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Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

ABSTRACT: BACKGROUND:This is the first study investigating the safety and efficacy of the trifunctional antibody catumaxomab administered i.p. at the end of cytoreductive surgery and postoperatively prior to standard chemotherapy in patients with primary epithelial ovarian cancer (EOC). METHODS:Patients received i.p. catumaxomab 10??g intraoperatively and 10, 20, 50 and 150??g on days 7, 10, 13 and 16, respectively, postoperatively. After the study, patients received standard chemotherapy and were followed for 23 months. The primary endpoint was the rate of postoperative complications. RESULTS:Forty-one patients entered the study and were evaluable for safety and 34 were alive at 24 months. Complete tumour resection rate was 68%. Postoperative complications were observed in 51%, the most common anastomotic leakage (7%) and wound infections (5%). The most common catumaxomab-related adverse events were abdominal pain, nausea, vomiting and pyrexia. Thirty-nine percent discontinued catumaxomab therapy, and 98% received chemotherapy post study. Kaplan-Meier estimates of disease-free and overall survival after 24 months were 56% and 85%, respectively. CONCLUSIONS:Intra- and close postoperative catumaxomab seems feasible, but efficacy and safety were limited by postsurgical complications. In the future prospective trials are needed to investigate the best schedule of integration of catumaxomab into current treatment strategies for EOC.

SUBMITTER: Sehouli J

PROVIDER: S-EPMC4200087 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

Sehouli J J Reinthaller A A Marth C C Reimer D D Reimer T T Stummvoll W W Angleitner-Boubenizek L L Brandt B B Chekerov R R

British journal of cancer 20140916 8

<h4>Background</h4>This is the first study investigating the safety and efficacy of the trifunctional antibody catumaxomab administered i.p. at the end of cytoreductive surgery and postoperatively prior to standard chemotherapy in patients with primary epithelial ovarian cancer (EOC).<h4>Methods</h4>Patients received i.p. catumaxomab 10 μg intraoperatively and 10, 20, 50 and 150 μg on days 7, 10, 13 and 16, respectively, postoperatively. After the study, patients received standard chemotherapy a ...[more]

PMID: 25225907

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Project description:BackgroundPrasugrel and ticagrelor have demonstrated higher efficacy than clopidogrel in their main clinical trials for patients with acute coronary syndrome (ACS). However, the long-term prognosis and different clinical characteristics related to the type of antiplatelet prescription in current clinical practice ACS patients have not been analysed in depth. The objective of this study was to analyse the clinical profile of ACS and the efficacy and safety of novel oral P2Y12 inhibitors in current clinical practice patients discharged afterACS.MethodsWe collected data from the ACHILLES registry, and an observational, prospective and multicentre registry of patients discharged after ACS. We analysed baseline characteristics, clinical profile and therapy during ACS admission and compared with the different treatments at discharge. After 1 year of follow-up, ischaemic and major bleeding events were analysed. Multivariate Cox regression analysis and Kaplan Meier curves were also plotted.ResultsOf 1717 consecutive patients, 1294 (75.4%) were discharged with a P2Y12 inhibitor without oral anticoagulation. Novel oral P2Y12 inhibitors were indicated in 47%. Patients treated with clopidogrel were elderly (69.1 ± 13.4 vs 60.4 ± 11.5 years; P < .001) and had a higher prevalence of cardiovascular risk factors. GRACE and CRUSADE scores were higher in the clopidogrel than in novel oral P2Y12 inhibitors group (P < .001). After 1 year of follow-up, 64(5.0%/year) patients had a new myocardial infarction, 127(10.0%/year) had a major adverse cardiovascular event (MACE) and 78(6.1%/year) died. Patients treated with clopidogrel had a significantly higher annual rate of cardiovascular mortality, MACE and all-cause mortality (allP < .001) without differences in major bleeding (P = .587) compared with novel oral P2Y12 inhibitors. After multivariate adjustment for the main clinical variables related to adverse prognosis in ACS patients, the discharge with novel oral P2Y12 inhibitors therapy was independently associated with lower risk of all-cause mortality (HR0.49, 95% CI [0.24-0.98], P = .044) and lower risk of MACE (HR0.64, 95% CI [0.41-0.98], P = .044).ConclusionsIn this prospective, observational and current clinical practice ACS registry, the use of novel oral P2Y12 inhibitors was associated with a reduction in adverse events compared with clopidogrel in patients with ACS. Novel oral P2Y12 inhibitors prescription at discharge was independently associated with lower all-cause mortality and MACE without differences in bleeding events. However, clopidogrel remained the most common P2Y12 inhibitor employed for ACS, especially in older and high-risk patients.

Project description:ObjectiveThe primary objective of the trial was to assess the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee.DesignProspective, randomised, 2 years, assessor-blind, multicentre, superiority trial.SettingThe patients were enrolled between December 2015 and May 2018 from the outpatient clinics of three public high-volume arthroplasty hospitals (Finland).ParticipantsWe recruited 143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure. All the patients were suitable for both unicompartmental and total knee arthroplasties. Population was selected as the end-stage-isolated medial osteoarthritis.InterventionsAll patients, randomized 1:1, received a medial unicompartmental arthroplasty or a total knee arthroplasty through a similar midline skin incision. Patients were blinded to the type of arthroplasty for the whole 2 years of follow-up.Main outcome measuresPrimary outcome measure was between-group differences in the Oxford Knee Score (OKS) and secondary outcome Knee injury and Osteoarthritis Score (KOOS) at 2 years postoperatively. The changes within and between the groups were analysed with analysis of variance for repeated measurements.ResultsThe primary outcome was comparable for medial unicompartmental arthroplasty and total knee arthroplasty at 2 years. The mean difference in the OKS between the groups was 1.6 points (95% CI -0.7 to 3.9). In the KOOS subscales, the mean difference between the groups was 0.1 points (95% CI -4.8 to 5.0) for pain, 7.8 points (95% CI 1.5 to 14.0) for symptoms, 4.3 points (95% CI -0.6 to 9.2) for function in daily living, 4.3 points (95% CI -3.0 to 11.6) for function in sports, and 2.1 points (95% CI -4.8 to 9.1) for knee-related quality of life.ConclusionsThe recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years.Trial registration numberNCT02481427.

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Dataset Information

Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

Publications

Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

Similar Datasets

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