterns and surgical quality in Manitoba and identify areas for improvement. This descriptive study included individuals aged 20 years or older who were diagnosed with invasive cancer (adenocarcinoma) of the colon or rectum between 1 January 2010 and 31 December 2014. Laparoscopic surgery was higher in colon cancer (24.1%) compared to rectal cancer (13.6%). For colon cancer, the percentage of laparoscopic surgery ranged from 12.9% to 29.2%, with significant differences by regional health authority (RHA) of surgery. In 86.1% of colon cancers, ≥12 lymph nodes were removed. In Manitoba, the negative circumferential resection margin for rectal cancers was 96.9%, and ranged from 96.0% to 100.0% between RHAs. The median time between first colonoscopy and resection was 40 days for individuals with colon cancer. This study showed that high-quality colorectal cancer surgery is being conducted in Manitoba along with some variation and gaps in quality. As a result of this work, a formal structure for ongoing measuring and reporting surgical quality has been established in Manitoba. Quality improvement initiatives have been implemented based on these findings and periodic assessments of colorectal cancer surgery quality will continue.

Clinical benefit rate (CBR) of panitumumab monotherapy among patients with KRAS wild-type metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14176-e14176
Author(s):  
Hagen F. Kennecke ◽  
Howard John Lim ◽  
Balvindar Singh Johal ◽  
Muhammad Zulfiqar ◽  
Caroline Speers
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Primary Endpoint ◽  
Clinical Benefit ◽  
Single Agent ◽  
Wild Type ◽  
Clinical Benefit Rate ◽  
Previous Therapy ◽  
Study Results ◽  
Third Line

e14176 Background: Panitumumab (Pmab) improves progression free survival as first-, second- and third-line therapy for KRAS wild-type (wt) metastatic colorectal cancer (mCRC). Only in the third-line setting is there evidence of benefit of Pmab monotherapy. In this analysis of an exploratory biomarker study of Pmab monotherapy, the clinical benefit rate of Pmab according to previous lines of therapy is described. Methods: Patients (pts) with KRAS non-mutated, measurable MCRC previously treated with or ineligible for oxaliplatin/5-FU and irinotecan were treated with Pmab 6mg/kg IV q2w until progression or toxicity. The primary endpoint is clinical benefit rate (complete (CR) or partial response (PR) + prolonged stable disease (PSD) > = 24 weeks) by RECIST criteria. Results: The study completed accrual and (40) evaluable patients were treated between September 2009 and December 2011 of which 32 were evaluable for the primary endpoint. Median follow-up was 8.8 months, median age was 64.5 years and 90% were ECOG 0/1. Previous therapy was: 5-FU/Capecitabine(C) only in 12 pts, Irinotecan/5-FU/C only in 2 patients, Oxaliplatin/5-FU/C only in 3 pts, Oxaliplatin/Irinotecan/5-FU/C in 23 pts. 22 patients received prior Bevacizumab. Median number of cycles was 8 and 6 pts required a dose modification. There were 7 (22%) PRs and 7 (22%) pts experienced PSD >=24 weeks. Clinical benefit rate (PR+PSD) according to previous therapy was 33% (3/9) for 5FU/C only, 100% (2/2) Oxaliplatin/FU/C only, 0% (0/2) Irinotecan/FU/C only, and 47% (9/19) for Oxaliplatin/Irinotecan/5FU/C. Conclusions: Pmab monotherapy is well tolerated and response rates vary according to previous lines of therapy. Patients ineligible for irinotecan and/or oxaliplatin experience a high clinical benefit rate with single agent Panitumumab and should be considered for such therapy. Updated study results will be presented.

scholarly journals Efficacy of electro-acupuncture for gastrointestinal motility after colorectal cancer surgery: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
yixuan Feng ◽  
Muwen Qu ◽  
Xiumei Gao ◽  
yuru Zhang ◽  
Xiaoqiang Jia ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Gastrointestinal Motility ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Major Complication ◽  
Cancer Surgery ◽  
Psychological Disturbance ◽  
Colorectal Cancer Surgery ◽  
Routine Treatment ◽  
Study Results

Abstract Background Gastrointestinal dysfunction is a common and major complication after colorectal cancer surgery that results in significant psychological disturbance and economic burden. Although some studies have shown the potential therapeutic effect of acupuncture on gastrointestinal motility recovery, there is still a lack of high-quality evidence. Methods The trial is designed as a multicentre, parallel-group, randomized, single-blinded (outcome assessors), superiority, randomized trial. A total of 160 eligible patients will be randomly assigned to two groups: the electro-acupuncture (EA) group and the routine treatment (RT) group. Patients in the EA group will receive EA combined with routine treatment. EA will be administered for 30 minutes, once a day, starting 24 hours after surgery and lasting for 3 days. Patients in the RT group will receive routine intervention lasting until the patients are discharged from the hospital. The primary outcome will be the time to first flatus. The secondary outcomes will include the time to first defecation, visual analogue scale (VAS) scores for postoperative incision pain or abdominal pain, quality of recovery-40 (QOR-40) scores and the length of hospital stay. These outcomes will be evaluated at 24 h as well as on the 2nd and 3rd days after surgery. Any side effects of the treatment will be observed and recorded. Discussion We expect that the study results will provide high-level evidence to determine the effects of EA on gastrointestinal motility recovery after colorectal cancer surgery.

scholarly journals LB5. PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S810-S810
Author(s):  
Myron J Levin ◽  
Andrew Ustianowski ◽  
Stéphane De Wit ◽  
Odile Launay ◽  
Miles Avila ◽  
...  
Keyword(s):  
Safety Analysis ◽  
Controlled Study ◽  
Primary Study ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Research Support ◽  
Phase 3 ◽  
Increased Risk ◽  
Study Results ◽  
Exposure Prophylaxis

Abstract Background Vaccines effectively prevent COVID-19, but some individuals have medical comorbidities or receive therapies that impair their immune response to vaccination, or are ineligible for vaccination. For such individuals who remain at risk of COVID-19, monoclonal antibodies may provide additional rapid protection. AZD7442 comprises 2 fully human extended half-life SARS-CoV-2–neutralizing antibodies that bind distinct epitopes of the viral spike protein receptor binding domain. AZD7442 is in development for the prevention and treatment of COVID-19. Here, we report primary Phase 3 study results of AZD7442 for pre-exposure prophylaxis of symptomatic COVID-19. Methods PROVENT (NCT04625725) is a Phase 3, 2:1 randomized, double-blind, placebo-controlled study of a single 300-mg AZD7442 dose (2 intramuscular injections; 150 mg each of tixagevimab and cilgavimab) for symptomatic COVID-19 prevention. Participants were unvaccinated adults (≥ 18 years old) without prior SARS-CoV-2 infection, who may benefit from immunoprophylaxis with antibodies due to an increased risk of either inadequate response to vaccination or SARS-CoV-2 exposure. The primary study endpoints were first case of SARS-CoV-2 RT-PCR-positive symptomatic illness post dose and prior to Day 183 (efficacy), and safety of AZD7442. Results In total, 5197 participants (mean age 53.5 years, 46% female) were randomized and dosed (safety analysis set): AZD7442 n=3460; placebo n=1737. In the primary efficacy analysis (full pre-exposure analysis set, n=5172), AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval 46.0, 90.0) vs placebo (P< 0.001) (Table). Adverse events occurred in 35% and 34% of participants administered AZD7442 and placebo, respectively, and injection site reactions occurred in 2.4% and 2.1% of participants, respectively (safety analysis set). There was 1 case of severe/critical COVID-19 and 2 COVID-19–related deaths in the placebo arm. Conclusion The primary study endpoints were met: a one-time dose of AZD7442 demonstrated statistically significant protection against symptomatic COVID-19 and was well tolerated. AZD7442 is the first long-acting monoclonal antibody combination that represents a potential new option to augment COVID-19 prevention. PROVENT funding statement image Disclosures Myron J. Levin, MD, GSK group of companies (Employee, Research Grant or Support) Andrew Ustianowski, MBBS, Vir/GlaxoSmithKline (Advisor or Review Panel member) Stéphane De Wit, MD, Gilead (Grant/Research Support)Janssen (Grant/Research Support)Merck Sharpe & Dohme (Grant/Research Support)ViiV Healthcare (Grant/Research Support) Odile Launay, MD, PhD, AstraZeneca (Grant/Research Support)GlaxoSmithKline (Consultant, Grant/Research Support, Other Financial or Material Support, Data safety monitoring board)Johnson & Johnson (Consultant, Grant/Research Support)Moderna (Consultant)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Grant/Research Support) Miles Avila, MPH, GStat, AstraZeneca (Employee, Shareholder) Seth Seegobin, PhD, AstraZeneca (Employee, Shareholder) Alison Templeton, PhD, AstraZeneca (Employee, Shareholder) Yuan Yuan, PhD, AstraZeneca (Employee, Shareholder) Philip Ambery, FRCP, AstraZeneca (Employee, Shareholder) Rosalinda H. Arends, PhD, AstraZeneca (Employee, Shareholder) Rohini Beavon, PhD, AstraZeneca (Employee, Shareholder) Karen A. Near, MD, AstraZeneca (Employee, Shareholder) Kelly W. Padilla, PharmD, AstraZeneca (Employee, Shareholder) Konstantina Psachoulia, PhD, AstraZeneca (Employee, Shareholder) Audrey Sharbaugh, PhD, AstraZeneca (Employee, Shareholder) Katie Streicher, PhD, AstraZeneca (Employee, Shareholder) Menelas N. Pangalos, PhD, AstraZeneca (Employee, Shareholder) Mark T. Esser, PhD, AstraZeneca (Employee, Shareholder) Robert A. Gasser, Jr., MD, AstraZeneca (Employee, Shareholder)

scholarly journals Efficacy and Safety of Intraperitoneal Dexmedetomidine with Bupivacaine in Laparoscopic Colorectal Cancer Surgery, a Randomized Trial

Pain Medicine ◽  
2015 ◽  
Vol 16 (6) ◽  
pp. 1186-1194 ◽  
Author(s):  
Khaled Mohamed Fares ◽  
Sahar Abd-Elbaky Mohamed ◽  
Ahmad Mohammad Abd El-Rahman ◽  
Ashraf Amin Mohamed ◽  
Anwar Tawfik Amin
Keyword(s):  
Colorectal Cancer ◽  
Randomized Trial ◽  
Cancer Surgery ◽  
Efficacy And Safety ◽  
Colorectal Cancer Surgery
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