贝伐单抗 卵巢癌(AURELIA)研究结果

A service of the U.S. National Institutes of HealthParticipant FlowHide Participant FlowBaseline Characteristics Hide Baseline CharacteristicsOutcome MeasuresShow All Outcome MeasuresPercentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) [ Time Frame: Screening Visit, Every8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009)until cutoff date of 14 November 2011 ]Hide Outcome Measure 1Measure Type PrimaryMeasure Title Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)Measure Description Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigatorsaccording to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurabledisease), and for those with non-measurable disease presence or absence of lesions was noted.Time Frame Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011Safety Issue NoPopulation DescriptionExplanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomizationReporting GroupsDescriptionChemotherapy Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IVinfusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drugcould have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medicationwas implemented according to local practices.Chemotherapy + Bevacizumab Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IVinfusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drugcould have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medicationwas implemented according to local practices. The chosen chemotherapy was combined with bevacizumab10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusionsover 60 minutes and then 30 minutes, as tolerated.Measured ValuesChemotherapy Chemotherapy +BevacizumabNumber of Participants Analyzed[units: participants]182 179Percentage of Participants With Disease Progression or Death (Data Cutoff 14November 2011)[units: percentage of participants]92.3 78.8No statistical analysis provided for Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)2. Primary: P rogression Free Survival (PFS; Data Cutoff 14 November 2011) [ Time Frame: Screening Visit, Every 8 weeks (or 9 weeks ifreceiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14November 2011 ]Hide Outcome Measure 2Measure Type PrimaryMeasure Title Progression Free Survival (PFS; Data Cutoff 14 November 2011)Measure Description PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to theRECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence orabsence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.Time Frame Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011Safety Issue NoPopulation DescriptionExplanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.ITT Population; only participants with an event of progression or death were included in the analysisReporting GroupsDescriptionChemotherapy Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IVinfusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drugcould have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medicationwas implemented according to local practices.Chemotherapy + Bevacizumab Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IVinfusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drugcould have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medicationwas implemented according to local practices. The chosen chemotherapy was combined with bevacizumab10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusionsover 60 minutes and then 30 minutes, as tolerated.Measured ValuesChemotherapy Chemotherapy + BevacizumabNumber of Participants Analyzed[units: participants]168 141Progression Free Survival (PFS; Data Cutoff 14 November 2011)[units: months]Median (95% Confidence Interval)3.4 (2.10 to 3.75) 6.7 (5.62 to 7.79)Statistical Analysis 1 for Progression Free Survival (PFS; Data Cutoff 14 November 2011)Groups [1]All groupsMethod [2]Log RankP Value [3]<0.0001Hazard Ratio (HR) [4]0.37995% Confidence Interval0.296 to 0.485[1]Additional details about the analysis, such as null hypothesis and power calculation:No text entered.[2]Other relevant method information, such as adjustments or degrees of freedom:No text entered.[3]Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statisticalsignificance:No text entered.[4]Other relevant estimation information:Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), andplatinum-free interval (less than [<] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.Statistical Analysis 2 for Progression Free Survival (PFS; Data Cutoff 14 November 2011)Groups [1]All groupsMethod [2]Log RankP Value [3]<0.0001Hazard Ratio (HR) [4]0.46095% Confidence Interval0.366 to 0.577[1]Additional details about the analysis, such as null hypothesis and power calculation:No text entered.[2]Other relevant method information, such as adjustments or degrees of freedom:Unstratified analysis[3]Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statisticalsignificance:No text entered.[4]Other relevant estimation information:No text entered.Statistical Analysis 3 for Progression Free Survival (PFS; Data Cutoff 14 November 2011)Groups [1]All groupsMethod [2]Peto-Peto-PrenticeP Value [3]<0.0001[1]Additional details about the analysis, such as null hypothesis and power calculation:No text entered.[2]Other relevant method information, such as adjustments or degrees of freedom:Unstratified analysis[3]Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statisticalsignificance:No text entered.Statistical Analysis 4 for Progression Free Survival (PFS; Data Cutoff 14 November 2011)Groups [1]All groupsMethod [2]Peto-Peto-PrenticeP Value [3]<0.0001[1]Additional details about the analysis, such as null hypothesis and power calculation:No text entered.[2]Other relevant method information, such as adjustments or degrees of freedom:Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.[3]Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statisticalsignificance:No text entered.3. Secondary: P ercentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR)Per Modified RECIST (Data Cutoff 14 November 2011) [ Time Frame: Screening Visit, Every 8 weeks (or 9 weeks if receivingShow Outcome Measure 3Show Outcome Measure 4Show Outcome Measure 5Show Outcome Measure 6Show Outcome Measure 7Serious Adverse Events Show Serious Adverse EventsOther Adverse EventsShow Other Adverse EventsLimitations and Caveats Hide Limitations and CaveatsMore InformationHide More Informationphone: 1-800-821-8590e-mail: genentech@No publications provided by Hoffmann-La RochePublications automatically indexed to this study:Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. Erratum in: J Clin Oncol. 2014 Dec 10;32(35):4025.Responsible Party:Hoffmann-La Roche Identifier:NCT00976911History of ChangesOther Study ID Numbers:MO22224, 2009-011400-33Study First Received:September 14, 2009Results First Received:December 3, 2014Last Updated:February 24, 2015Health Authority:Spain: Ministry of Health。