Matches in SemOpenAlex for { <https://semopenalex.org/work/W2537615087> ?p ?o ?g. }
Showing items 1 to 76 of
76
with 100 items per page.
- W2537615087 endingPage "6025" @default.
- W2537615087 startingPage "6025" @default.
- W2537615087 abstract "6025 Background: Decision making during early oncology drug development remains very empirical. A drug-disease simulation model to predict expected clinical response and survival in phase III studies from observed longitudinal tumor size in phase II trials offers a science-based alternative. Methods: We developed the following: 1) longitudinal exposure-response models of drug effect (and resistance) on tumor growth dynamics based on phase II data on capecitabine (X) in metastatic breast (MBC) and colorectal cancer (MCRC) and on historical phase III data on docetaxel (T) in MBC and 5-FU in MCRC; and 2) a survival model relating change in tumor size and patient characteristics to survival time in MBC and MCRC based on phase III data. The models were validated and used to predict expected anti-tumor response and survival in phase III studies of XT vs. T alone in MBC and X vs. 5-FU in MCRC. Multiple replicates (n = 1000) of simulated phase III studies were compared to actual results. Results: Change of tumor size and survival time distributions in X arms were well predicted. In MBC, expected median (90% prediction interval) survival for patients treated with XT was 412 (range 330 to 526) days (vs. 431 days observed) with an improvement over T of 57 days (range -17 to 148) (vs. 78 days observed). For MCRC patients, X treatment resulted in a potential survival improvement of 39 (range -21 to 110) days (vs. 35 days observed) compared to patients treated with 5-FU. Conclusions: The dose-tumor size-survival model succeeded in predicting survival in phase III trials based on X phase II data in MBC (in combination with T) and as a single agent in MCRC. This model is a useful tool to compare expected clinical response of new compounds to various competitors and to support end-of-phase II decisions and design of phase III studies. [Table: see text]" @default.
- W2537615087 created "2016-10-28" @default.
- W2537615087 creator A5023543619 @default.
- W2537615087 creator A5032960345 @default.
- W2537615087 creator A5040662613 @default.
- W2537615087 creator A5041912334 @default.
- W2537615087 creator A5065804693 @default.
- W2537615087 creator A5071234082 @default.
- W2537615087 creator A5072207853 @default.
- W2537615087 creator A5078902632 @default.
- W2537615087 creator A5087719732 @default.
- W2537615087 creator A5090645179 @default.
- W2537615087 date "2006-06-20" @default.
- W2537615087 modified "2023-10-18" @default.
- W2537615087 title "Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent" @default.
- W2537615087 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.6025" @default.
- W2537615087 hasPublicationYear "2006" @default.
- W2537615087 type Work @default.
- W2537615087 sameAs 2537615087 @default.
- W2537615087 citedByCount "15" @default.
- W2537615087 countsByYear W25376150872012 @default.
- W2537615087 countsByYear W25376150872013 @default.
- W2537615087 countsByYear W25376150872014 @default.
- W2537615087 countsByYear W25376150872015 @default.
- W2537615087 countsByYear W25376150872016 @default.
- W2537615087 countsByYear W25376150872023 @default.
- W2537615087 crossrefType "journal-article" @default.
- W2537615087 hasAuthorship W2537615087A5023543619 @default.
- W2537615087 hasAuthorship W2537615087A5032960345 @default.
- W2537615087 hasAuthorship W2537615087A5040662613 @default.
- W2537615087 hasAuthorship W2537615087A5041912334 @default.
- W2537615087 hasAuthorship W2537615087A5065804693 @default.
- W2537615087 hasAuthorship W2537615087A5071234082 @default.
- W2537615087 hasAuthorship W2537615087A5072207853 @default.
- W2537615087 hasAuthorship W2537615087A5078902632 @default.
- W2537615087 hasAuthorship W2537615087A5087719732 @default.
- W2537615087 hasAuthorship W2537615087A5090645179 @default.
- W2537615087 hasConcept C121608353 @default.
- W2537615087 hasConcept C126322002 @default.
- W2537615087 hasConcept C143998085 @default.
- W2537615087 hasConcept C2777909004 @default.
- W2537615087 hasConcept C2781190966 @default.
- W2537615087 hasConcept C31760486 @default.
- W2537615087 hasConcept C526805850 @default.
- W2537615087 hasConcept C535046627 @default.
- W2537615087 hasConcept C71924100 @default.
- W2537615087 hasConceptScore W2537615087C121608353 @default.
- W2537615087 hasConceptScore W2537615087C126322002 @default.
- W2537615087 hasConceptScore W2537615087C143998085 @default.
- W2537615087 hasConceptScore W2537615087C2777909004 @default.
- W2537615087 hasConceptScore W2537615087C2781190966 @default.
- W2537615087 hasConceptScore W2537615087C31760486 @default.
- W2537615087 hasConceptScore W2537615087C526805850 @default.
- W2537615087 hasConceptScore W2537615087C535046627 @default.
- W2537615087 hasConceptScore W2537615087C71924100 @default.
- W2537615087 hasIssue "18_suppl" @default.
- W2537615087 hasLocation W25376150871 @default.
- W2537615087 hasOpenAccess W2537615087 @default.
- W2537615087 hasPrimaryLocation W25376150871 @default.
- W2537615087 hasRelatedWork W1971387685 @default.
- W2537615087 hasRelatedWork W2004396656 @default.
- W2537615087 hasRelatedWork W2052195758 @default.
- W2537615087 hasRelatedWork W2058292467 @default.
- W2537615087 hasRelatedWork W2122311431 @default.
- W2537615087 hasRelatedWork W2145954767 @default.
- W2537615087 hasRelatedWork W2266510244 @default.
- W2537615087 hasRelatedWork W2737206118 @default.
- W2537615087 hasRelatedWork W4252495345 @default.
- W2537615087 hasRelatedWork W4253360580 @default.
- W2537615087 hasVolume "24" @default.
- W2537615087 isParatext "false" @default.
- W2537615087 isRetracted "false" @default.
- W2537615087 magId "2537615087" @default.
- W2537615087 workType "article" @default.