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Statements

Subject Item
n2:RIV%2F00064165%3A_____%2F13%3A10189636%21RIV14-MZ0-00064165
rdf:type
n4:Vysledek skos:Concept
rdfs:seeAlso
http://dx.doi.org/10.1200/JCO.2012.46.4057
dcterms:description
Purpose To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission. Patients and Methods Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum-and taxane-based chemotherapy were randomly assigned at a ratio of 2: 1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response. Results Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, {= 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 {= 35U/mL after third cycle, 80.9%. Mean exposure to study treatment (+/- standard deviation) was 449.7 +/- 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization ({= 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization ({= 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response. Purpose To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission. Patients and Methods Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum-and taxane-based chemotherapy were randomly assigned at a ratio of 2: 1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response. Results Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, {= 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 {= 35U/mL after third cycle, 80.9%. Mean exposure to study treatment (+/- standard deviation) was 449.7 +/- 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization ({= 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization ({= 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.
dcterms:title
Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO-The MIMOSA Study Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO-The MIMOSA Study
skos:prefLabel
Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO-The MIMOSA Study Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO-The MIMOSA Study
skos:notation
RIV/00064165:_____/13:10189636!RIV14-MZ0-00064165
n4:predkladatel
n17:ico%3A00064165
n3:aktivita
n13:I n13:N
n3:aktivity
I, N
n3:cisloPeriodika
12
n3:dodaniDat
n6:2014
n3:domaciTvurceVysledku
n12:3630501
n3:druhVysledku
n15:J
n3:duvernostUdaju
n10:S
n3:entitaPredkladatele
n14:predkladatel
n3:idSjednocenehoVysledku
59208
n3:idVysledku
RIV/00064165:_____/13:10189636
n3:jazykVysledku
n16:eng
n3:klicovaSlova
carboplatin; radiotherapy; consolidation; survival; carcinoma; remission; antibody; chemotherapy; randomized-trial; gynecologic-oncology-group
n3:klicoveSlovo
n8:chemotherapy n8:carcinoma n8:antibody n8:radiotherapy n8:carboplatin n8:randomized-trial n8:gynecologic-oncology-group n8:survival n8:consolidation n8:remission
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[6E7BA1F601C5]
n3:nazevZdroje
Journal of Clinical Oncology
n3:obor
n18:FK
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
29
n3:rokUplatneniVysledku
n6:2013
n3:svazekPeriodika
31
n3:tvurceVysledku
Baumann, Klaus H. Simonelli, Cecilia Sehouli, Jalid Bertolotti, Monica Colombo, Nicoletta Meier, Werner Pinter, Tamas Scartoni, Simona Schmalfeldt, Barbara Pujade-Lauraine, Eric Berek, Jonathan S. del Campo, Jose Scambia, Giovanni Kurzeder, Christian Harter, Philipp Martoni, Andrea Selvaggi, Luigi Maggi, Carlo Alberto Holloway, Robert W. Cwiertka, Karel Casado, Antonio Pfisterer, Jacobus Cibula, David Sabbatini, Paul Capriati, Angela Vermorken, Jan B. Li, Andrew Wimberger, Pauline Bidzinski, Mariusz
n3:wos
000317831500018
s:issn
0732-183X
s:numberOfPages
8
n11:doi
10.1200/JCO.2012.46.4057