FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2906134828> ?p ?o ?g. }

• W2906134828 endingPage "S379" @default.
• W2906134828 startingPage "S379" @default.
• W2906134828 abstract "When assessing the value of innovative medicines Health Authorities are often faced with immature overall survival (OS) data from regulatory clinical trials. The aim of our study was to assess the OS benefits of ribociclib combined with letrozole (RIB+LTZ) for first-line treatment in postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer who had not received previous systemic therapy for advanced disease, using anchored adjusted indirect comparison with more mature data. We performed an anchored indirect comparison using simulated treatment comparison (STC) (PMID:25795232) which relay on regression methods to adjust for potential imbalance in effect modifiers (age, bone metastasis, previous chemotherapy, previous adjuvant endocrine therapy). We combined individual patient data (n=668) from the MONALEESA-2 trial (NCT01958021) with median follow-up of 15 months and aggregate data (n=916) from a phase III study of letrozole (LTZ) versus tamoxifen as first-line therapy of advanced breast cancer (PMID:12775735) with longer follow-up time (32 months). Different accelerated time failure models were tested to assess effect modifiers over OS. The Weibull AFT regression model was assumed not only because of its statistical properties (low AIC value) but also because of the clinical and biological plausibility of the extrapolated share of the survival beyond trial data observation. Indirect comparison with STC suggests a significantly 48% reduction in the risk of death for the use of RIB+LTZ relative to LTZ (HR=0.37; 95%CI: 0.34-0.39). Estimated adjusted median OS was 68 months for RIB+LTZ and 36 months for LTZ. The latter compares well with the observed median OS of 34 months (PMID: 12775735) and the former will only occur with longer follow-up in the MONALEESA-2 trial. Adjusted indirect comparison methods are useful to inform about early adoption of innovation in the absence of mature overall survival data from regulatory clinical trials." @default.
• W2906134828 created "2019-01-01" @default.
• W2906134828 creator A5017843601 @default.
• W2906134828 creator A5042269235 @default.
• W2906134828 creator A5060512506 @default.
• W2906134828 date "2018-10-01" @default.
• W2906134828 modified "2023-09-28" @default.
• W2906134828 title "PRM134 - USING ADJUSTED INDIRECT COMPARISON IN HTA TO OVERCOME SHORT FOLLOW-UP TIME IN REGULATORY RANDOMIZED CONTROLED CLINICAL TRIALS: RIBOCICLIB AS FIRST-LINE THERAPY FOR HR-POSITIVE, ADVANCED BREAST CANCER" @default.
• W2906134828 doi "https://doi.org/10.1016/j.jval.2018.09.2254" @default.
• W2906134828 hasPublicationYear "2018" @default.
• W2906134828 type Work @default.
• W2906134828 sameAs 2906134828 @default.
• W2906134828 citedByCount "0" @default.
• W2906134828 crossrefType "journal-article" @default.
• W2906134828 hasAuthorship W2906134828A5017843601 @default.
• W2906134828 hasAuthorship W2906134828A5042269235 @default.
• W2906134828 hasAuthorship W2906134828A5060512506 @default.
• W2906134828 hasBestOaLocation W29061348281 @default.
• W2906134828 hasConcept C121608353 @default.
• W2906134828 hasConcept C126322002 @default.
• W2906134828 hasConcept C143998085 @default.
• W2906134828 hasConcept C168563851 @default.
• W2906134828 hasConcept C2777176818 @default.
• W2906134828 hasConcept C2778812593 @default.
• W2906134828 hasConcept C530470458 @default.
• W2906134828 hasConcept C535046627 @default.
• W2906134828 hasConcept C71924100 @default.
• W2906134828 hasConceptScore W2906134828C121608353 @default.
• W2906134828 hasConceptScore W2906134828C126322002 @default.
• W2906134828 hasConceptScore W2906134828C143998085 @default.
• W2906134828 hasConceptScore W2906134828C168563851 @default.
• W2906134828 hasConceptScore W2906134828C2777176818 @default.
• W2906134828 hasConceptScore W2906134828C2778812593 @default.
• W2906134828 hasConceptScore W2906134828C530470458 @default.
• W2906134828 hasConceptScore W2906134828C535046627 @default.
• W2906134828 hasConceptScore W2906134828C71924100 @default.
• W2906134828 hasLocation W29061348281 @default.
• W2906134828 hasOpenAccess W2906134828 @default.
• W2906134828 hasPrimaryLocation W29061348281 @default.
• W2906134828 hasRelatedWork W1491737910 @default.
• W2906134828 hasRelatedWork W1971410221 @default.
• W2906134828 hasRelatedWork W2015092588 @default.
• W2906134828 hasRelatedWork W2081092072 @default.
• W2906134828 hasRelatedWork W2090744251 @default.
• W2906134828 hasRelatedWork W2108336499 @default.
• W2906134828 hasRelatedWork W2167166423 @default.
• W2906134828 hasRelatedWork W2172254302 @default.
• W2906134828 hasRelatedWork W2464051959 @default.
• W2906134828 hasRelatedWork W2517521993 @default.
• W2906134828 hasVolume "21" @default.
• W2906134828 isParatext "false" @default.
• W2906134828 isRetracted "false" @default.
• W2906134828 magId "2906134828" @default.
• W2906134828 workType "article" @default.